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

alphapharm pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 43.376 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: hyprolose; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; sodium carbonate; magnesium stearate; pregelatinised maize starch; arginine; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see section 5.1 pharmacodynamic properties, clinical trials, atorvastatin component, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 10.844 mg (equivalent: atorvastatin, qty 10 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: sodium carbonate; microcrystalline cellulose; arginine; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; hyprolose; pregelatinised maize starch; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see section 5.1 pharmacodynamic properties, clinical trials, atorvastatin component, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; arginine; microcrystalline cellulose; hyprolose; sodium carbonate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see section 5.1 pharmacodynamic properties, clinical trials, atorvastatin component, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

lupin australia pty limited - risperidone, quantity: 4 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide red - risperidone tablet is indicated for the treatment of schizophrenia and related psychoses. risperidone tablet is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperidone tablet is indicated for the treatment of behavioural disturbances in dementia. risperidone tablet is indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. risperidone tablet is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

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

lupin australia pty limited - risperidone, quantity: 3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide yellow - risperidone tablet is indicated for the treatment of schizophrenia and related psychoses. risperidone tablet is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperidone tablet is indicated for the treatment of behavioural disturbances in dementia. risperidone tablet is indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. risperidone tablet is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

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

lupin australia pty limited - risperidone, quantity: 2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; sunset yellow fcf aluminium lake - risperidone tablet is indicated for the treatment of schizophrenia and related psychoses. risperidone tablet is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperidone tablet is indicated for the treatment of behavioural disturbances in dementia. risperidone tablet is indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. risperidone tablet is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

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

lupin australia pty limited - risperidone, quantity: 1 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol - risperidone tablet is indicated for the treatment of schizophrenia and related psychoses. risperidone tablet is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperidone tablet is indicated for the treatment of behavioural disturbances in dementia. risperidone tablet is indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. risperidone tablet is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

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

cipla australia pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism. moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe andogenetic alopecia). moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. it is thus possible to treat diseases in women caused either by increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. this also promotes regular menstruation. . men: reduction of drive in sexual deviations. cyproterone reduces the force of the sexual urge in men with sexual deviations. whilst under treatment, the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. inoperable prostatic carcinoma. to suppress "flare" with initial lhrh analogue therapy. in long term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred. in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

amneal pharma australia pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone an inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone an is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. cyproterone an reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone an should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 5 mg - tablet, dispersible - excipient ingredients: butylated hydroxytoluene; crospovidone; hypromellose; lactose monohydrate; mannitol; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica - afinitor is indicated for the: ? treatment of postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin. ? treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (net) of gastrointestinal or lung origin in adults. ? treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? treatment of subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. ? treatment of patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery. ? adjunctive treatment of patients aged 2 years and older with tsc and associated refractory seizures.