Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults 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; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - 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 a hypersensitivity reaction 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 for inj

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

fosun pharma usa inc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults 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; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - 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 a hypersensitivity reaction to 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 for

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

ilia, inc. - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

ilia, inc. - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

ilia, inc. - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bracco diagnostics inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 5 ug in 5 ml - kinevac 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. kinevac 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

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

carson life, inc - pyrithione zinc (unii: r953o2rhz5) (pyrithione zinc - unii:r953o2rhz5) - pyrithione zinc 2.41 g in 237 ml - purpose: anti dandruff stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed directions for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, and repeat if desired for best results use least twice a week or as directed by a doctor use every time you shampoo wet hair, massage onto scalp, rinse, and repeat if desired for best results use least twice a week or as directed by a doctor.

Amerikas Savienotās Valstis - angļu - 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.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

american regent, inc. - zinc sulfate heptahydrate (unii: n57ji2k7wp) (zinc cation - unii:13s1s8sf37), cupric sulfate (unii: lrx7aj16dt) (cupric cation - unii:8cbv67279l), manganese sulfate (unii: w00lys4t26) (manganese cation (2+) - unii:h6ep7w5457), chromic chloride (unii: kb1pcr9dmw) (chromic cation - unii:x1n4508kf1) - zinc cation 6.6 mg in 1 ml - multitrace ® - 4 neonatal is indicated for use as a supplement to intravenous solutions given for tpn. administration of multitrace ® - 4 neonatal in tpn solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms. multitrace ® - 4 neonatal should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Eiropas Savienība - angļu - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipid modifying agents - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.