Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 1000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 2000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 250 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 500 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

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

wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is no informa

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

novo nordisk - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - coagulation factor viia recombinant human 1 mg in 1 ml - novoseven rt, coagulation factor viia (recombinant), is indicated for: none known. risk summary there are no adequate and well-controlled studies using novoseven rt in pregnant women to determine whether there is a drug-associated risk. treatment of rats and rabbits with novoseven in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. at 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. twenty-three out of 25 female rats given 6 mg per kg body weight of novoseven gave birth successfully, however, two of the 23 litters died during the early period of lactation. no evidence of teratogenicity was observed after dosing with novoseven. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is

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

aptevo biotherapeutics llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated for the treatment of: - adults and children ≥ 12 years of age with hemophilia b for: on-demand treatment and control of bleeding episodes perioperative management - on-demand treatment and control of bleeding episodes - perioperative management - adults with hemophilia b for: routine prophylaxis to reduce the frequency of bleeding episodes - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated b

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

takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

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

novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no informati

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

biogen inc. - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) (unii: 7pcm518ylr) ((1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) - unii:7pcm51 - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or other constituents of the product. [see description (11 )] risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. animal reproductive and devel