New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) - solution for injection - 100 iu - active: hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) excipient: glycine water for injection - 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 (< 10 iu/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.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - 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 (< 10 iu/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.

Israel - Tiếng Anh - Ministry of Health

kamada ltd, israel - cytomegalovirus antibody; human plasma protein; immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 96 %; human plasma protein 50 mg/ml; cytomegalovirus antibody 100 u/ml - cytomegalovirus immunoglobulin - prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.the concomitant use of adequate virostatic agents should be considered for cmv-prophylaxis.

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - plasma protein containing at least 95% human albumin - solution for infusion - 200 g/l

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - plasma protein containing at least 95% human albumin - solution for infusion - 50 g/l

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - plasma protein fraction (human) - solution for infusion - 2.25/50 per cent

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - human albumin - solution, sterile - 200 mg/ml - human albumin 200 mg/ml

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

csl behring pte. ltd. - human albumin - infusion, solution - 200g/l - human albumin 200g/l

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 2000 [iu] in 4 ml - haegarda is a plasma-derived concentrate of c1 esterase inhibitor (human) (c1-inh) indicated for routine prophylaxis to prevent hereditary angioedema (hae) attacks in patients 6 years of age and older. haegarda is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1-inh preparations or its excipients [see description (11)]. risk summary there are no prospective clinical data from haegarda use in pregnant women. c1-inh is a normal component of human plasma. animal developmental or reproduction toxicity studies have not been conducted with haegarda. in the u.s. general population, the estimated background risk of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. data in a retrospective case collection study, 22 pregnant women with type i hae and ranging in age from 20 to 38 years received c1-inh doses of 500 or 1000 iu per i.v. administration for the treatmen

Hoa Kỳ - Tiếng Anh - 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.