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)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin 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 material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. 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.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml; cytomegalovirus immunoglobulin, quantity: 1500000 u - injection, intravenous infusion - excipient ingredients: water for injections; human immunoglobulin a; maltose - cmv immunoglobulin-vf is indicated for the prevention of cmv infection following bone marrow and renal transplants. specifically, the product is indicated when the recipient is seronegative for cmv and receives a graft from a cmv positive donor. cmv immunoglobulin-vf may also be a helpful adjunct to therapy in patients with established cmv infection, e.g. cmv pneumonitis.

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

ethicon inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 85 mg in 1 ml - evicel® fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. do not use evicel®: - directly into the circulatory system. intravascular application of evicel® may result in life-threatening thromboembolic events [see warnings and precautions, (5.1) and adverse reactions, (6.2)]. - in individuals known to have anaphylactic or severe systemic reaction to human blood products [see adverse reactions (6.2)]. - for brisk arterial bleeding. - for spraying in endoscopic or laparoscopic procedures in those instances where the minimum recommended distance from the applicator tip to the target site cannot be ensured. [see dosage and administration (2.3)]. risk summary there are no data with evicel® use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with evicel® . it is not known whether

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

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) - 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 infec- tion 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 hbeag 12 . - sexual exposure to hbsag-positive persons: sexual partners of hbsag-positive persons. - household exposure to persons with acute hbv infection: household exposure to persons with acute hbv infection: infants less than 12 months old whose mother or primary caregiver is positive for hbsag. o

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

grifols usa, llc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - vistaseal is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. vistaseal is effective in heparinized patients. - do not inject directly into the circulatory system. [see warnings and precautions (5.1)] - do not use for the treatment of severe or brisk arterial bleeding. in these situations, blood flow will wash away vistaseal and prevent hemostasis. - do not use vistaseal in patients known to have anaphylactic or severe systemic hypersensitivity reactions to the administration of human blood products. [see warnings and precautions (5.2)] - do not use vistaseal for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. [see dosage and administration (2.3)] risk summary there are no available data with vistaseal use in pregnant women. animal reproduction studies have not been perfo

Ireland - English - HPRA (Health Products Regulatory Authority)

csl behring gmbh - human albumin solution - solution for infusion - 20, 200 gram(s)/litre - albumin

Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 1800 - 2600 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.