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

novel laboratories, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - sodium phosphate, monobasic, monohydrate 1.105 g - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. laxatives and purgatives (including monobasic sodium phosphate and dibasic sodium phosphate tablets) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.

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

lupin pharmaceuticals,inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in the following conditions: -   history of acute phosphate nephropathy [see warnings and precautions (5.1)] -   gastrointestinal (gi) obstruction [see warnings and precautions (5.7)] -   gastric bypass or stapling surgery -   bowel perforation -   toxic colitis -   toxic megacolon -   hypersensitivity to sodium phosphate salts or any component of monobasic sodium phosphate and dibasic sodium phosphate tablets[see warnings and precautions (5.7)]. risk summary there are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with sodium phosphate. 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. risk summary there are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of monobasic sodium phosphate and dibasic sodium phosphate tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monobasic sodium phosphate and dibasic sodium phosphate tablets and any potential adverse effects on the breastfed child from monobasic sodium phosphate and dibasic sodium phosphate tablets or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the 599 patients in clinical trials receiving at least 48 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. however, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after monobasic sodium phosphate and dibasic sodium phosphate tablets administration. the mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended monobasic sodium phosphate and dibasic sodium phosphate tablets dosage regimen in study 1were 7.0, 7.3, and 8.0 mg/dl, respectively. after monobasic sodium phosphate and dibasic sodium phosphate tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dl, respectively. greater sensitivity of some older individuals cannot be ruled out; therefore, use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in geriatric patients. advise geriatric patients to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets. sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1)]. sodium phosphate is substantially excreted by the kidney. use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1), drug interactions (7.1)] .

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

csl behring australia pty ltd - factor ix, quantity: 1000 iu - injection, powder for - excipient ingredients: phosphate; plasma proteins; antithrombin iii; heparin sodium; sodium; citrate; chloride - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, powder for - excipient ingredients: citrate; heparin sodium; antithrombin iii; sodium; chloride; plasma proteins; phosphate - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - monofix-vf is indicated for the treatment of haemorrhages, for use in minor surgery, and as a prophylaxis in patients with haemophilia b. it has not been evaluated in major surgery. monofix-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels fo these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors. indications as at 14 may 1999: monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because is does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 6000 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; hyprolose; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000 - entecavir-gh is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 1.064 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 1.064 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; hyprolose; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - entecavir-gh is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 3 mg - tablet, modified release - excipient ingredients: hypromellose; calcium hydrogen phosphate; magnesium stearate; silicon dioxide - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.