Canada - English - Health Canada

b. braun medical inc - heparin sodium; dextrose - solution - 10000unit; 5g - heparin sodium 10000unit; dextrose 5g - heparins

Canada - English - Health Canada

b. braun medical inc - dextrose; heparin sodium - solution - 5g; 4000unit - dextrose 5g; heparin sodium 4000unit - heparins

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)

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)] .

Canada - English - Health Canada

baxter corporation - heparin sodium; dextrose - solution - 5000unit; 5g - heparin sodium 5000unit; dextrose 5g - heparins

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

Israel - English - Ministry of Health

pharmalogic ltd - heparin sodium - solution for injection / infusion - heparin sodium 5000 iu/ml - heparin - heparin - • prevention of thromboembolic disorders• as part of the treatment of venous or arterial thromboembolic disorders (including the early treatment of heart attacks as well as unstable angina pectoris)• for anticoagulation during treatment or operation with an extracorporeal circulation (e.g. heart/lung machine, hemodialysis)

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ain medicare sdn. bhd. - heparin sodium -

Canada - English - Health Canada

fresenius kabi canada ltd - heparin sodium - solution - 10000unit - heparin sodium 10000unit - heparins