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

arrotex pharmaceuticals pty ltd - bivalirudin, quantity: 250 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - bivalirudin 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). bivalirudin is intended for use with aspirin. a p2y12 antagonist (e.g. clopidogrel or ticlopidine) may be used in addition to aspirin.

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

dr. reddy's laboratories limited - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection 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.  bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see adverse reactions (6.3)]. risk summary there are no data available on use of bivalirudin for injection 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 bir

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

fresenius kabi usa, llc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection 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. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)] . risk summary there are no data available on use of bivalirudin for injection 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 a

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

fresenius kabi usa, llc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection 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. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)] . risk summary there are no data available on use of bivalirudin for injection 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 a

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

apotex corp - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection are 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. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see adverse reactions (6.3)] . risk summary   there are no data available on use of bivalirudin for injection 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 ma

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

sandoz inc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection 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. bivalirudin is contraindicated in patients with: risk summary there are no data available 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 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

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

sandoz inc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin for injection 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. bivalirudin is contraindicated in patients with: risk summary there are no data available 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 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

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

southern xp ip pty ltd - bivalirudin, quantity: 250 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - bivalirudin sxp 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). ,bivalirudin sxp 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)

cipla usa inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection 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. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)]. risk summary there are no data available 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 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 indica

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

hospira, inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin 250 mg - bivalirudin 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. bivalirudin is contraindicated in patients with: risk summary there are no data available 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 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