Singapore - English - HSA (Health Sciences Authority)

wellchem pharmaceuticals pte ltd - coagulation factor viii (human) - injection, powder, for solution - 500 iu/10 ml - coagulation factor viii (human) 500 iu/10 ml vial

Singapore - English - 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

Singapore - English - 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

Singapore - English - 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

United States - English - NLM (National Library of Medicine)

octapharma usa inc - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk), von willebrand factor human (unii: ze22ne22f1) (von willebrand factor human - unii:ze22ne22f1) - antihemophilic factor human 100 [iu] in 1 ml - wilate is indicated in children and adults with von willebrand disease for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding wilate is indicated in adolescents and adults with hemophilia a for: - routine prophylaxis to reduce the frequency of bleeding episodes - on-demand treatment and control of bleeding episodes wilate is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation [see description (11) ] , or components of the container. risk summary there are no data with wilate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with wilate. wilate was given to four subjects (3 type 3 and 1 type 2b) during labor and delivery in one clinical study. two subjects underwent vaginal delivery (type 3) and two subjects had a cesarean section (type 3/type 2b). in this study all pro

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 25 [iu] in 1 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand’s disease. recombinate is contraindicated in patients w

Ireland - English - HPRA (Health Products Regulatory Authority)

csl behring gmbh - factor viii (antihaemophilic factor) von willebrand factor - pdr+solv for soln for inj - 500iu vial international unit

Ireland - English - HPRA (Health Products Regulatory Authority)

csl behring gmbh - factor viii (antihaemophilic factor) von willebrand factor - solution for infusion - 1000iu via international unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

500unit) powder and 20ml solvent for solution for infusion vials (takeda uk ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for infusion - 500unit

India - English - Central Drugs Standard Control Organization

reliance life - dried factor viii fraction - vial - vial