Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , cholecalciferol , zinc - capsule classification: over-the-counter (otc) - 500 mg (equivalent to 562.43 mg sodium ascorbate) 1,000 iu/10 mg (equivalent to 70 mg zinc gluconate) dosage

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals inc. - zinc - chewable tablet - 10 mg (equivalent to 70 mg zinc gluconate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - zinc - film-coated tablet - 10 mg (equivalent to 27.45 mg zinc sulfate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals inc. - zinc - film-coated tablet - 10 mg (equivalent to 70 mg zinc gluconate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc,; importer: n/a; distributor: n/a - zinc - film-coated tablet - 10mg (equivalent to 47.35mg zinc picolinate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc.; importer: n/a; distributor: n/a - ascorbic acid , zinc - capsule - 500 mg (equivalent to 568.18 mg sodium ascorbate) / 10 mg (equivalent to 27.5 mg zinc sulfate monohydrate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , cholecalciferol , zinc - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate) 1,000 iu/10 mg (equivalent to 70 mg zinc gluconate)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 605.20 mg calcium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate) 1,000 iu cholecalciferol (vitamin d3)

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , zinc - syrup - 100 mg/10 mg (equivalent to 27.45 zinc sulfate monohydrate) per 5 ml

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

santarus, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glumetza is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/minute/1.73 m2) [see warnings and precautions ( 5.1)] . - known hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with glumetza 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 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see data]. the estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an hba1c >7 and has been reported to be as high as 20–25% in women with an hba1c >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 2–4% and 15–20%, 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 postmarketing 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 hcl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg. 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 glumetza and any potential adverse effects on the breastfed child from glumetza 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 glumetza may result in ovulation in some anovulatory women. safety and effectiveness of glumetza in pediatric patients have not been established. clinical studies of glumetza did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 dosage and administration ( 2.2) and 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. glumetza is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/minute/1.73 m2 [see dosage and administration ( 2.2), 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. glumetza is not recommended in patients with hepatic impairment [see warnings and precautions ( 5.1)].