United States - English - 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

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

robin pharmaceuticals limited - titanium dioxide; zinc oxide; benzalkonium chloride; cetrimide - topical cream, ointment, paste, gel, lotion - titanium dioxide mineral-titanium active 140.0 mg/g; zinc oxide mineral-zinc active 80.0 mg/g; benzalkonium chloride ammonium-quaternary active 0.8 mg/g; cetrimide ammonium-quaternary active 3.0 mg/g - dermatological preps. - cattle | dog | goat | horse | sheep | beef | billy | bitch | bos indicus | bos taurus | bovine | buck | buffalo | bull | bullock - antibiotic - anti-infective | cracking & chapping of teat | protection against sunburn | wound dressing | abrasions | abscesses | airsacculitis | antiseptic | avian mycoplasmas | blackhead | body odours | bowed tendons | broad spectrum | burns | coccidiosis | coliform complex | conjunctivitis | cowpox | cracks | crusts | dandruff | dermatological disorders | dermatosis | dry skin | dysentery | eczema | endometritis | enteric diseases | enzootic pneumonia | feed efficiency | fungal infections | girth galls | infections | inflammed pads | itching | keratolytic | lacerations | mastitis | mycoplasmas | odours | open wounds | otitis | poultice dressing | prevention of effects uva & uv | pruritis | queensland itch | respiratory disease | saddle rash | salmonellosis | scabs | scaly skin | sheath rot | skin cancer | skin irritations | solar keratoses | sores | sunspots & skin aging | swine dysentery | teat cracking | teat infections | topical infections | udder sores | udder teat cracking/chapping | weight gain | wir

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

Australia - English - Department of Health (Therapeutic Goods Administration)

care pharmaceuticals pty ltd - zinc oxide -

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

valeant pharmaceuticals - titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - titanium dioxide 4.9 g in 100 g - titanium dioxide 4.9%                             sunscreen zinc oxide 4.7%                                       sunscreen - helps prevent sunburn - if used as directed with other sun protection messures (see ​directions ​) decreases the risk of skin cancer and early skin aging caused by sun.

United States - English - 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.

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

ani pharmaceuticals, inc. - methazolamide (unii: w733b0s9sd) (methazolamide - unii:w733b0s9sd) - methazolamide 25 mg - methazolamide tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery. methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. in patients with cirrhosis, use may precipitate the development of hepatic encephalopathy. long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

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

aveo pharmaceuticals, inc. - tivozanib hydrochloride (unii: 8a9h4vk35z) (tivozanib - unii:172030934t) - fotivda is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (rcc) following two or more prior systemic therapies. none. risk summary based on findings in animal studies and its mechanism of action, fotivda can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on fotivda use in pregnant woman to inform the drug-associated risk. in embryo-fetal developmental studies, oral administration of tivozanib to pregnant animals during the period of organogenesis caused maternal toxicity, fetal malformations and embryo-fetal death at doses below the maximum recommended clinical dose on a mg/m2 basis (see data) . advise pregnant woman of the potential risk to a fetus. 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

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - inclisiran, quantity: 284 mg - injection, solution - excipient ingredients: sodium hydroxide; phosphoric acid; water for injections - leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (ldl-c) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? 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 or,,? alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.