Irsko - angličtina - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 1000 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma coagulation factor ii; human plasma coagulation factor vii; human plasma coagulation factor ix; human plasma coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 500 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 10 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - factor x, quantity: 360 iu; plasma proteins, quantity: 260 mg; protein c, quantity: 140 iu; protein s, quantity: 140 iu; factor ii, quantity: 220 iu; factor vii, quantity: 180 iu; factor ix, quantity: 500 iu - injection, solution - excipient ingredients: water for injections - treatment of bleeding and perioperative prophylaxis of bleeding 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. as a second line therapy for the control of bleeding episodes and surgical prophylaxis in patients with congenital factor vii deficiency, for whom recombinant human fviia has failed, is contraindicated or has been associated with unacceptable adverse effects.

Austrálie - angličtina - 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.

Austrálie - angličtina - 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 10 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.

Spojené státy - angličtina - 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

Spojené státy - angličtina - NLM (National Library of Medicine)

octapharma usa inc - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk), von willebrand factor human (unii: ze22ne22f1) (von willebrand factor human - unii:ze22ne22f1) - antihemophilic factor human 100 [iu] in 1 ml - wilate is indicated in children and adults with von willebrand disease for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding wilate is indicated in adolescents and adults with hemophilia a for: - routine prophylaxis to reduce the frequency of bleeding episodes - on-demand treatment and control of bleeding episodes wilate is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation [see description (11) ] , or components of the container. risk summary there are no data with wilate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with wilate. wilate was given to four subjects (3 type 3 and 1 type 2b) during labor and delivery in one clinical study. two subjects underwent vaginal delivery (type 3) and two subjects had a cesarean section (type 3/type 2b). in this study all pro

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

csl limited - factor ii; factor ix; factor x -