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

sandoz pty ltd - ramipril, quantity: 1.25 mg - tablet, uncoated - excipient ingredients: sodium bicarbonate; pregelatinised maize starch; hypromellose; microcrystalline cellulose; sodium stearylfumarate - treatment of hypertension. data are currently not available to support the use of ramipril in renovascular hypertension. post mi heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for 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. for 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 >160mmhg or diastolic blood pressure >90mmhg (or on antihypertensive treatment); total cholesterol >5.2mmol/l; hdl cholesterol <0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sandoz pty ltd - carvedilol, quantity: 12.5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; povidone; colloidal anhydrous silica; magnesium stearate; iron oxide yellow; iron oxide red - hypertension. data have not been provided to support the use of this drug in renovascular disease. symptomatic mild to severe (nyha class ii to iv) congestive heart failure (chf) as an adjunct to conventional treatments (e.g diuretics, digoxin, ace inhibitors and vasodilators).

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

sandoz pty ltd - carvedilol, quantity: 6.25 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; povidone; colloidal anhydrous silica; magnesium stearate; iron oxide yellow - hypertension. data have not been provided to support the use of this drug in renovascular disease. symptomatic mild to severe (nyha class ii to iv) congestive heart failure (chf) as an adjunct to conventional treatments (e.g diuretics, digoxin, ace inhibitors and vasodilators).

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

sandoz pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - fluconazole sandoz injection is indicated in adults and children for the following conditions only if fluconazole can not be administered orally. for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral and intravenous therapy has a less favourable ratio of benefits to risks. (see adverse effects.)

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

sandoz pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride - fluconazole sandoz injection is indicated in adults and children for the following conditions only if fluconazole can not be administered orally. for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral and intravenous therapy has a less favourable ratio of benefits to risks. (see adverse effects.)

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

sandoz pty ltd - levetiracetam, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium chloride; water for injections; sodium acetate trihydrate; glacial acetic acid - levetiracetam sandoz concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,levetiracetam sandoz concentrate solution for iv infusion is indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with jme. ? add on therapy in the treatment of pgtc seizures in adults and children from 4 years of age with ige.

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

sandoz pty ltd - buprenorphine, quantity: 40 mg - patch, dermal - excipient ingredients: oleyl oleate; polyethylene; povidone; levulinic acid; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - buprenorphine, quantity: 30 mg - patch, dermal - excipient ingredients: oleyl oleate; polyethylene; povidone; levulinic acid; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - buprenorphine, quantity: 25 mg - patch, dermal - excipient ingredients: oleyl oleate; polyethylene; povidone; levulinic acid; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - erlotinib hydrochloride, quantity: 109.27 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.