Australia - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Panama - engelsk - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

takeda manufacturing austria ag - factor vii - factor vii....600 ui / agua inyectable....10 ml

Malta - engelsk - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 250 iu; von willebrand factor, human 430 iu - antihemorrhagics

Malta - engelsk - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 500 iu; von willebrand factor, human 860 iu - antihemorrhagics

Malta - engelsk - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 1000 iu; von willebrand factor, human 1720 iu - antihemorrhagics

Malta - engelsk - Medicines Authority

bio products laboratory limited - factor ix, human - powder for solution for injection - factor ix, human 50 international unit(s)/millilitre - antihemorrhagics

USA - engelsk - NLM (National Library of Medicine)

kedrion biopharma, inc. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk) - antihemophilic factor human 250 [iu] in 5 ml - koĀte® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia a (hereditary factor viii deficiency). limitation of use koĀte is not indicated for the treatment of von willebrand disease. koĀte is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to koĀte or its components. [see description (11) ] risk summary there are no data with koĀte use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using koĀte. it is not known whether koĀte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. koĀte should be given to a pregnant woman only if clearly needed. 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. risk summary there is no information regarding the presence of koĀte in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for koĀte and any potential adverse effects on the breast-fed infant from koĀte or from the underlying maternal condition. safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. subjects received 208 infusions of koĀte for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis.  children have shorter half-life and lower recovery of factor viii than adults. because clearance of factor viii (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. clinical studies of koĀte did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. individualize dose selection for geriatric patients.

USA - engelsk - NLM (National Library of Medicine)

kedrion biopharma, inc. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk) - antihemophilic factor human 250 [iu] in 5 ml - koĀte® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia a (hereditary factor viii deficiency). limitation of use koĀte is not indicated for the treatment of von willebrand disease. koĀte is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to koĀte or its components. [see description (11) ] risk summary there are no data with koĀte use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using koĀte. it is not known whether koĀte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. koĀte should be given to a pregnant woman only if clearly needed. 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. risk summary there is no information regarding the presence of koĀte in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for koĀte and any potential adverse effects on the breast-fed infant from koĀte or from the underlying maternal condition. safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. subjects received 208 infusions of koĀte for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis. children have shorter half-life and lower recovery of factor viii than adults. because clearance of factor viii (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. clinical studies of koĀte did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. individualize dose selection for geriatric patients.