Malta - engleski - Malta 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

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

csl behring australia pty ltd - factor ix, quantity: 500 iu; factor x, quantity: 500 iu; factor ii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - prothrombinex-vf is indicated in - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex 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. - treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available (see precautions).

Kanada - engleski - Health Canada

instituto grifols s.a. - fibrinogen (human); thrombin (human) - solution - 80mg; 500unit - fibrinogen (human) 80mg; thrombin (human) 500unit - hemostatics

Kanada - engleski - Health Canada

instituto grifols s.a. - thrombin (human); fibrinogen (human) - solution - 1500unit; 240mg - thrombin (human) 1500unit; fibrinogen (human) 240mg - hemostatics

Kanada - engleski - Health Canada

instituto grifols s.a. - fibrinogen (human); thrombin (human) - solution - 400mg; 2500unit - fibrinogen (human) 400mg; thrombin (human) 2500unit - hemostatics

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

takeda uk ltd - human fibrinogen; thrombin - implant - 5.5mg/1square cm ; 2unit/1square cm

Irska - engleski - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

Kenija - engleski - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

grifols usa, llc - antithrombin iii human (unii: t0lto7l82x) (antithrombin iii human - unii:t0lto7l82x) - antithrombin iii human 50 [iu] in 1 ml - thrombate iii is a human antithrombin (at) indicated in patients with hereditary antithrombin deficiency for: - treatment and prevention of thromboembolism - prevention of peri-operative and peri-partum thromboembolism none. risk summary there are no data with thrombate iii use in pregnant women to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . it is not known whether thrombate iii can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thrombate iii should be given to a pregnant woman only if clearly needed. 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. reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to thrombate iii. clinical considerations labor or delivery suspend heparin (or low molecular weight heparin) administration and continue thrombate iii administration during labor and delivery. risk summary there is no information regarding the presence of thrombate iii in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for thrombate iii and any potential adverse effects on the breastfed infant from thrombate iii or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. the safety and effectiveness in the geriatric population have not been established.

Irska - engleski - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human fibrinogen - powder and solvent for solution for injection/infusion - 1 gram(s) - fibrinogen, human