New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 1500 [iu];   - powder for infusion - 1500 iu - active: efmoroctocog alfa 1500 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 2000 [iu];   - powder for infusion - 2000 iu - active: efmoroctocog alfa 2000 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 250 [iu];   - powder for infusion - 250 iu - active: efmoroctocog alfa 250 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 3000 [iu];   - powder for infusion - 3000 iu - active: efmoroctocog alfa 3000 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 500 [iu];   - powder for infusion - 500 iu - active: efmoroctocog alfa 500 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 750 [iu];   - powder for infusion - 750 iu - active: efmoroctocog alfa 750 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - Tiếng Anh - 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)

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bioverativ therapeutics inc. - sutimlimab (unii: gnwe7kj995) (sutimlimab - unii:gnwe7kj995) - cold agglutinin disease enjaymo (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (cad). enjaymo is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see warnings and precautions (5.2) and adverse reactions (6.1)] . risk summary there are no available data on enjaymo use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. human immunoglobulin g (igg) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus. in animal reproduction studies, intravenous administration of sutimlimab-jome to pregnant monkeys during organogenesis at doses 2 to 3 times the maximum recommended human doses did not result in adverse effects on pregnancy or offspring development (see

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bioverativ therapeutics inc. - efmoroctocog alfa (unii: 7pcm518ylr) (efmoroctocog alfa - 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) 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 its excipients (sucrose, sodium chloride, l-histidine, calcium chloride and polysorbate 20). 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 pregnanci

Hoa Kỳ - Tiếng Anh - 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