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)

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)

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)] .

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

sagent pharmaceuticals - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 10000 [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 suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin) - an uncontrolled active bleeding state [see warnings and precautions (5.4)] , except when this is due to disseminated intravascular coagulation risk summary there are no available data on heparin sodium 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 for the mother and possible risks to the fetus when prescribing heparin sodium to a pregnant woman. if available, preservative-free heparin sodium is recommended when heparin therapy is needed during pregnancy. there are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see warnings and precautions (5.4)]. the 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 to 4% and 15 to 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 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 if available, preservative-free heparin sodium is recommended when heparin therapy is needed during lactation. benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. there is no information regarding the presence of heparin sodium 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 and any potential adverse effects on the breastfed infant from heparin sodium 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)] . carefully examine all heparin sodium vials to confirm choice of the correct strength prior to administration of the drug. pediatric patients, including neonates, have died as a result of medication errors in which heparin sodium vials have been confused with “catheter lock flush” vials [see warnings and precautions (5.1)] . benzyl alcohol toxicity use preservative-free heparin sodium in neonates and infants. serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. 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, particularly women, over 60 years of age [see warnings and precautions (5.2)] . patients over 60 years of age may require lower doses of heparin. lower doses of heparin may be indicated in these patients [see clinical pharmacology (12.3)] .

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

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)

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)

gland pharma limited - 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 re

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)

sagent pharmaceuticals - 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)]; -