Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 8

HOS-136915 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 39

HOS-136956 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 70

HOS-136990 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 101

HOS-137024 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 132

HOS-137058 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 163

HOS-137091 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 189

HOS-137127 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930)

Gegenanzeigen · Inhixa

Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose container · Abschnitt 4.3 · PDF-Seite 216

HOS-137161 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930) benzyl alcohol (HOS-109798)

Gegenanzeigen · Inhixa

Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose container · Abschnitt 4.3 · PDF-Seite 239

HOS-137196 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930) benzyl alcohol (HOS-109798)

Gegenanzeigen · Inhixa

Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose container · Abschnitt 4.3 · PDF-Seite 262

HOS-137230 · Präparat HOS-097950

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): heparin (HOS-086930) benzyl alcohol (HOS-109798)

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 11

HOS-136916 · Präparat HOS-097950

Concomitant use not recommended

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 11

HOS-136917 · Präparat HOS-097950

Medicinal products affecting haemostasis (see section 4.4)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 11

HOS-136918 · Präparat HOS-097950

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,

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sodium (HOS-109681) ketorolac (HOS-136919)

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 11–12

HOS-136920 · Präparat HOS-097950

11  - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): reteplase (HOS-136922) streptokinase (HOS-135121) alteplase (HOS-136921) tenecteplase (HOS-091171) urokinase (HOS-136923)

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 12

HOS-136924 · Präparat HOS-097950

Concomitant use with caution

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 12

HOS-136925 · Präparat HOS-097950

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dextran 40 (HOS-136927) clopidogrel (HOS-087927) ticlopidine (HOS-087946)

Wechselwirkungen · Inhixa

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 12

HOS-136928 · Präparat HOS-097950

• 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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sodium (HOS-109681) potassium (HOS-086929)

Wechselwirkungen · Inhixa

Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 42

HOS-136957 · Präparat HOS-097950

Concomitant use not recommended

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Inhixa

Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 42

HOS-136958 · Präparat HOS-097950

Medicinal products affecting haemostasis (see section 4.4)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Inhixa

Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 42

HOS-136959 · Präparat HOS-097950

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:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sodium (HOS-109681)