Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - rivastigmine, quantity: 27 mg - drug delivery system, transdermal - excipient ingredients: acrylates copolymer; dl-alpha-tocopherol; dimeticone 12500; ethyl acetate; methylated trimethylated silica; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - exelon / prometax is indicated for the treatment of patients with mild, moderate and severe dementia of the alzheimer's type.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 15 mg - lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: lansoprazole/amoxicillin/clarithromycin lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole/amoxicillin lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who

Združene države Amerike - angleščina - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: • major depressive disorder [see clinical studies (14.1)] • generalized anxiety disorder [see clinical studies (14.2)] • diabetic peripheral neuropathy [see clinical studies (14.3)] • chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increa

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - choline fenofibrate (unii: 4bmh7izt98) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 45 mg - fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (tg) in patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see warnings and precautions (5.1)] . laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy. every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. if the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of vldl. fenofibric acid is contraindicated in: - patients with severe renal impairment, including those receiving dialysis[see clinical pharmacology (12.3)]. - patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see warnings and precautions (5.3)]. - patients with preexisting gallbladder disease [see warnings and precautions (5.5)]. - nursing mothers [see use in specific populations (8.2)]. - patients with hypersensitivity to fenofibric acid or fenofibrate[see warnings and precautions (5.9)]. risk summary limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2 ). adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see data). fenofibric acid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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: in pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [mrhd] of 300 mg fenofibrate daily, equivalent to 135 mg fenofibric acid daily, based on body surface area comparisons). increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the mrhd) that significantly suppressed maternal body weight gain. in pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the mrhd, based on body surface area comparisons). aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the mrhd) that suppressed maternal body weight gain. in pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the mrhd, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the mrhd) in the presence of maternal toxicity (decreased weight gain). decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the mrhd), which was associated with decreased maternal body weight gain/maternal neglect. risk summary there is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk. because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibric acid and for 5 days after the final dose [see contraindications (4)] . the safety and effectiveness of fenofibric acid in pediatric patients have not been established. fenofibric acid is substantially excreted by the kidney as fenofibric acid and fenofibric acid glucuronide, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. fenofibric acid exposure is not influenced by age. since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see dosage and administration (2.5 ) and clinical pharmacology  (12.3)]. elderly patients with normal renal function should require no dose modifications. consider monitoring renal function in elderly patients taking fenofibric acid. the use of fenofibric acid should be avoided in patients who have severe renal impairment [see contraindications (4)] . dose reduction is required in patients with mild to moderate renal impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. monitoring renal function in patients with renal impairment is recommended. the use of fenofibric acid has not been evaluated in subjects with hepatic impairment [see contraindications (4) and clinical pharmacology  (12.3)].

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 75 mg - diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications [see warnings and precautions (5.3)]. diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: risk summary diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see contraindications (4)] . if a woman becomes pregnant while taking diclofenac sodium and misoprostol delayed-release tablets, discontinue the drug and advise the woman of the potential risks to her and to a fetus. there are no adequate and well-controlled studies of diclofenac sodium and misoprostol delayed-release tablets in pregnant women; however, there is information available

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 60 mg - duloxetine delayed-release capsules are indicated for the treatment of: monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and precautions (5.4)] . teratogenic effects pregnancy category c risk summary — there are no adequate and well-controlled studies of duloxetine delayed-release capsules administr

Združene države Amerike - angleščina - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - adults nexium delayed-release capsules and nexium for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of nexium may be considered. pediatric patients 12 years to 17 years of age nexium delayed-release capsules and nexium for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. pediatric patients 1 year to 11 years of age nexium for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of ee in pediatric patients 1 year to 11 years of age. pediatric patients 1 month to less than 1 year of age nexium for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of ee due to acid-mediated gerd in pediat

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence.   triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults.   dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults.   among patients who fail therapy, omeprazole delayed-release capsules are with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, su

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 40 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months.   pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. risk summary available data from published observational st

Združene države Amerike - angleščina - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - mycophenolic acid (unii: hu9dx48n0t) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid 180 mg - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing