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sandoz inc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 1 ml - heparin sodium injection is indicated for: the use of heparin sodium injection is contraindicated in patients with the following conditions: risk summary there are no available data on heparin sodium injection use in pregnant women to inform a drug- associated risk of major birth defects and miscarriage. in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (mrhd) of 45,000 units/ day (see data) . consider the benefits and risks of heparin sodium injection for the mother and possible risks to the fetus when prescribing heparin sodium injection to a pregnant woman. if available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during pr

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

hikma pharmaceuticals usa inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 1000 [usp'u] in 1 ml - heparin sodium injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism; - prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism. - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see warnings and precautions (5.3)] ; - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions

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

b. braun medical inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - heparin 4000 [usp'u] in 100 ml - heparin sodium in 5% dextrose injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation - treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation) - prevention of clotting in arterial and cardiac surgery - prophylaxis and treatment of peripheral arterial embolism - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.7) and adverse reactions (6.1)] - in whom suitable blood coagulation tests – e.g., the whole blood clotti

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

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 100 ml - heparin sodium is indicated for: - prophylaxis and treatment of venous thromboembolism and pulmonary embolism; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism; - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions (6.1)] - in whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thro

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

sagent pharmaceticals - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 1000 [usp'u] in 1 ml - heparin sodium injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism - prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease - atrial fibrillation with embolization - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) - prevention of clotting in arterial and cardiac surgery - prophylaxis and treatment of peripheral arterial embolism - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures the use of heparin sodium is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions (6.1)] - in whom su

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

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 1 ml - heparin sodium injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism; - prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism. - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see warnings and precautions (5.3)] ; - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions

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

safecor health, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 1 ml - heparin sodium injection, usp is indicated for: anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see dosage and administration ); prophylaxis and treatment of pulmonary embolism; atrial fibrillation with embolization; treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism. heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures. heparin sodium should not be used in patients with the following conditions: severe thrombocytopenia; when suitable blood coagulation tests, e.g., the whole b

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

baxter healthcare corporation - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 200 [usp'u] in 100 ml - heparin sodium in sodium chloride injection at a concentration of 2 units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in sodium chloride injection is contraindicated in patients with the following conditions: risk summary there are no available data on heparin sodium in sodium chloride injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in published reports heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans (see data) . consider the benefits and risks of heparin sodium in sodium chloride injection for the mother and possible risks to the fetus when prescribing heparin sodium in sodium chloride injection to a pregnant woman. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. however, the background ris

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

hospira, inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 10000 [usp'u] in 100 ml - heparin sodium in 5% dextrose injection is indicated for: the use of heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: risk summary in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses up to 10,000 usp units/kg/day, approximately 10 times the maximum recommended human dose (mrhd) of 40,000 usp units/24 hours infusion [see data] . in pregnant animals, doses up to 10 times higher than the maximum human daily dose based on body weight resulted in increased resorptions. consider the benefits and risks of heparin sodium in 5% dextrose injection to a pregnant woman and possible risks to the fetus when prescribing heparin sodium in 5% dextrose injection. 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 recognized pregnancies is 2–4% and 15–20%, respectively. data human data the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. animal data in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 usp units/kg/day, approximately 10 times the maximum human daily dose based on body weight. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. risk summary there is no information regarding the presence of heparin sodium in 5% dextrose injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium in 5% dextrose injection and any potential adverse effects on the breastfed infant from heparin sodium in 5% dextrose injection or from the underlying maternal condition [see use in specific populations (8.4)] . there are no adequate and well controlled studies on heparin use in pediatric patients. pediatric dosing recommendations are based on clinical experience [see dosage and administration (2.4)] . there are limited adequate and well-controlled studies in patients 65 years and older. however, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions (5.2)] . lower doses of heparin may be indicated in these patients [see clinical pharmacology (12.3)] .

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

b. braun medical inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 200 [usp'u] in 100 ml - heparin sodium in 0.9% sodium chloride injection at the concentration of 2 usp units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in 0.9% sodium chloride injection is contraindicated in patients with the following conditions: - uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation [see warnings and precautions (5.2)] - history of heparin-induced thrombocytopenia (hit) or heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - severe thrombocytopenia [see warnings and precautions (5.3, 5.4)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.5) and adverse reactions (6.1)] in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses, approximately 2777 times the recommended human dose (mrhd) for maintenance of catheter patency of heparin [see data] . in pregnant animals, doses up to 2777 times higher than the human daily dose of heparin resulted in increased resorptions. consider the benefits and risks of heparin sodium in 0.9% sodium chloride injection to a pregnant woman and possible risks to the fetus when prescribing heparin sodium in 0.9% sodium chloride injection. 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 recognized pregnancies is 2-4% and 15-20%, respectively. the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 usp units/kg/day, approximately 2777 times the human daily dose. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. there is no information regarding the presence of heparin sodium in 0.9% sodium chloride injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for heparin sodium in 0.9% sodium chloride injection and any potential adverse effects on the breastfed infant from heparin sodium in 0.9% sodium chloride injection or from the underlying maternal condition [see use in specific populations (8.4)] . there are no adequate and well controlled studies on heparin use in pediatric patients. there are limited adequate and well-controlled studies in patients 65 years and older. however, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions (5.2)] .