Malta - inglise - Medicines Authority

takeda manufacturing austria ag industriestrasse 67, a-1221, vienna, austria - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 1000 iu von willebrand factor, human 750 iu - antihemorrhagics

Ameerika Ühendriigid - inglise - 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

Iisrael - inglise - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 1000 iu / 15 ml; von willebrand factor 2400 iu / 15 ml - coagulation factor viii - coagulation factor viii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia,prophylaxis during operation, von willebrands disease.

Iisrael - inglise - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 250 iu / 5 ml; von willebrand factor 600 iu / 5 ml - coagulation factor viii - coagulation factor viii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia, prophylaxis during operation, von willebrand's disease.

Austraalia - inglise - 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.

Ameerika Ühendriigid - inglise - 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

Euroopa Liit - inglise - 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.

Austraalia - inglise - 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.

Malta - inglise - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 250 iu; von willebrand factor, human 430 iu - antihemorrhagics

Malta - inglise - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 500 iu; von willebrand factor, human 860 iu - antihemorrhagics