European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human coagulation factor viii, human von willebrand factor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand disease (vwd)prophylaxis and treatment of haemorrhage or surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated.haemophilia a (congenital factor-viii deficiency)prophylaxis and treatment of bleeding in patients with haemophilia a.

Malta - English - Medicines Authority

bpl bioproducts laboratory gmbh dornhofstraße 34, 63263 neu-isenburg,, germany - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 250 iu von willebrand factor, human 430 iu - antihemorrhagics

Malta - English - Medicines Authority

bpl bioproducts laboratory gmbh dornhofstraße 34, 63263 neu-isenburg,, germany - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 500 iu von willebrand factor, human 860 iu - antihemorrhagics

Malta - English - Medicines Authority

bpl bioproducts laboratory gmbh dornhofstraße 34, 63263 neu-isenburg,, germany - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 1000 iu von willebrand factor, human 1720 iu - antihemorrhagics

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu human coagulation factor viii 500 iu - antihemorrhagics

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor xiii - powder and solvent for solution for injection - human von willebrand factor 1000 iu human coagulation factor viii 1000 iu - antihemorrhagics

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - factor viii, human recombinant - pdr+solv for soln for inj - 500 iu international unit

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

de soutter medical australia pty ltd - 37251 - drill, surgical, system - devices made up of a power hand piece and a variety of attachments including drill bits, burs and saw blades. the system may be powered by, e.g. air, nitrogen or a battery. this flexible configuration allows the system to be used in a number of different surgical procedures.

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate 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). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.