Philippines - English - FDA (Food And Drug Administration)

health saver pharma inc - ceftriaxone (as sodium) - powder for injection iv / im - 1g

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

wellstat therapeutics corporation - uridine triacetate (unii: 2wp61f175m) (uridine - unii:whi7hq7h85) - uridine triacetate 951 mg in 1 g - xuriden® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. none risk summary there are no available data on xuriden use in pregnant women to inform a drug-associated risk. when administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (mrhd) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see data] . the background risk of major birth defects and miscarriage for the indicated population 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. data animal data in an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about 2.7 times the maximum recommended human dose (mrhd) of 120

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

wellstat therapeutics corporation - uridine triacetate (unii: 2wp61f175m) (uridine - unii:whi7hq7h85) - uridine triacetate 951 mg in 1 g - vistogard® is indicated for the emergency treatment of adult and pediatric patients: - following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or - who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. limitations of use - vistogard is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. - the safety and efficacy of vistogard initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. none. risk summary limited case reports of uridine triacetate use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. when adminis

Malta - English - Medicines Authority

bialport produtos farmaceuticos s.a. a avenida da siderurgia nacional sao mamede de coronado trofa,porto, portugal - film-coated tablet - cefixime 400 mg - antibacterials for systemic use

Malta - English - Medicines Authority

bialport produtos farmaceuticos s.a. a avenida da siderurgia nacional sao mamede de coronado trofa,porto, portugal - powder for oral suspension - cefixime 100 mg/5ml - antibacterials for systemic use

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 16.1 g - prepopik® is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. prepopik is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium [see warnings and precautions (5.4)] - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in prepopik [see adverse reactions (6.2)] risk summary there are no data with prepopik use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: dreamax incorporated; distributor: dreamax life sciences incorporated - ceftriaxone (as sodium) - powder for injection (im/iv) - 1g

Philippines - English - FDA (Food And Drug Administration)

blue sky trading co. inc - triamcinolone acetonide - cream, topical - 1mg / 1g (0.1% w / w)