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

general injectables & vaccines, inc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium injection 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 fibrilation with embolization; diagnosis and 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 and in blood samples for laboratory purposes. heparin sodium should not be used in patients with the following conditions: severe thrombocytopenia; when suitable blood coagulation tests, e.g.,

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - heparin sodium 1000 iu/ml;   - solution for injection - 1000 iu/ml - active: heparin sodium 1000 iu/ml  

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - heparin sodium 1000 iu/ml - solution for injection - 1000 iu/ml - active: heparin sodium 1000 iu/ml excipient: benzyl alcohol methyl hydroxybenzoate propyl hydroxybenzoate sodium chloride sodium citrate dihydrate water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacia limited company trading as pharmacia - heparin sodium 1000 u/ml - solution for injection - 5000 u/5ml - active: heparin sodium 1000 u/ml excipient: water for injection

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

pfizer (perth) pty ltd - heparin sodium, quantity: 1000 iu/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism, coronary or venous thrombosis and occlusive vascular disease. as a low-dose regimen for the prevention of thromboembolic complications arising as a result of cardiac and arterial surgery. as an anticoagulant during blood transfusions, extracorporeal circulation, dialysis and other perfusion techniques and in blood samples for laboratory purposes.

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

baxter healthcare corporation - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 1000 [iu] in 500 ml

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

mylan institutional llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 preg

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

mylan institutional llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 preg

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

cardinal health 107, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - 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 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 2-4% 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 nursing 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 nursing 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 (2.5) ]. carefully examine all heparin sodium injection vials and syringes 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) ].

Israel - English - Ministry of Health

teva israel ltd - heparin sodium - solution for injection / infusion - heparin sodium 25000 iu / 5 ml - heparin - - prevention of thromboembolic disorders.- as part of the treatment of venous and arterial thromboembolic disorders (including early treatment of heart attacks as well as unstable angina pectoris)- for the anticoagulation in case of treatment or operation with extracorporeal circulation (e.g. heart-lung machine, hemodialysis)