Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - dried factor viii fraction 250 [iu]; von willebrand's factor : ristocetin cofactor 500 [iu] - injection with diluent - 250 iu - active: dried factor viii fraction 250 [iu] von willebrand's factor : ristocetin cofactor 500 [iu] excipient: albumin calcium chloride dihydrate plasma protein sodium chloride sodium citrate dihydrate sucrose trometamol water for injection - biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - dried factor viii fraction 500 [iu]; von willebrand's factor : ristocetin cofactor 1000 [iu] - injection with diluent - 500 iu - active: dried factor viii fraction 500 [iu] von willebrand's factor : ristocetin cofactor 1000 [iu] excipient: albumin calcium chloride dihydrate plasma protein sodium chloride sodium citrate dihydrate sucrose trometamol water for injection - biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated

Singapúr - enska - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - antihemophilic factor (human) (factor viii) - injection, powder, for solution - min 800 iu/10 ml - antihemophilic factor (human) (factor viii) min 800 iu/10 ml

Singapúr - enska - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - antihemophilic factor (human) (factor viii) - injection, powder, for solution - min 250 iu/5 ml - antihemophilic factor (human) (factor viii) min 250 iu/5 ml

Singapúr - enska - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - antihemophilic factor (human) (factor viii) - injection, powder, for solution - min 400 iu/5 ml - antihemophilic factor (human) (factor viii) min 400 iu/5 ml

Malta - enska - 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 - enska - 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 - enska - 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 - enska - Medicines Authority

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

Bandaríkin - enska - NLM (National Library of Medicine)

wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is no informa