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)

octapharma pharmazeutika produktionsgesellschaft m.b.h. - 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 a von willebrand factor/coagulation factor viii complex (human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von willebrand disease (vwd) as well as patients with mild or moderate vwd in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. clinical trials to evaluate the safety and efficacy of prophylactic dosing with wilate to prevent spontaneous bleeding have not been conducted in vwd subjects. wilate is not indicated for the prevention of excessive bleeding during and after surgery in vwd patients. wilate is not indicated for hemophilia a. wilate is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container. for a complete listing of ingredients, see description ( 11 ). pregnancy category c. animal reproduction studies have not been conducted with wilate. it is also not known whether

Ireland - English - 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

Ireland - English - 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

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

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

octapharma pharmazeutika produktionsges. m.b.h. - human blood coagulation factor viii, human von willebrand factor - powder for solution for i/v injection - 500iu/5ml+ 500iu/5ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

octapharma pharmazeutika produktionsges. m.b.h. - human blood coagulation factor viii, human von willebrand factor - powder for solution for i/v injection - 1000iu/10ml+ 1000iu/10ml

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - factor viii (antihaemophilic factor), von willebrand factor human - pdr+solv for soln for inj - 1000/1000 international unit - blood coagulation factors

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - factor viii (antihaemophilic factor), von willebrand factor human - pdr+solv for soln for inj - 500/500 international unit - blood coagulation factors