Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, phenylalanine, histidine, arginine, threonine, tryptophan, tyrosine, valine, glycine, methionine, isoleucine, lysine hydrochloride, magnesium chloride, hexahydrate, serine, proline, sodium chloride, sodium lactate - solution for peritoneal dialysis - tryptophan 270 mg/l calcium chloride dihydrate 184 mg/l arginine 1071 mg/l alanine 951 mg/l phenylalanine 570 mg/l histidine 714 mg/l threonine 646 mg/l glycine 510 mg/l methionine 850 mg/l isoleucine 850 mg/l lysine hydrochloride 955 mg/l magnesium chloride hexahydrate 51 mg/l serine 510 mg/l leucine 1020 mg/l proline 595 mg/l sodium chloride 5380 mg/l sodium lactate 4480 mg/l tyrosine 300 mg/l valine 1393 mg/l - blood substitutes and perfusion solutions

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

sanofi pasteur inc. - yellow fever virus strain 17d-204 live antigen (unii: py4eet359t) (yellow fever virus strain 17d-204 live antigen - unii:py4eet359t) - yellow fever virus strain 17d-204 live antigen 4.74 [pfu] in 0.5 ml - yf-vax is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: while the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. greater risk is associated with living in or traveling to areas of south america and africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone. some countries require an individual to have a valid international certificate of vaccination or prophylaxis (icvp) if the individual has been in countries either known or thought to harbor yellow fever virus. the certificate becomes valid 10 days after vaccination with yf-vax. (13) (14)

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

arabian diagnostic and medical company, saudi arabia - haemodialysis solution - concentrate for solution for haemodialysis

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - taliglucerase alfa 200 u (200 u deliverable, plus 6% overage) - powder for injection - 200 u - active: taliglucerase alfa 200 u (200 u deliverable, plus 6% overage) excipient: citric acid mannitol polysorbate 80 sodium citrate dihydrate - elelyso is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of type 1 gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

shs international ltd - powder

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

a-s medication solutions - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 300 mg - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5-tropic human immunodeficiency virus type 1 (hiv-1) infection in patients 2 years of age and older weighing at least 10 kg. limitations of use: selzentry is contraindicated in patients with severe renal impairment or esrd (crcl less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with maraviroc. durin

European Union - English - EMA (European Medicines Agency)

hra pharma rare diseases - mitotane - adrenal cortex neoplasms - antineoplastic agents - symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. the effect of lysodren on non-functional adrenal cortical carcinoma is not established.

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

a-s medication solutions - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5‑tropic human immunodeficiency virus type 1 (hiv‑1) infection in adult and pediatric patients weighing at least 2 kg. limitations of use selzentry is contraindicated in patients with severe renal impairment or esrd (creatinine clearance [crcl] less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with

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

pfizer laboratories div pfizer inc - taliglucerase alfa (unii: 0r4nlx88o4) (taliglucerase alfa - unii:0r4nlx88o4) - taliglucerase alfa 200 u in 5 ml - elelyso is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease. none. risk summary the limited available data on elelyso use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (rhd), there was no evidence of embryo-fetal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women with type 1 gaucher disease have an increased risk of spontaneous abortion if diseas

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

alphapharm pty ltd - ramipril, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; sodium stearylfumarate; pregelatinised maize starch; sodium bicarbonate; croscarmellose sodium; iron oxide yellow; iron oxide red - treatment of hypertension. data are currently not available to support the use of tryzan tabs in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.