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dr. reddy's laboratories inc. - fondaparinux sodium (unii: x0q6n9usoz) (fondaparinux - unii:j177fow5jl) - fondaparinux sodium 2.5 mg in 0.5 ml - fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. fondaparinux sodium injection is contraindicated in the following conditions: - severe renal impairment (creatinine clearance [crcl] <30 ml/min). [see warnings and precautions (5.3) and use in specific populations (8.6)] - active major bleeding. - bacterial endocarditis

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cardinal health - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 100 mg in 1 ml - enoxaparin sodium injection, usp is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): enoxaparin sodium injection, usp is indicated for: enoxaparin sodium injection, usp is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently administered with aspirin. enoxaparin sodium injection, usp, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute st-segment elevation myocardial infarction (stemi) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (pci). enoxaparin sodium injection is contraindicated in patients with: risk summary placental transfer of enoxaparin was observed in the animal studies. human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of maj

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pfizer laboratories div pfizer 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; - 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 injection is contraindicated in patients: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis - history of thrombocytopenia with pentosan polysulfate - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions (6.1)] - in whom suitable blood coagulation tests (e.g., whole-blood clotting time, partial thromboplastin time) cannot be performed at appropriate inter

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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

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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)] .

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amphastar pharmaceuticals, inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 100 mg in 1 ml - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently adminis

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teva parenteral medicines, inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 30 mg in 0.3 ml - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently admin

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

fresenius kabi usa, llc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 100 mg in 1 ml - enoxaparin sodium is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium enoxaparin sodium is indicated for the prophylaxis of ischemic complications of unstable angina and non–q-wave myocardial infarction, when concurrently administered with aspirin. enoxapari

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

sandoz inc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 100 mg in 1 ml - enoxaparin sodium injection, usp is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): enoxaparin sodium injection, usp is indicated for: enoxaparin sodium injection, usp is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently administered with aspirin. enoxaparin sodium injection, usp, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute st-segment elevation myocardial infarction (stemi) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (pci). enoxaparin sodium injection is contraindicated in patients with: risk summary placental transfer of enoxaparin was observed in the animal studies. human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of maj