爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein - solution for infusion - 100 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein; hbs antibodies - solution for infusion - 50 international unit(s)/millilitre - specific immunoglobulins; hepatitis b immunoglobulin

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - solution for injection - 1.6g/10ml %w/v

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

csl behring gmbh - human plasma protein - solution for injection - 250 international unit(s)/millilitre - specific immunoglobulins; tetanus immunoglobulin

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; zoster immunoglobulin, quantity: 200 iu - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - indications as at 8 august 2002 : zoster immunoglobulin is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. one of the following underlying illnesses or conditions: a. neoplastic disease (leukaemia or lymphoma); b. congenital or acquired immunodeficiency; c. immunosuppressive therapy with steroids or antimetabolites. 2. one of the following types of exposure to chickenpox or shingles patients: a. household contact; b. playmate contact (>1 hour play indoors); c. hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward); d. newborn contact (newborn of mother who had onset of chickenpox <5 days before delivery or within 48 hours after delivery); e. premature infant (>= 28 weeks gestation) whose mother lacks a prior history of chickenpox; f. premature infant (< 28 weeks gestation or <= 1000g) regardless of maternal history. 3. negative or unknown history of chickenpox. 4. if zoster immunoglobulin can be administered within 96 hours after exposure. zoster immunoglobulin, normal immunoglobulin (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. high levels of circulating antibody do not prevent dissemination of infection. zoster immunoglobulin is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

肯尼亚 - 英文 - 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

美国 - 英文 - 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.

马耳他 - 英文 - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - human plasma, protein - solution for injection - human plasma protein 100-180 mg - immune sera and immunoglobulins

马耳他 - 英文 - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - human plasma, protein - solution for infusion or injection - human plasma protein 50 mg/ml - immune sera and immunoglobulins

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - pdr+solv for soln for inf - 0.5 g/30 m micromol