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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

Israeli - Kiingereza - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 200 - 320 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Israeli - Kiingereza - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 1250 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.evicel is also indicated as suture support for haemostasis in vascular surgery.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human thrombin - hemostasis - local hemostatics - supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):- for improvement of haemostasis.

Australia - Kiingereza - 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

csl behring gmbh - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 1300 mg in 50 ml - riastap® , fibrinogen concentrate (human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. limitation of use riastap is not indicated for dysfibrinogenemia. riastap is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products. risk summary there are no studies of riastap use in pregnant women. animal reproduction studies have not been conducted with riastap. it is not known whether riastap can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of riastap in human milk, its effects on the breastfed infant, or its effects on mi

Malta - Kiingereza - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 182 mg aprotinin 6000 kiu/ml human thrombin 1000 iu calcium chloride dihydrate 80 µmol - antihemorrhagics

Malta - Kiingereza - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 455 mg aprotinin 1500 kiu/ml human thrombin 2500 iu calcium chloride dihydrate 200 mmol - antihemorrhagics

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

bpl bioproducts laboratory gmbh - human coagulation factor x - factor x deficiency - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor x deficiency. coagadex is indicated in all age groups.