United States - English - NLM (National Library of Medicine)

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). 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. data animal data optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres 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 optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

United States - English - NLM (National Library of Medicine)

cangene biopharma - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 1.25 [iu] in 1 ml - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. pregnancy category c. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 adverse reactions and 14 clinical studies]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing moth

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

ksj pharmatech - human thrombin, quantity: 2 iu/cm2; fibrinogen, quantity: 5.5 mg/cm2 - sponge, medicated - excipient ingredients: sodium chloride; riboflavin; collagen; sodium citrate dihydrate; arginine hydrochloride; albumin - ? tachosil? is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

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

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

United States - English - NLM (National Library of Medicine)

adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 312 [iu] in 1 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

United States - English - NLM (National Library of Medicine)

octapharma usa inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - octagam 10% is indicated for the treatment of chronic immune thrombocytopenic purpura to rapidly raise platelet counts to control or prevent bleeding in adults. octagam 10% is indicated for the treatment of dermatomyositis in adults. - octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - octagam 10% contains trace amounts of iga (average 106 µg/ml in a 10% solution). it is contraindicated in iga-deficient patients with antibodies against iga and history of hypersensitivity . risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with octagam 10%. it is not known whether octagam 10% can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. octagam 10% should be given t

European Union - English - EMA (European Medicines Agency)

xbiotech germany gmbh - human igg1 monoclonal antibody specific for human interleukin-1 alpha - colorectal neoplasms - antineoplastic agents - treatment of metastatic colorectal cancer

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn bhd - human albumin -

Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 900 - 1300 mg / 1 vials - fibrinogen, human - fibrinogen, human - haemocomplettan p 1g/2g, fibrinogen concentrate (human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.haemocomplettan p 1g/2g is not indicated for dysfibrinogenemia.

Israel - English - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for infusion - human hepatitis b immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - prophylaxis against hepatitis b in adults and children over 2 years of age who have not been vaccinated against hepatitis b (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis b by accidental contact with hepatitis b virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. when the administration of an intramuscular hepatitis b immunoglobulin is not possible. the immunoglobulin should be administered in association with hepatitis b vaccine. prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis b virus. immunoprophylaxis of hepatitis b in the newborn of a hepatitis b virus carrier mother.