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

general injectables and vaccines, inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 reac

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

henry schein, inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 reac

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

phlow corporation - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 ( 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 ( 5.2)] , 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 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 pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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 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 injection is recommended when heparin therapy is needed during lactation. there is no information regarding the presence of heparin sodium 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 breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium injection and any potential adverse effects on the breastfed infant from heparin sodium 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)] . carefully examine all heparin sodium injection 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 injection vials have been confused with “catheter lock flush” vials [see warnings and precautions ( 5.1)] . 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)

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 (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 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 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 use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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 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 injection 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 breastfed infant. there is no information regarding the presence of heparin sodium 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 breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium injection and any potential adverse effects on the breastfed infant from heparin sodium 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)] . carefully examine all heparin sodium injection 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 injection vials have been confused with “catheter lock flush” vials [see warnings and precautions (5.1)] . benzyl alcohol toxicity use preservative-free heparin sodium injection 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)

general injectables & vaccines, inc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium 10000 [usp'u] in 5 ml - heparin sodium is indicated for: atrial fibrillation with embolization: diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and heart surgery; anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; (in a low-dose regimen) for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease (see dosage and administration); prophylaxis and treatment of pulmonary embolism; prophylaxis and treatment of peripheral arterial embolism. heparin sodium should not be used in patients: with severe thrombocytopenia; 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 ne

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

hospira, inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium injection in sodium chloride at a concentration of 2 units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in sodium chloride 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 error! hyperlink reference not valid. ) . 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. the estimated 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. 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 >50 times the human daily dose. 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 in human milk, the effects on the breastfed child, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium in sodium chloride injection and any potential adverse effects on the breastfed child from heparin sodium in sodium chloride injection or from the underlying maternal condition [see use in specific populations (8.4)] . safety and effectiveness in pediatric patients have not been established. a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions (5.1)].

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

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium injection in sodium chloride at a concentration of 2 units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in sodium chloride 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 (5.1)] - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia with thrombosis (hitt) [see warnings and precautions (5.2)] - severe thrombocytopenia [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.5), adverse reactions (6.1)] 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 increas

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

fresenius kabi norge as - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium injection in sodium chloride at a concentration of 2 units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in sodium chloride 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 (5.1)] - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia with thrombosis (hitt) [see warnings and precautions (5.2)] - severe thrombocytopenia [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.5), adverse reactions (6.1)] 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 increas

Ireland - English - HPRA (Health Products Regulatory Authority)

cp pharmaceuticals ltd trading as wockhardt uk - heparin sodium - solution for injection - 25000 iu/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

cp pharmaceuticals ltd trading as wockhardt uk - heparin sodium - solution for injection - 25000 iu/ml