Australia - angielski - 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).

Unia Europejska - angielski - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - antithrombin iii deficiency - antithrombotic agents - atryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. atryn is normally given in association with heparin or low molecular weight heparin.

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

revo biologics, inc. - antithrombin alfa (unii: awv6i5l6h2) (antithrombin alfa - unii:awv6i5l6h2) - antithrombin alfa 525 [iu] in 1 ml - atryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1 . it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. atryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. risk summary atryn is indicated for the treatment of pregnant women during the peri-partum period. pregnant patients who need a surgical procedure other than cesarean section are to be treated according to the dosing formula for pregnant patients. in rats, a dose of 210 mg/kg/day atryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). this slight statistical difference does no

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

meijer distributing inc. - titanium dioxide  3.2%, zinc oxide 4.0% - sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Izrael - angielski - Ministry of Health

mbi pharma ltd., israel - azithromycin as dihydrate - powder for solution for infusion - azithromycin as dihydrate 500 mg - azithromycin - treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: community-acquired pneumonia and pelvic inflammatory disease.

Japonia - angielski - すりの適正使用協議会 RAD-AR Council, Japan

mochida pharmaceutical co., ltd. - thrombin - white fine granules

Japonia - angielski - すりの適正使用協議会 RAD-AR Council, Japan

mochida pharmaceutical co., ltd. - thrombin - white fine granules

Australia - angielski - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 125 mg; lumacaftor, quantity: 100 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350; cochineal; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Australia - angielski - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - lumacaftor, quantity: 150 mg; ivacaftor, quantity: 188 mg - granules - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium lauryl sulfate; hypromellose acetate succinate - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.