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

stallergenes australia pty ltd - vespula spp venom, quantity: 550 microgram - injection, powder for - excipient ingredients: mannitol - indicated use of allergenic extracts is for the diagnosis and treatment (hypo-sensitization therapy) of patients who experience allergic symptoms.

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

cst pharma ltd - rifaximin - oral tablet - 550mg

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

pilsco ltd - rifaximin - oral tablet - 550mg

Giordania - inglese - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الرام للصناعات الدوائية - ram pharmaceutical industries co. ltd. - naproxen sodium 550 mg - 550 mg

Giordania - inglese - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الرام للصناعات الدوائية - ram pharmaceutical industries co. ltd. - naproxen 550 mg - 550 mg

Giordania - inglese - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الحياة للصناعات الدوائية - hayat pharmaceutical industries co.plc - naproxen sodium 550 mg - 550 mg

Stati Uniti - inglese - NLM (National Library of Medicine)

avpak - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see warnings and precautions (5.1)] . - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when metformin was administered to pregnant sprague dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2,550 mg clinical dose, based on body surface area [see data]. the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes mellitus with an hba 1c > 7 and has been reported to be as high as 20% to 25% in women with a hba 1c > 10. the estimated background risk of miscarriage for the indicated population is 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 poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. however, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. animal data metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. this represents an exposure of about 2 and 5 times a 2,550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. determination of fetal concentrations demonstrated a partial placental barrier to metformin. risk summary limited published studies report that metformin is present in human milk [see data]. however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for metformin hydrochloride extended-release tablets and any potential adverse effects on the breastfed child from metformin hydrochloride extended-release tablets or from the underlying maternal condition. data published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. however, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin hydrochloride extended-release tablets may result in ovulation in some anovulatory women. metformin hydrochloride extended-release tablets safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established. controlled clinical studies of metformin hydrochloride extended-release tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. assess renal function more frequently in elderly patients [see warnings and precautions (5.1)] . metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. metformin hydrochloride extended-release tablets are contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m 2 [see dosage and administration (2.3), contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)] . use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. metformin hydrochloride extended-release tablets are not recommended in patients with hepatic impairment. [see warnings and precautions (5.1)] .

Canada - inglese - Health Canada

univet pharmaceuticals ltd. - methylprednisolone acetate - suspension - 40mg - methylprednisolone acetate 40mg - dogs; horses

Canada - inglese - Health Canada

abbott laboratories, limited - potassium chloride - powder for solution - 1.5g - potassium chloride 1.5g - replacement preparations

Canada - inglese - Health Canada

produits cadillac (1984) ltee - triclosan - gel - .3% - triclosan .3% - miscellaneous local anti-infectives