Irska - angleščina - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - factor viii, human recombinant - pdr+solv for soln for inj - 500 iu international unit

Združene države Amerike - angleščina - 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.

Združene države Amerike - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

csl limited - factor viii -

Malta - angleščina - Malta Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - factor viii, human - powder and solvent for solution for infusion - factor viii, human 1000 iu - antihemorrhagics

Malta - angleščina - Malta Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu - antihemorrhagics

Malta - angleščina - Malta Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu/ml - antihemorrhagics

Malta - angleščina - Malta Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 100 iu/ml - antihemorrhagics

Malta - angleščina - Malta Medicines Authority

octapharma (ip) limited - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu/ml - antihemorrhagics

Malta - angleščina - Malta Medicines Authority

octapharma (ip) limited - factor viii, human - powder and solvent for solution for injection - factor viii, human 100 iu/ml - antihemorrhagics