Tanzanie - angličtina - Tanzania Medicinces & Medical Devices Authority

shelys pharmaceuticals limited, tanzania - zinc sulfate monohydrate - tablets - 20 mg

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

neo health (otc) pty ltd - calcium carbonate, quantity: 350.059 mg (equivalent: calcium, qty 135.3 mg); calcium hydrogen phosphate, quantity: 224.178 mg (equivalent: calcium, qty 64.7 mg; equivalent: phosphorus, qty 50 mg); potassium sulfate, quantity: 182.868 mg (equivalent: potassium, qty 80 mg); dl-alpha-tocopheryl acetate, quantity: 115 mg (equivalent: dl-alpha-tocopherol, qty 50 mg); ascorbic acid, quantity: 90 mg; heavy magnesium oxide, quantity: 84.6 mg (equivalent: magnesium, qty 50 mg); cyanocobalamin, quantity: 22 microgram; betacarotene, quantity: 1.8 mg; nicotinamide, quantity: 15 mg; ferrous fumarate, quantity: 16.522 mg (equivalent: iron, qty 5 mg); calcium pantothenate, quantity: 14.862 mg (equivalent: pantothenic acid, qty 10 mg); manganese sulfate monohydrate, quantity: 10.875 mg (equivalent: manganese, qty 3.5 mg); zinc oxide, quantity: 9.432 mg (equivalent: zinc, qty 7.5 mg); colecalciferol, quantity: 15 microgram; pyridoxine hydrochloride, quantity: 7.095 mg (equivalent: pyridoxine, qty 5 mg); lycopene, quantity: 600 microgram; riboflavin, quantity: 3.2 mg; thiamine nitrate, quantity: 2.18 mg; cupric sulfate pentahydrate, quantity: 1.984 mg (equivalent: copper, qty 500 microgram); lutein, quantity: 500 microgram; folic acid, quantity: 400 microgram; potassium iodide, quantity: 0.2 mg (equivalent: iodine, qty 150 microgram); sodium selenite pentahydrate, quantity: 0.186 mg (equivalent: selenium, qty 55 microgram); chromic chloride hexahydrate, quantity: 0.183 mg (equivalent: chromium, qty 35 microgram); biotin, quantity: 45 microgram; phytomenadione, quantity: 25 microgram; retinol acetate, quantity: 2.737 mg (equivalent: vitamin a, qty 300 re) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; hypromellose; titanium dioxide; glycerol; purified talc; iron oxide yellow; iron oxide black; iron oxide red; purified water; silicon dioxide; ethylcellulose; mannitol; dl-alpha-tocopherol; hydrogenated castor oil; butylated hydroxyanisole; butylated hydroxytoluene; starch sodium octenyl succinate; acacia; sucrose; maltodextrin; sodium ascorbate; maize oil; liquid glucose - antioxidant/reduce free radicals formed in the body ; helps enhance/promote collagen formation ; maintain/support collagen formation ; maintain/support energy levels ; helps convert (state food) into energy ; maintain/support body metabolism/metabolic rate ; maintain/support vitality ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support general health and wellbeing ; maintain/support hair health ; maintain/support gum health ; maintain/support healthy teeth ; maintain/support nail health/strength/thickness ; maintain/support bone health ; aids/assists healthy bone development/growth/building ; maintain/support (state mineral) absorption in bones ; helps enhance/promote bone mineralisation ; help maintain/support bone mineralisation ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; aid/assist/helps oxygen transport to body tissues ; helps maintain/support haemoglobin formation/synthesis ; maintain/support heart health ; maintain/support immune system health ; helps enhance/improve/promote immune system function ; maintain/support healthy immune system function ; maintain/support muscle health ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral) within normal range ; maintain/support cognitive function/mental function ; maintain/support brain function ; maintain/support brain health ; maintain/support skin health

Spojené státy - angličtina - NLM (National Library of Medicine)

piramal critical care inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [ see warnings and precautions ( 5.6) ]. risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc. parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration ( 2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions ( 5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. in general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Spojené státy - angličtina - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6)] . risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc. parenteral nutrition with zinc should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration (2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions (5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. in general, dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Filipíny - angličtina - FDA (Food And Drug Administration)

progene pharma private limited; importer: health saver pharma inc.; distributor: philgen pharmaceuticals inc. - ferrous sulfate - tablet - 325 mg (equivalent to 105 mg elemental iron)

Filipíny - angličtina - FDA (Food And Drug Administration)

n/a; importer: health saver pharma inc.; distributor: philgen pharmaceuticals inc. - metoprolol tartrate - tablet - 100 mg

Spojené státy - angličtina - NLM (National Library of Medicine)

boehringer ingelheim animal health usa inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 40 [iu] in 1 ml - prozinc is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia. prozinc is contraindicated in dogs sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia.

Spojené státy - angličtina - NLM (National Library of Medicine)

fresenius kabi usa, llc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion [see warnings and precautions (5.4)]. available data with sincalide for injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. however, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. risk summary there are no data regarding the presence of sincalide in human or animal 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 sincalide for injection and any potential adverse effect on the breastfed infant from sincalide for injection or from the underlying condition. the safety and effectiveness in pediatric patients have not been established. clinical studies of sincalide for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - zinc chloride -

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

optimal rx pty ltd - zinc sulfate -