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

strides pharma science pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: hypromellose; macrogol 400; povidone; microcrystalline cellulose; crospovidone; citric acid monohydrate; polysorbate 80; titanium dioxide; magnesium stearate - raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.

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

eli lilly australia pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: crospovidone; polysorbate 80; magnesium stearate; lactose monohydrate; lactose; povidone; carnauba wax; colour; propylene glycol; indigo carmine; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; industrial methylated spirit; ethanol - evista is indicated for the prevention and treatment of osteoporosis in post-menopausal women. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

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

arrotex pharmaceuticals pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; polysorbate 80; povidone; microcrystalline cellulose; magnesium stearate; glycine; titanium dioxide; hypromellose; carnauba wax; macrogol 400 - raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.,raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis.raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

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

generic health pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; poloxamer; calcium hydrogen phosphate dihydrate; citric acid monohydrate; sodium starch glycollate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - raloxifene gh is proposed to be used for:,1. the prevention and treatment of osteoprosis in post-menopausal women,2. the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis,3. the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer,high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

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

bayer australia ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; maize starch; colloidal anhydrous silica; povidone - 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 androcur 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 of drive in sexual deviations androcur 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 pre-requisite for therapy is the desire by the patient for treatment.androcur 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)

arrotex pharmaceuticals 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. apo-cyproterone acetate 50mg 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 apo-cyproterone acetate 50mg 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 ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. apo-cyproterone acetate 50mg 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. apo-cyproterone acetate 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of 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)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of postmenopausal oestrogen deficiency (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of kliogest should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. see precautions and dosage and administration. kliogest is for use in postmenopausal women with an intact uterus. in perimenopausal women treated with kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.

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

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 30 microgram; levonorgestrel, quantity: 150 microgram - tablet, film coated - excipient ingredients: povidone; magnesium stearate; lactose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - oral contraception.

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

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 100 microgram; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: gelatin; macrogol 4000; magnesium stearate; maize starch; lactose monohydrate; titanium dioxide; hypromellose - oral contraception

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

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: gelatin; hypromellose; iron oxide yellow; titanium dioxide; magnesium stearate; lactose monohydrate; maize starch; macrogol 4000 - oral contraception