Israel - englanti - Ministry of Health

takeda israel ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for injection/infusion - factor viii inhibitor bypassing fraction 1000 u/vial - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - control of bleeding episodes in haemophilia a patients with factor viii inhibitors and also in patients with acquired factor viii inhibitors .control of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available.

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

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2000 iu - injection, diluent for - excipient ingredients: water for injections - biostate is indicated for: - the treatment and prophylaxis of haemorrhage or surgical bleeding in vwd when desmopressin (ddavp) treatment alone is ineffective or contraindicated. - the treatment and prophylaxis of bleeding associated with fviii deficiency due to haemophilia a.

Israel - englanti - Ministry of Health

padagis israel agencies ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 250 iu/vial - coagulation factor viii - coagulation factor viii - for the treatment of classical hemophilia (hemophilia a) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor viii . koate-dvi provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.

Israel - englanti - Ministry of Health

padagis israel agencies ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1000 iu/vial - coagulation factor viii - coagulation factor viii - for the treatment of classical hemophilia (hemophilia a) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor viii . koate-dvi provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.

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

csl behring australia pty ltd - factor viii, quantity: 250 iu; von willebrand factor, quantity: 500 iu - injection, solution - excipient ingredients: water for injections - aleviate is indicated for: ? the treatment of bleeding episodes including surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. ? the treatment and prophylaxis of bleeding associated with factor fviii deficiency due to haemophilia a.

Yhdysvallat - englanti - 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.

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

csl behring australia pty ltd - factor viii -

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

csl behring australia pty ltd - factor viii -

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

csl behring australia pty ltd - factor viii,von willebrand factor -

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

csl behring australia pty ltd - factor viii,von willebrand factor -