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

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.

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)

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

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

actavis pharma, inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. - known hypersensitivity to sodium ferric gluconate or any of its components. pregnancy category b there are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). the doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly need

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

actavis pharma, inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. - known hypersensitivity to sodium ferric gluconate or any of its components. pregnancy category b there are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). the doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly ne

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