Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 2000 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 250 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 500 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

wyeth farma s.a. - nonacog alfa - powder and solvent for solution for injection - 250iu

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

wyeth farma s.a. - nonacog alfa - powder and solvent for solution for injection - 500iu

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

wyeth farma s.a. - nonacog alfa - powder and solvent for solution for injection - 1000iu

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

wyeth farma s.a. - nonacog alfa - powder and solvent for solution for injection - 2000iu

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

csl behring lengnau ag - albutrepenonacog alfa (unii: a57kx1vl5p) (albutrepenonacog alfa - unii:a57kx1vl5p) - albutrepenonacog alfa 250 [iu] in 2.5 ml - idelvion® , coagulation factor ix (recombinant), albumin fusion protein (rix-fp), a recombinant dna-derived coagulation factor ix concentrate, is indicated in children and adults with hemophilia b (congenital factor ix deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes limitations of use: idelvion is not indicated for immune tolerance induction in patients with hemophilia b. idelvion is contraindicated in patients who have had life-threatening hypersensitivity reactions to idelvion, or its components, including hamster proteins [see warnings and precautions (5.1)] . risk summary there are no data with idelvion use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using idelvion. it is not known whether idelvion can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. in the u.s. general populati

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

biogen inc. - eftrenonacog alfa (unii: 02e00t2qde) (eftrenonacog alfa - unii:02e00t2qde) - eftrenonacog alfa 500 [iu] in 5 ml - alprolix, coagulation factor ix (recombinant), fc fusion protein, is a recombinant dna derived, coagulation factor ix concentrate indicated in adults and children with hemophilia b (congenital factor ix 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 alprolix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)]. alprolix is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients (sucrose, mannitol, sodium chloride, l-histidine and polysorbate 20) . . pregnancy category c animal reproductive studies have not been conducted with alprolix. it is also not known whether alprolix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. alprolix should be given to a pregnant woma

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

bioverativ therapeutics inc. - eftrenonacog alfa (unii: 02e00t2qde) (eftrenonacog alfa - unii:02e00t2qde) - eftrenonacog alfa 500 [iu] in 5 ml - alprolix, coagulation factor ix (recombinant), fc fusion protein, is a recombinant dna derived coagulation factor ix concentrate indicated in adults and children with hemophilia b (congenital factor ix 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: alprolix is not indicated for induction of immune tolerance in patients with hemophilia b. alprolix is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients (sucrose, mannitol, sodium chloride, l-histidine and polysorbate 20). risk summary there are no studies of alprolix use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2%–4% and of misca