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

sanofi-aventis australia pty ltd - sodium valproate, quantity: 500 mg - tablet, enteric coated - excipient ingredients: hyprolose; calcium silicate; amaranth aluminium lake; titanium dioxide; polyvinyl acetate phthalate; diethyl phthalate; stearic acid; purified talc; povidone; hypromellose; magnesium stearate; macrogol 6000; indigo carmine aluminium lake; citric acid monohydrate - epilepsy: primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy. mania: for the treatment of mania where other therapy has proved inadequate or is inappropriate.

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

sanofi-aventis australia pty ltd - sodium valproate, quantity: 200 mg - tablet, enteric coated - excipient ingredients: citric acid monohydrate; polyvinyl acetate phthalate; indigo carmine aluminium lake; hyprolose; magnesium stearate; povidone; stearic acid; amaranth aluminium lake; diethyl phthalate; purified talc; macrogol 6000; calcium silicate; hypromellose; titanium dioxide - epilepsy: primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy. mania: for the treatment of mania where other therapy has proved inadequate or is inappropriate.

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 10 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; brilliant blue fcf; allura red ac; gelatin; phloxine b - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 5 mg - tablet, uncoated - excipient ingredients: sodium stearylfumarate; calcium sulfate dihydrate; sodium bicarbonate; pregelatinised maize starch - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: sodium stearylfumarate; sodium bicarbonate; calcium sulfate dihydrate; pregelatinised maize starch - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 1.25 mg - tablet, uncoated - excipient ingredients: calcium sulfate dihydrate; pregelatinised maize starch; sodium stearylfumarate; sodium bicarbonate - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

purdue pharma lp - naldemedine tosylate (unii: v1n8f1rvvo) (naldemedine - unii:03ksi6wlxh) - naldemedine .2 mg - symproic is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. symproic is contraindicated in: - patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see warnings and precautions (5.1)]. - patients with a history of a hypersensitivity reaction to naldemedine. reactions have included bronchospasm and rash [see adverse reactions (6.1)] . risk summary there are no available data with naldemedine in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. there is a potential for opioid withdrawal in a fetus when symproic is used in pregnant women [see clinical considerations]. symproic should be used during pregnancy only if the potential benefit justifies

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 10 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; brilliant blue fcf; allura red ac; gelatin; phloxine b - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

arrotex pharmaceuticals pty ltd - ramipril, quantity: 10 mg - tablet, uncoated - excipient ingredients: sodium bicarbonate; calcium sulfate dihydrate; pregelatinised maize starch; sodium stearylfumarate - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. postmyocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmhg or diastolic blood pressure above 90 mmhg (or on antihypertensive treatment); total cholesterol above 5.2mmol/l: hdl cholesterol less than 0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sanovel ilac san. ve tic.a.s. - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)] . developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m2 ) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms of re