Singapore - English - HSA (Health Sciences Authority)

pharmeng technology pte. ltd. - human thrombin; human fibrinogen - sponge - 2.0 iu per sq cm - human thrombin 2.0 iu per sq cm; human fibrinogen 5.5 mg per sq cm

European Union - English - myHealthbox

takeda austria gmbh - human fibrinogen / human thrombin - sealant matrix - 5.5 mg human fibrinogen and 2.0 iu human thrombin per cm² - hemostasis, surgical - local haemostatics - indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient

European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

corza medical gmbh - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).

European Union - English - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.raplixa must be used in combination with an approved gelatin sponge.raplixa is indicated in adults over 18 years of age.

Canada - English - Health Canada

baxter corporation - sealer protein (human); aprotinin (synthetic); thrombin (human); calcium chloride - solution - 125mg; 3000kiu; 4unit; 40mcmol - sealer protein (human) 125mg; aprotinin (synthetic) 3000kiu; thrombin (human) 4unit; calcium chloride 40mcmol - hemostatics

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, aprotinin, fibrinogen, human, thrombin - solution for sealant - calcium chloride 40 µmole/ml aprotinin 3000 kiu/ml fibrinogen, human 91 mg/ml thrombin, human 500 iu/mg - antihemorrhagics

Malta - English - 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 - English - 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

Israel - English - Ministry of Health

baxter healthcare distribution ltd., israel - aprotinin acetate; calcium chloride dihydrate; human fibrinogen; human thrombin - solutions for sealant - calcium chloride dihydrate 40 mcmol/ml; human thrombin 500 iu / 1 ml; aprotinin acetate 3000 kiu / 1 ml; human fibrinogen 91 mg / 1 ml - combinations - supportive treatment in adults and children from 1 month of age where standard surgical techniques appear insufficient: * for improvement of hemostasis.* as a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses.* for tissue sealing, to improve adhesion of the separated tissue (e.g. tissue flaps, grafts, split skin grafts [mesh grafts]).efficacy in fully heparinized patients has been proven.