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

bayer australia ltd - damoctocog alfa pegol, quantity: 1000 iu - injection, powder for - excipient ingredients: polysorbate 80; calcium chloride dihydrate; glycine; sodium chloride; sucrose; histidine - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 2000 iu - injection, powder for - excipient ingredients: glycine; histidine; sucrose; calcium chloride dihydrate; sodium chloride; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; sucrose; glycine; calcium chloride dihydrate; histidine; sodium chloride - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 3000 iu - injection, powder for - excipient ingredients: calcium chloride dihydrate; sucrose; sodium chloride; glycine; histidine; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; calcium chloride dihydrate; polysorbate 80; glycine; sodium chloride; histidine - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

European Union - English - EMA (European Medicines Agency)

bayer ag - damoctocog alfa pegol - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia a (congenital factor viii deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - damoctocog alfa pegol 1000 [iu] - powder for injection with diluent - 1000 iu - active: damoctocog alfa pegol 1000 [iu] excipient: calcium chloride dihydrate glacial acetic acid glycine histidine polysorbate 80 sodium chloride sucrose water for injection - treatment and prophylaxis of bleeding in previously treated patients (ptps) not less than 12 years of age with haemophilia a (congenital factor viii deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - damoctocog alfa pegol 2000 [iu] - powder for injection with diluent - 2000 iu - active: damoctocog alfa pegol 2000 [iu] excipient: calcium chloride dihydrate glacial acetic acid glycine histidine polysorbate 80 sodium chloride sucrose water for injection - treatment and prophylaxis of bleeding in previously treated patients (ptps) not less than 12 years of age with haemophilia a (congenital factor viii deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - damoctocog alfa pegol 250 [iu] - powder for injection with diluent - 250 iu - active: damoctocog alfa pegol 250 [iu] excipient: calcium chloride dihydrate glacial acetic acid glycine histidine polysorbate 80 sodium chloride sucrose water for injection - treatment and prophylaxis of bleeding in previously treated patients (ptps) not less than 12 years of age with haemophilia a (congenital factor viii deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - damoctocog alfa pegol 3000 [iu] - powder for injection with diluent - 3000 iu - active: damoctocog alfa pegol 3000 [iu] excipient: calcium chloride dihydrate glacial acetic acid glycine histidine polysorbate 80 sodium chloride sucrose water for injection - treatment and prophylaxis of bleeding in previously treated patients (ptps) not less than 12 years of age with haemophilia a (congenital factor viii deficiency).