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

sandoz pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole sandoz is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

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

bayer australia ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: povidone; maize starch; lactose monohydrate; colloidal anhydrous silica; magnesium stearate - women:moderately severe to severe signs of androgenization. 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 androgenization.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 cyprostat 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. 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 o

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

strides pharma science 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. cyrotone 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 cyrotone 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. cyrotone 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. cyrotone 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)

sandoz pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 25 mg - tablet, film coated - excipient ingredients: hypromellose; iron oxide black; macrogol 6000; colloidal anhydrous silica; lactose monohydrate; titanium dioxide; croscarmellose sodium; purified talc; microcrystalline cellulose; hyprolose; iron oxide red; magnesium stearate - irbesartan/hct sandoz is indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

sandoz pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 150 mg - tablet, film coated - excipient ingredients: purified talc; hypromellose; lactose monohydrate; iron oxide red; titanium dioxide; microcrystalline cellulose; croscarmellose sodium; iron oxide yellow; macrogol 6000; hyprolose; magnesium stearate; colloidal anhydrous silica - irbesartan/hct sandoz is indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

sandoz pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; lactose monohydrate; hyprolose; titanium dioxide; croscarmellose sodium; colloidal anhydrous silica; macrogol 6000; purified talc; microcrystalline cellulose; iron oxide red; iron oxide yellow - irbesartan/hct sandoz is indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

lundbeck australia pty ltd - zuclopenthixol hydrochloride, quantity: 11.8 mg (equivalent: zuclopenthixol, qty 10 mg) - tablet, film coated - excipient ingredients: copovidone; purified talc; microcrystalline cellulose; lactose monohydrate; glycerol; potato starch; magnesium stearate; hydrogenated castor oil; titanium dioxide; hypromellose; macrogol 6000; iron oxide red - safety related notification and ammended text of the product information approved as described in the letter dated 28 may 2008 from ceu1. (sub#2008-1319-1) clopixol tablets: acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. manic phase of manic depressive illness.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 6.935 mg (equivalent: amlodipine, qty 5 mg); hydrochlorothiazide, quantity: 12.5 mg; olmesartan medoxomil, quantity: 20 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - it is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); hydrochlorothiazide, quantity: 12.5 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - it is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 6.935 mg (equivalent: amlodipine, qty 5 mg); hydrochlorothiazide, quantity: 25 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - it is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.this fixed dose combination is not indicated for initial therapy.