Estados Unidos - inglês - NLM (National Library of Medicine)

a-s medication solutions - sitagliptin phosphate (unii: ts63ew8x6f) (sitagliptin - unii:qfp0p1dv7z) - januvia® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use januvia should not be used in patients with type 1 diabetes. januvia has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using januvia. [see warnings and precautions (5.1).] history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [see warnings and precautions (5.5) ; adverse reactions (6.2).] risk summary the limited available data with januvia in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. no adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on auc [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hemoglobin a1c >7% and has been reported to be as high as 20-25% in women with a hemoglobin a1c >10%. 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 in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data in embryo-fetal development studies, sitagliptin administered to pregnant rats and rabbits during organogenesis (gestation day 6 to 20) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (30-times the 100 mg clinical dose) and 125 mg/kg (20-times the 100 mg clinical dose), respectively, based on auc. higher doses in rats associated with maternal toxicity increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100-times the clinical dose, based on auc. placental transfer of sitagliptin was observed in pregnant rats and rabbits. sitagliptin administered to female rats from gestation day 6 to lactation day 21 caused no functional or behavioral toxicity in offspring of rats at doses up to 1000 mg/kg. risk summary there is no information regarding the presence of januvia in human milk, the effects on the breastfed infant, or the effects on milk production. sitagliptin is present in rat milk and therefore possibly present in human milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for januvia and any potential adverse effects on the breastfed infant from januvia or from the underlying maternal condition. data sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. the safety and effectiveness of januvia have not been established in pediatric patients. three 20-week double-blind, placebo-controlled studies each with 34-week extensions were conducted to evaluate the efficacy and safety of sitagliptin in 410 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes, with or without insulin therapy (hba1c 6.5-10% for patients not on insulin, hba1c 7-10% for patients on insulin). at study entry, patients in study 1 were not treated with oral antihyperglycemic agents; patients in studies 2 and 3 were on maximally tolerated metformin therapy. the primary efficacy endpoint was the change from baseline in hba1c after 20 weeks of therapy. the pre-specified primary efficacy analyses included data from study 1 and pooled data from studies 2 and 3, regardless of glycemic rescue or treatment discontinuation. in both efficacy analyses, the effect of treatment with sitagliptin was not significantly different from placebo. in study 1, the mean baseline hba1c was 7.5%, and 12% of patients were on insulin therapy. at week 20, the change from baseline in hba1c in patients treated with januvia (n=95) was 0.06% compared to 0.23% in patients treated with placebo (n=95), a difference of -0.17% (95% ci: -0.62, 0.28). in studies 2 and 3, the mean baseline hba1c was 8.0%, 15% of patients were on insulin and 72% were on metformin hcl doses of greater than 1,500 mg daily. at week 20, the change from baseline in hba1c in patients treated with sitagliptin (n=107) was -0.23% compared to 0.09% in patients treated with placebo (n=113), a difference of -0.33% (95% ci: -0.70, 0.05). of the total number of subjects (n=3884) in pre-approval clinical safety and efficacy studies of januvia, 725 patients were 65 years and over, while 61 patients were 75 years and over. no overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. while this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. because sitagliptin is substantially excreted by the kidney, and because aging can be associated with reduced renal function, renal function should be assessed more frequently in elderly patients [see dosage and administration (2.2), warnings and precautions (5.3)] . sitagliptin is excreted by the kidney, and sitagliptin exposure is increased in patients with renal impairment. lower dosages are recommended in patients with egfr less than 45 ml/min/1.73 m2 (moderate and severe renal impairment, as well as in esrd patients requiring dialysis). [see dosage and administration (2.2); clinical pharmacology (12.3).]

Estados Unidos - inglês - NLM (National Library of Medicine)

cardinal health - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 8 mg - the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. ondansetron tablets and ondansetron orally disintegrating tablets are contraindicated for patients known to have hypersensitivity to the drug. animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - simvastatin; ezetimibe - oral tablet - 20mg ; 10mg

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - simvastatin; ezetimibe - oral tablet - 40mg ; 10mg

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - simvastatin; ezetimibe - oral tablet - 80mg ; 10mg

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

felton grimwade & bosisto's pty ltd - cupric sulfate pentahydrate, quantity: 98.24 microgram/ml (equivalent: copper, qty 25 microgram/ml); potassium iodide, quantity: 6.54 microgram/ml (equivalent: iodine, qty 5 microgram/ml); manganese sulfate monohydrate, quantity: 144 microgram/ml (equivalent: manganese, qty 46.7 microgram/ml); nicotinamide, quantity: 667 microgram/ml; thiamine hydrochloride, quantity: 667 microgram/ml; riboflavin sodium phosphate, quantity: 456 microgram/ml (equivalent: riboflavin, qty 333 microgram/ml); zinc gluconate, quantity: 2.48 mg/ml (equivalent: zinc, qty 333 microgram/ml); dexpanthenol, quantity: 667 microgram/ml; pyridoxine hydrochloride, quantity: 667 microgram/ml (equivalent: pyridoxine, qty 549 microgram/ml); iron (ii) glycinate, quantity: 2.92 mg/ml (equivalent: iron, qty 800 microgram/ml) - oral liquid - excipient ingredients: vanillin; silicon dioxide; citric acid monohydrate; sodium cyclamate; ascorbic acid; potassium sorbate; maltodextrin; caramel; glycerol; saccharin sodium; sorbitol solution (70 per cent) (non-crystallising); purified water; propyl gallate; xanthan gum; flavour - enhance/promote energy levels ; maintain/support energy levels ; helps enhance/promote general health and wellbeing ; maintain/support general health and wellbeing ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support (state vitamin/mineral) within normal range

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

felton grimwade & bosisto's pty ltd - thiamine hydrochloride, quantity: 667 microgram/ml; dexpanthenol, quantity: 667 microgram/ml; pyridoxine hydrochloride, quantity: 667 microgram/ml (equivalent: pyridoxine, qty 549 microgram/ml); cupric sulfate pentahydrate, quantity: 98.24 microgram/ml (equivalent: copper, qty 25 microgram/ml); sodium selenite pentahydrate, quantity: 5.55 microgram/ml (equivalent: selenium, qty 1.67 microgram/ml); eleutherococcus senticosus, quantity: 1.67 mg/ml (equivalent: eleutherococcus senticosus, qty 16.7 mg/ml); nicotinamide, quantity: 667 microgram/ml; zinc gluconate, quantity: 2.48 mg/ml (equivalent: zinc, qty 333 microgram/ml); riboflavin sodium phosphate, quantity: 456 microgram/ml (equivalent: riboflavin, qty 333 microgram/ml); manganese sulfate monohydrate, quantity: 144 microgram/ml (equivalent: manganese, qty 46.7 microgram/ml); potassium iodide, quantity: 6.54 microgram/ml (equivalent: iodine, qty 5 microgram/ml); ginkgo biloba, quantity: 334 microgram/ml (equivalent: ginkgo flavonglycosides, qty 89.178 microgram/ml; equivalent: ginkgolides and bilobalide, qty 22.378 microgram/ml; equivalent: ginkgo biloba, qty 16700 microgram/ml) - oral liquid - excipient ingredients: sodium cyclamate; citric acid monohydrate; glycerol; caramel; potassium sorbate; saccharin sodium; vanillin; sorbitol solution (70 per cent) (non-crystallising); purified water; xanthan gum; propyl gallate; flavour - enhance/promote energy levels ; maintain/support energy levels ; helps enhance/promote general health and wellbeing ; maintain/support general health and wellbeing ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; maintain/support (state vitamin/mineral) within normal range ; traditionally used in western herbal medicine to maintain/support mental concentration/focus/clarity ; enhance/improve/promote/increase mental alertness/wakefulness ; maintain/support memory/mental recall

Nova Zelândia - inglês - Ministry for Primary Industries

corteva agriscience new zealand limited - haloxyfop-p - haloxyfop-p 520 g/litre - herbicide

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - the gallant dr model cddra500q dual chamber implantable cardioverter defibrillator (icd) monitors and regulates a patient?s heart rate and provides treatment of ventricular arrhythmias. incorporates the at/af detection algorithm indicated in patients with (or those at significant risk) of developing atrial tachyarrhythmias. this device is mr conditional. to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the gallant model cdvra500q single chamber implantable cardioverter defibrillator (icd) monitors and regulates a patient?s heart rate and provides treatment of ventricular arrhythmias. this device is mr conditional. to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation.