Arixtra · 4.1 Therapeutic indications · 5

HOS-093314 · has-adverse-reaction-information · PDF-Seite 6

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings) and anaemia. Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). The safety of fondaparinux has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) 6 - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 5 mg/0.4 ml, Arixtra 7.5 mg/0.6 ml and Arixtra 10 mg/0.8 ml). These adverse reactions should be interpreted within the surgical or medical context of the indications. The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000). System organ common uncommon rare class (≥ 1/100, <1/10) (≥ 1/1,000, <1/100) (≥ 1/10,000, <1/1,000) MedDRA Infections and post-operative wound infections infestations Blood and anaemia, post- thrombocytopenia, retroperitoneal bleeding*, hepatic, lymphatic system operative thrombocythaemia, intracranial/ intracerebral bleeding* disorders haemorrhage, platelet abnormal, utero-vaginal coagula

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093320 · has-adverse-reaction-information · PDF-Seite 20

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings) and anaemia. Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). The safety of fondaparinux has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 5 mg/0.4 ml, Arixtra 7.5 mg/0.6 ml and Arixtra 10 mg/0.8 ml). These adverse reactions should be interpreted within the surgical or medical context of the indications. The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000). System organ class common uncommon rare MedDRA (≥ 1/100, <1/10) (≥ 1/1,000, <1/100) (≥ 1/10,000, <1/1,000) Infections and post-operative wound infestations infections Blood and lymphatic anaemia, post-operative thrombocytopenia, retroperitoneal bleeding*, system disorders haemorrhage, utero- thrombocythaemia, hepatic, intracranial/ vaginal haemorrhage*, platelet abnormal, in

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093326 · has-adverse-reaction-information · PDF-Seite 33

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings). Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). The safety of fondaparinux has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 5 mg/0.4 ml, Arixtra 7.5 mg/0.6 ml and Arixtra 10 mg/0.8 ml). These adverse reactions should be interpreted within the surgical or medical context of the indications. The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000). 33  System organ class common uncommon rare MedDRA (≥ 1/100, <1/10) (≥ 1/1,000, <1/100) (≥ 1/10,000, <1/1,000) Infections and post-operative wound infestations infections Blood and lymphatic anaemia, post-operative thrombocytopenia, retroperitoneal bleeding*, system disorders haemorrhage, utero- thrombocythaemia, hepatic, int

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093332 · has-adverse-reaction-information · PDF-Seite 45

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings). Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). The safety of fondaparinux has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 5 mg/0.4 ml, Arixtra 7.5 mg/0.6 ml and Arixtra 10 mg/0.8 ml). These adverse reactions should be interpreted within the surgical or medical context of the indications. The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000). 45  System organ class common uncommon rare MedDRA (≥ 1/100, <1/10) (≥ 1/1,000, <1/100) (≥ 1/10,000, <1/1,000) Infections and post-operative wound infestations infections Blood and lymphatic anaemia, post-operative thrombocytopenia, retroperitoneal bleeding*, system disorders haemorrhage, utero- thrombocythaemia, hepatic, int

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093338 · has-adverse-reaction-information · PDF-Seite 57

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings). Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). The safety of fondaparinux has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 1.5 mg/0.3 ml and Arixtra 2.5 mg/0.5 ml) - 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 5 mg/0.4 ml, Arixtra 7.5 mg/0.6 ml and Arixtra 10 mg/0.8 ml) These adverse reactions should be interpreted within the surgical or medical context of the indications. The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000). 57  System organ class common uncommon rare MedDRA (≥ 1/100, <1/10) (≥ 1/1,000, <1/100) (≥ 1/10,000, <1/1,000) Infections and post-operative wound infestations infections Blood and lymphatic anaemia, post-operative thrombocytopenia, retroperitoneal bleeding*, system disorders haemorrhage, utero- thrombocythaemia, hepatic, intr

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093310 · has-contraindication-information · PDF-Seite 4

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.

HOS-093328 · has-contraindication-information · PDF-Seite 43

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.

HOS-093322 · has-contraindication-information · PDF-Seite 31

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.

HOS-093316 · has-contraindication-information · PDF-Seite 17

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.

HOS-093334 · has-contraindication-information · PDF-Seite 55

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.

HOS-093315 · has-indication-information · PDF-Seite 14

Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in adultsfor whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1). Treatment of ST segment elevation myocardial infarction (STEMI) in adults who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis (see sections 4.2 and 5.1).

HOS-093333 · has-indication-information · PDF-Seite 54

Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

HOS-093327 · has-indication-information · PDF-Seite 42

Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

HOS-093309 · has-indication-information · PDF-Seite 2

Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis (see sections 4.2 and 5.1).

HOS-093321 · has-indication-information · PDF-Seite 30

Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

HOS-093336 · has-interaction-information · PDF-Seite 56

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin. Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did 56 not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.

HOS-093330 · has-interaction-information · PDF-Seite 44

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin. 44 Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.

HOS-093312 · has-interaction-information · PDF-Seite 6

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications. Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state. Follow-up therapy with another anticoagulant medicinal product If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection. If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.

HOS-093318 · has-interaction-information · PDF-Seite 19

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications. Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state. Follow-up therapy with another anticoagulant medicinal product If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection. If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.

HOS-093324 · has-interaction-information · PDF-Seite 32

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin. 32 Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.

HOS-093337 · has-pregnancy-information · PDF-Seite 57

Pregnancy No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary. Breast-feeding Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely. Fertility There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.

HOS-093319 · has-pregnancy-information · PDF-Seite 19

Pregnancy There are no adequate data from the use of fondaparinux in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary. Breast-feeding Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely. Fertility There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility. 19

HOS-093325 · has-pregnancy-information · PDF-Seite 33

Pregnancy No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary. Breast-feeding Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely. Fertility There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.

HOS-093331 · has-pregnancy-information · PDF-Seite 45

Pregnancy No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary. Breast-feeding Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely. Fertility There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.

HOS-093313 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no adequate data from the use of fondaparinux in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary. Breast-feeding Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely. Fertility There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.

HOS-093317 · has-warning-information · PDF-Seite 17

Fondaparinux must not be administered intramuscularly. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below. For prevention of VTE- Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary. For treatment of UA/NSTEMI and STEMI-Fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics). For treatment of superficial-vein thrombosis - Fondaparinux should be used with caution in patients who are being treated concomitantly with other medicinal products that increase the risk of haemorrhage. PCI and risk of guiding catheter thrombus In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended. Similarly, in UA/NSTEMI patients with life threatening conditions that require urgent revascularisation, the use of fondaparinux prior to and during PCI is not recommended. These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life- threatening arrhythmias or haemodynamic instability. In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended due to an increased risk of guiding catheter thrombus (see clinical studies section 5.1). Therefore adjunctive UFH should be used during non-primary PCI according to standard practice (see posology in section 4.2). 17 Patients with superficial-vein thrombosis Presence of superficial-vein t

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HOS-093335 · has-warning-information · PDF-Seite 55

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below. As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established. Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co- administration is essential, close monitoring is necessary. Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural anaesthesia in case of surgical procedures should not be used. Elderly patients The elderly population is at increased risk of bleeding. As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 55 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. Fondaparinux should be used with caution in elderly patien

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HOS-093329 · has-warning-information · PDF-Seite 43

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below. As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established. Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co- administration is essential, close monitoring is necessary. Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural anaesthesia in case of surgical procedures should not be used. Elderly patients The elderly population is at increased risk of bleeding. As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 43 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. Fondaparinux should be used with caution in elderly patien

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HOS-093311 · has-warning-information · PDF-Seite 4

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.  For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.  For treatment of superficial-vein thrombosis- Fondaparinux should be used with caution in patients who are being treated concomitantly with other medicinal products that increase the risk of haemorrhage. Patients with superficial-vein thrombosis Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment with fondaparinux. There are no data regarding the use of fondaparinux 2.5 mg in superficial-vein thrombosis patients with concomitant DVT or with superficial-vein thrombosis within 3 cm of the sapheno-femoral junction (see section 4.2 and 5.1). 4 The safety and efficacy of fondaparinux 2.5 mg has not been studied in the following groups: patients with superficial-vein thrombosis following sclerotherapy or resulting as a complication of an intravenous line, patients with history of superficial-vein thrombosis within the previous 3 months, patients with history of venous thromboembolic disease within the previous 6 months, or patients with active cancer (see section 4.2 and 5.1). Spinal / Epidural anaesthe

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HOS-093323 · has-warning-information · PDF-Seite 31

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below. As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established. Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co- administration is essential, close monitoring is necessary. Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural anaesthesia in case of surgical procedures should not be used. Elderly patients The elderly population is at increased risk of bleeding. As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 31 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. Fondaparinux should be used with caution in elderly patien

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