Canada - English - Health Canada

dr reddy's laboratories ltd - bivalirudin - powder for solution - 250mg - bivalirudin 250mg - direct thrombin inhibitors

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - bivalirudin -

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - bivalirudin -

United States - English - NLM (National Library of Medicine)

maia pharmaceuticals, inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - angiomax rtu is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (pci), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. angiomax rtu is contraindicated in patients with: - significant active bleeding; - hypersensitivity to angiomax rtu or its components [see adverse reactions (6.2)] . risk summary there are no available data on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously (sc) doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) based on body surface area (bsa), respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the

United States - English - NLM (National Library of Medicine)

cardinal health - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - bivalirudin 250 mg - powder for concentrate for solution for injection/infusion - 250 mg - bivalirudin 250 mg - bivalirudin

Australia - English - Department of Health (Therapeutic Goods Administration)

sciclone pharmaceuticals pty ltd - bivalirudin, quantity: 250 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol - angiomax is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (pci). angiomax is intended for use with aspirin.,angiomax is indicated for use as an anticoagulant: in the treatment of patients with moderate to high risk acute coronary syndromes (acs) [unstable angina/non-st segment elevation myocardial infarction (ua/nstemi) who are undergoing early invasive management, and in patients undergoing percutaneous coronary intervention (pci). angiomax is intended for use with aspirin. a p2y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin injection is an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin injection is contraindicated in patients with: risk summary there are no available data on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously (sc) doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clini

United States - English - NLM (National Library of Medicine)

sandoz inc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - angiomax is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. angiomax is contraindicated in patients with: risk summary there are no data available on use of angiomax in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recogniz

European Union - English - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - acute coronary syndrome - antithrombotic agents - angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (pci), including patients with st-segment-elevation myocardial infarction (stemi) undergoing primary pci.angiox is also indicated for the treatment of adult patients with unstable angina / non-st-segment-elevation myocardial infarction (ua / nstemi) planned for urgent or early intervention.angiox should be administered with aspirin and clopidogrel.