Saudo Arabija - anglų - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - human fibrinogen,human thrombin - sealant matrix - 80,500 mg/ml, iu/

Saudo Arabija - anglų - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - human fibrinogen,human thrombin - sealant matrix - 80,500 mg/ml, iu/

Filipinai - anglų - FDA (Food And Drug Administration)

pe pharma enterprises opc; distributor: pe pharma enterprises opc - human fibrinogen , human thrombin - medicated sponge - 5.5 mg/2.0 iu per cm2

Filipinai - anglų - FDA (Food And Drug Administration)

zuellig pharma corp - human thrombin , human fibrinogen - medicated sponge - 2.0iu + 5.5mg per cm2

Europos Sąjunga - anglų - 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.

Kanada - anglų - Health Canada

baxter ag - antithrombin iii (human); water - powder for solution - 1650unit; 30ml - antithrombin iii (human) 1650unit; water 30ml - direct thrombin inhibitors

Malta - anglų - Malta Medicines Authority

baxter healthcare limited - antithrombin iii 50 iu/ml - powder and solvent for solution for infusion or injection

Australija - anglų - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 40 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

csl behring gmbh - prothrombin (unii: 8fb1k07f16) (prothrombin - unii:8fb1k07f16), coagulation factor vii human (unii: 4156xvb4qd) (coagulation factor vii human - unii:4156xvb4qd), coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t), coagulation factor x human (unii: 0p94uqe6sy) (coagulation factor x human - unii:0p94uqe6sy), protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw), protein s human (unii: 90j3f6n5fn) (protein s human - unii:90j3f6n5fn) - prothrombin 590 u in 20 ml - kcentra, (prothrombin complex concentrate (human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin k antagonist (vka, e.g., warfarin) therapy in adult patients with: - acute major bleeding or - need for an urgent surgery/invasive procedure. kcentra is contraindicated in: - patients with known anaphylactic or severe systemic reactions to kcentra or any components in kcentra including heparin, factors ii, vii, ix, x, proteins c and s, antithrombin iii and human albumin. - patients with disseminated intravascular coagulation (dic). - patients with known heparin-induced thrombocytopenia (hit). kcentra contains heparin [see description (11)] . risk summary there are no data with kcentra use in pregnancy to inform on drug-associated risk. animal reproduction studies have not been conducted with kcentra. it is not known whether kcentra can cause fetal harm when administered to a pregnant woman or can affect reproduction

Australija - anglų - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 20 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.