Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 600 iu; factor viii, quantity: 250 iu - injection, powder for - excipient ingredients: calcium chloride dihydrate; sodium chloride; trometamol; sucrose; albumin; sodium citrate dihydrate - von willebrand disease (vwd) - treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated. haemophilia a (congenital fviii deficiency) - prophylaxis and treatment of bleeding in patients with haemophilia a.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 1000 iu; factor viii, quantity: 500 iu - injection, solution - excipient ingredients: water for injections - aleviate is indicated for: ? the treatment of bleeding episodes including surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. ? the treatment and prophylaxis of bleeding associated with factor fviii deficiency due to haemophilia a.

Malta - angleščina - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - factor viii, human - powder and solvent for solution for injection - factor viii, human 25 iu/ml - antihemorrhagics

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

csl behring llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - helixate® fs is a recombinant antihemophilic factor indicated for: helixate fs is not indicated for the treatment of von willebrand disease. helixate 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). pregnancy category c animal reproduction studies have not been conducted with helixate fs. it is also not known whether helixate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. helixate fs should be given to a pregnant woman only if clearly needed. there is no information available on the effect of factor viii replacement therapy on labor and delivery. helixate fs should be used only if clinically needed. it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, caution sho

Združene države Amerike - angleščina - NLM (National Library of Medicine)

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only

Malta - angleščina - 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

Izrael - angleščina - 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).

Izrael - angleščina - 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).

Irska - angleščina - HPRA (Health Products Regulatory Authority)

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