Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - nadroparin calcium, quantity: 3800 anti-xa iu - injection, solution - excipient ingredients: calcium hydroxide; water for injections - prophylaxis against deep vein thrombosis (dvt) associated with general or orthopaedic surgery. treatment of dvt. prevention of clotting during haemodialysis. prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - nadroparin calcium, quantity: 2850 anti-xa iu - injection, solution - excipient ingredients: calcium hydroxide; water for injections - prophylaxis against deep vein thrombosis (dvt) associated with general or orthopaedic surgery. treatment of dvt. prevention of clotting during haemodialysis. prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - nadroparin calcium, quantity: 1900 anti-xa iu - injection, solution - excipient ingredients: calcium hydroxide; water for injections - prophylaxis against deep vein thrombosis (dvt) associated with general or orthopaedic surgery. treatment of dvt. prevention of clotting during haemodialysis. prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

Malta - angleščina - Medicines Authority

pinewood laboratories limited ballymacarbry, clonmel, co. tipperary, ireland - heparin sodium - solution for injection concentrate for solution for infusion - heparin sodium 1000 iu/ml - antithrombotic agents

Kanada - angleščina - Health Canada

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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

hospira, inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 10000 [usp'u] in 100 ml - heparin sodium in sodium chloride injection is indicated for: the use of heparin sodium is contraindicated in patients: 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. 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 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) . consider the benefits and risks of heparin sodium in sodium chloride injection to a pregnant woman 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 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 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 sodium chloride injection 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, and any heparin in milk would not be orally absorbed by a nursing child. 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)] . 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)] . 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)] .

Združene države Amerike - angleščina - 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)] .

Južnoafriška republika - angleščina - South African Health Products Regulatory Authority (SAHPRA)

b braun medical (pty) ltd - injection - each 0,5 ml solution contains heparin calcium 5 000 iu

Izrael - angleščina - 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)

Malta - angleščina - Medicines Authority

wockhardt uk limited - heparin sodium - solution for infusion or injection - heparin sodium 1000 iu/ml - antithrombotic agents