Австралія - англійська - 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.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - factor ix, human - powder and solvent for solution for injection - 500 international unit(s) - blood coagulation factors; coagulation factor ix

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - factor ix, human - powder and solvent for solution for injection - 1000 international unit(s) - blood coagulation factors; coagulation factor ix

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 500/500 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 1000/1000 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

Бельгія - англійська - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - protein s 12 iu/ml - 32 iu/ml; human coagulation factor x 18 iu/ml - 30 iu/ml; human coagulation factor ix 25 iu/ml; human coagulation factor ii 14 iu/ml - 38 iu/ml; protein c 7 iu/ml - 31 iu/ml; human coagulation factor vii 9 iu/ml - 24 iu/ml - powder and solvent for solution for infusion - 500 iu - human coagulation factor ii 14.5 iu/ml; human coagulation factor ix 25 iu/ml; human coagulation factor vii 16.5 iu/ml; human coagulation factor x 24 iu/ml; protein c 19 iu/ml; protein s 19.5 iu/ml - coagulation factor ix, ii, vii and x in combination

Бельгія - англійська - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - human coagulation factor ii 14 iu/ml - 38 iu/ml; human coagulation factor ix 25 iu/ml; protein c 13 iu/ml - 31 iu/ml; human coagulation factor vii 9 iu/ml - 24 iu/ml; human coagulation factor x 18 iu/ml - 30 iu/ml; protein s 12 iu/ml - 32 iu/ml - powder and solvent for solution for infusion - 1000 ui - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix 25 iu/ml; human coagulation factor x; protein c; protein s - coagulation factor ix, ii, vii and x in combination

Канада - англійська - Health Canada

octapharma pharmazeutika produktionsges m b h - coagulation factor ii (human); coagulation factor vii (human); coagulation factor ix (human); coagulation factor x (human); protein c; protein s - kit - 760unit; 480unit; 500unit; 600unit; 620unit; 640unit - coagulation factor ii (human) 760unit; coagulation factor vii (human) 480unit; coagulation factor ix (human) 500unit; coagulation factor x (human) 600unit; protein c 620unit; protein s 640unit - hemostatics

США - англійська - 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

Канада - англійська - Health Canada

octapharma pharmazeutika produktionsges m b h - coagulation factor ii (human); coagulation factor vii (human); coagulation factor ix (human); coagulation factor x (human); protein c; protein s - kit - 1520unit; 960unit; 1000unit; 1200unit; 1240unit; 1280unit - coagulation factor ii (human) 1520unit; coagulation factor vii (human) 960unit; coagulation factor ix (human) 1000unit; coagulation factor x (human) 1200unit; protein c 1240unit; protein s 1280unit - hemostatics