Singapur - engleski - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - antihemophilic factor (recombinant) sucrose formulated - injection, powder, lyophilized, for solution - 500iu/vial - antihemophilic factor (recombinant) sucrose formulated 500iu/vial

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

csl behring llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - helixate® fs is a recombinant antihemophilic factor indicated for: helixate fs is not indicated for the treatment of von willebrand disease. helixate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). pregnancy category c animal reproduction studies have not been conducted with helixate fs. it is also not known whether helixate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. helixate fs should be given to a pregnant woman only if clearly needed. there is no information available on the effect of factor viii replacement therapy on labor and delivery. helixate fs should be used only if clinically needed. it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, caution sho

Australija - engleski - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - factor viii inhibitor bypassing fraction -

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 1000 u;  ;   - powder for injection with diluent - 1000 u - active: factor viii inhibitor bypassing fraction 1000 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 2500 u;  ;   - powder for injection with diluent - 2500 u - active: factor viii inhibitor bypassing fraction 2500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 500 u;  ;   - powder for injection with diluent - 500 u - active: factor viii inhibitor bypassing fraction 500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Singapur - engleski - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 1000iu/vial - moroctocog alfa (af-cc) 1000iu/vial

Singapur - engleski - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 2000iu/vial - moroctocog alfa (af-cc) 2000iu/vial

Singapur - engleski - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 250iu/vial - moroctocog alfa (af-cc) 250iu/vial