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

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2400 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

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

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

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

grifols usa, llc - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 250 [iu] in 5 ml - alphanate, (antihemophilic factor/von willebrand factor complex [human]), is indicated for: - control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor viii (fviii) deficiency due to hemophilia a. - surgical and/or invasive procedures in adult and pediatric patients with von willebrand disease (vwd) in whom desmopressin (ddavp) is either ineffective or contraindicated.  it is not indicated for patients with severe vwd (type 3) undergoing major surgery. alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components [see adverse reactions (6) ]. pregnancy category c.  animal reproduction studies have not been conducted with alphanate.  it is also not known whether alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.  alphanate should be given to a pregnant woman only if clearly needed.   no human o

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

takeda pharmaceuticals america, inc. - von willebrand factor human (unii: ze22ne22f1) (von willebrand factor human - unii:ze22ne22f1) - von willebrand factor human 650 [iu] in 5 ml - vonvendi [von willebrand factor (recombinant)] is a recombinant von willebrand factor (rvwf) indicated for use in adults (age 18 and older) diagnosed with von willebrand disease (vwd) for: - on-demand treatment and control of bleeding episodes. - perioperative management of bleeding. - routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe type 3 vwd receiving on-demand therapy. vonvendi is contraindicated in patients who have had life-threatening hypersensitivity reactions to vonvendi or constituents of the product (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins) [see description (11)] . risk summary adequate and well-controlled studies with vonvendi have not been conducted in pregnant women. animal developmental and reproductive toxicity studies have not been conducted with vonvendi. it is not known whether vonvendi can cause fetal harm when administered to a pregnant woman or whether it can affect reprodu

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

csl behring gmbh - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 80 [iu] in 1 ml - humate-p, antihemophilic factor/von willebrand factor complex (human), is indicated for treatment and prevention of bleeding in adults with hemophilia a (classical hemophilia). humate-p is also indicated in adult and pediatric patients with von willebrand disease (vwd) for: controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with humate-p to prevent spontaneous bleeding have not been conducted in vwd subjects [see clinical studies (14)]. humate-p is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von willebrand factor preparations. animal reproduction studies have not been conducted with humate-p. it is also not known whether humate-p can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. humate-p should be given to a pregnant woman only if clearly needed. it is not known whether humate-p can cause harm to the mother or the fetus when administered during labor and deli

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

csl behring australia pty ltd - factor viii,von willebrand factor -

Israel - English - Ministry of Health

kamada ltd, israel - factor viii; von willebrand factor - powder for solution for injection - factor viii 500 iu/vial; von willebrand factor 1300 iu/vial - von willebrand factor and coagula-tion factor viii in combination - von willebrand factor and coagula-tion factor viii in combination - treatment and prophylaxis of bleeding with haemophilia a (congenital factor viii deficiency).

Israel - English - Ministry of Health

kamada ltd, israel - factor viii; von willebrand factor - powder for solution for injection - factor viii 1000 iu/vial; von willebrand factor 2600 iu/vial - von willebrand factor and coagula-tion factor viii in combination - von willebrand factor and coagula-tion factor viii in combination - treatment and prophylaxis of bleeding with haemophilia a (congenital factor viii deficiency).

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

csl behring australia pty ltd - factor viii, quantity: 250 iu; von willebrand factor, quantity: 500 iu - injection, powder for - excipient ingredients: albumin; calcium chloride dihydrate; plasma proteins; sodium chloride; sodium citrate dihydrate; sucrose; trometamol - ?tbsf? high purity factor viii / von willebrand factor concentrate is indicated for: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. - the prophylaxis and treatment of non-surgical and surgical bleeding associated with fviii deficiency due to haemophilia a.

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

csl behring australia pty ltd - factor viii, quantity: 500 iu; von willebrand factor, quantity: 1200 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.