Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - eftrenonacog alfa - powder and solvent for solution for injection - 2000unit

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - eftrenonacog alfa - powder and solvent for solution for injection - 3000unit

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 1000 [iu];   - powder for infusion - 1000 iu - active: eftrenonacog alfa 1000 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 2000 [iu];   - powder for infusion - 2000 iu - active: eftrenonacog alfa 2000 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 250 [iu];   - powder for infusion - 250 iu - active: eftrenonacog alfa 250 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 3000 [iu];   - powder for infusion - 3000 iu - active: eftrenonacog alfa 3000 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 500 [iu];   - powder for infusion - 500 iu - active: eftrenonacog alfa 500 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

Estats Units - anglès - 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

Estats Units - anglès - 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

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 4000 [iu];   - powder for infusion - 4000 iu - active: eftrenonacog alfa 4000 [iu]   excipient: histidine hydrochloric acid mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)