Israel - engelsk - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

USA - engelsk - 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - sodium ascorbate, quantity: 112.5 mg (equivalent: ascorbic acid, qty 100 mg); ascorbic acid, quantity: 150 mg; zinc gluconate, quantity: 45 mg (equivalent: zinc, qty 6.5 mg) - tablet, chewable - excipient ingredients: hypromellose; magnesium stearate; maize starch; glucose monohydrate; microcrystalline cellulose; sucralose; silicon dioxide; maltodextrin; ascorbic acid; purified water; acacia; soya oil; dunaliella salina; citric acid; sucrose; mixed (low-alpha type) tocopherols concentrate; flavour - maintain/support collagen formation ; maintain/support healthy immune system function ; decrease/reduce/relieve common cold duration ; decrease/reduce/relieve the severity of common cold symptoms ; maintain/support skin health ; maintain/support wound healing

USA - engelsk - NLM (National Library of Medicine)

laboratoire aguettant - zinc gluconate trihydrate (unii: f2f0xu34wq) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/10 mg (equivalent to 70 mg zinc gluconate)/ 1,000 iu

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: hei gruppo pharmaceutica, inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/ 1000 iu

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: tgp pharma inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/ 1,000 iu

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: d.b. manix international, inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/ 1,000 iu per

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: rl pharma enterprises inc. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/ 1,000 iu per

Filippinerne - engelsk - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: all trend savers corp. - ascorbic acid , zinc , cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/ 1,000 iu