Inhixa · 4.5 Interaction with other medicinal products and other forms of interaction · 8

HOS-097993 · has-adverse-reaction-information · PDF-Seite 194

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, t

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097981 · has-adverse-reaction-information · PDF-Seite 136

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in 136 patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, thro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097987 · has-adverse-reaction-information · PDF-Seite 167

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical 167 patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic sy

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097975 · has-adverse-reaction-information · PDF-Seite 105

Summary of the safety profile 105 Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, thro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097957 · has-adverse-reaction-information · PDF-Seite 12

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in 12 patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, thro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097999 · has-adverse-reaction-information · PDF-Seite 221

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and ”Description of selected adverse reactions” below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, t

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098011 · has-adverse-reaction-information · PDF-Seite 267

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and “Description of selected adverse reactions” below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, t

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097969 · has-adverse-reaction-information · PDF-Seite 74

Summary of the safety profile 74 Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, thro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097963 · has-adverse-reaction-information · PDF-Seite 43

Summary of the safety profile 43 Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, thro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098005 · has-adverse-reaction-information · PDF-Seite 244

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of DVT following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of DVT in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of DVT following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day. In the clinical trials for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours. In clinical trials, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and “Description of selected adverse reactions” below). The safety profile of enoxaparin for extended treatment of DVT and PE in patients with active cancer is similar to its safety profile for the treatment of DVT and PE. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with enoxaparin treatment (see section 4.4). Tabulated list of adverse reactions Other adverse reactions observed in clinical trials and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Blood and the lymphatic system disorders Common: Haemorrhage, haemorrhagic anaemia*, t

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098007 · has-contraindication-information · PDF-Seite 262

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or any other of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4). Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium multiple dose vial formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).

HOS-097995 · has-contraindication-information · PDF-Seite 216

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or any other of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4). Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium multiple dose vial formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).

HOS-097989 · has-contraindication-information · PDF-Seite 189

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097965 · has-contraindication-information · PDF-Seite 70

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-098001 · has-contraindication-information · PDF-Seite 239

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or any other of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4). Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium multiple dose vial formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).

HOS-097953 · has-contraindication-information · PDF-Seite 8

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097983 · has-contraindication-information · PDF-Seite 163

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097971 · has-contraindication-information · PDF-Seite 101

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097977 · has-contraindication-information · PDF-Seite 132

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097959 · has-contraindication-information · PDF-Seite 39

Enoxaparin sodium is contraindicated in patients with: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1; • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 ); • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).

HOS-097988 · has-indication-information · PDF-Seite 183

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097976 · has-indication-information · PDF-Seite 126

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097970 · has-indication-information · PDF-Seite 95

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097964 · has-indication-information · PDF-Seite 64

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097982 · has-indication-information · PDF-Seite 157

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097952 · has-indication-information · PDF-Seite 2

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-098000 · has-indication-information · PDF-Seite 233

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-098006 · has-indication-information · PDF-Seite 256

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097958 · has-indication-information · PDF-Seite 33

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097994 · has-indication-information · PDF-Seite 210

Inhixa is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: • Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. • Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

HOS-097991 · has-interaction-information · PDF-Seite 193

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. Medicinal products increasing potassium levels Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097967 · has-interaction-information · PDF-Seite 73

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: 73  - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097997 · has-interaction-information · PDF-Seite 220

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097979 · has-interaction-information · PDF-Seite 135

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, 135  - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097955 · has-interaction-information · PDF-Seite 11

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, 11  - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097973 · has-interaction-information · PDF-Seite 104

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: 104  - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097985 · has-interaction-information · PDF-Seite 166

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, 166  - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. Medicinal products increasing potassium levels Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097961 · has-interaction-information · PDF-Seite 42

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: 42  - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-098003 · has-interaction-information · PDF-Seite 243

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-098009 · has-interaction-information · PDF-Seite 266

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2). Concomitant use with caution The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids. • Medicinal products increasing potassium levels Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).

HOS-097992 · has-pregnancy-information · PDF-Seite 193

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3). 193

HOS-097962 · has-pregnancy-information · PDF-Seite 43

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-098010 · has-pregnancy-information · PDF-Seite 266

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol. 266 Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097968 · has-pregnancy-information · PDF-Seite 74

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097998 · has-pregnancy-information · PDF-Seite 220

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol. 220 Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097974 · has-pregnancy-information · PDF-Seite 105

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097956 · has-pregnancy-information · PDF-Seite 12

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097980 · has-pregnancy-information · PDF-Seite 136

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097986 · has-pregnancy-information · PDF-Seite 167

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-098004 · has-pregnancy-information · PDF-Seite 243

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal. Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4). If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4). As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol. 243 Breast-feeding It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Inhixa can be used during breastfeeding. Fertility There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).

HOS-097972 · has-warning-information · PDF-Seite 101

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count 101 should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physici

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HOS-098008 · has-warning-information · PDF-Seite 262

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. 262 The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-097978 · has-warning-information · PDF-Seite 132

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count 132 should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physici

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HOS-097990 · has-warning-information · PDF-Seite 189

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (> 100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (> 100 days) of heparin-induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. 189 The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physici

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HOS-097960 · has-warning-information · PDF-Seite 39

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count 39 should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-097996 · has-warning-information · PDF-Seite 216

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. 216 The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-098002 · has-warning-information · PDF-Seite 239

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. 239 The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-097954 · has-warning-information · PDF-Seite 8

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count 8 should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-097966 · has-warning-information · PDF-Seite 70

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin- induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count 70 should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physicia

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HOS-097984 · has-warning-information · PDF-Seite 163

Traceability LMWHs are biological medicinal products. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dose and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required. History of HIT (> 100 days) Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3). Circulating antibodies may persist several years. Enoxaparin sodium is to be used with extreme caution in patients with a history (> 100 days) of heparin-induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin). Monitoring of platelet counts In patients with cancer with a platelet count below 80 G/L, anticoagulation treatment can only be considered on a case-by-case basis and careful monitoring is recommended. The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician. In practice, if a confirmed significant decrease of the pla

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