Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 2000 [iu] (recombinant factor viii) - injection with diluent - 2000 iu - active: octocog alfa 2000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 3000 [iu] (recombinant factor viii) - injection with diluent - 3000 iu - active: octocog alfa 3000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only

Malta - angleščina - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor viii, inhibitor bypassing, fraction - powder and solvent for solution for infusion - factor viii inhibitor bypassing fraction 25 u/ml - antihemorrhagics

Irska - angleščina - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 500/500 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

Irska - angleščina - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 1000/1000 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

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

csl behring australia pty ltd - factor ix, quantity: 50 iu/ml - injection, diluent for - excipient ingredients: water for injections - "tbsf" high purity factor ix concentrate is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. "tbsf" high purity factor ix concentrate is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. "tbsf" high purity factor ix concentrate is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

Irska - angleščina - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - factor viii, human recombinant - pdr+solv for soln for inj - 250 iu international unit