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)

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