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

bayer australia ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. because of its anti-androgenic effect androcur is indicated for the treatment of inoperable prostatic carcinoma in patients who have failed primary hormonal manipulation or who are at risk from cardiovascular disease and/or who are intolerant of oestrogen therapy. indications as at 1 june 1995: 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)

bayer australia ltd - ethinylestradiol, quantity: 30 microgram; levonorgestrel, quantity: 150 microgram - tablet, sugar coated - excipient ingredients: sucrose; macrogol 6000; povidone; lactose monohydrate; glycol montanate; maize starch; purified talc; calcium carbonate; magnesium stearate - for the control of conception.

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

bayer australia ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, sugar coated - excipient ingredients: povidone; calcium carbonate; maize starch; sucrose; lactose monohydrate; macrogol 6000; purified talc; magnesium stearate; glycol montanate - diane-35 ed is indicated for: the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. diane-35 will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications).,if the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.

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

bayer australia ltd - estradiol valerate, quantity: 2 mg - tablet, sugar coated - excipient ingredients: magnesium stearate; macrogol 6000; sucrose; glycol montanate; calcium carbonate; povidone; maize starch; lactose monohydrate; purified talc - indications as at 19 july 2004: short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. progynova has also a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - estradiol, quantity: 5.69 mg - drug delivery system, transdermal - excipient ingredients: ethyl oleate; isopropyl myristate; glyceryl laurate; acrylates/acrylamide copolymer - other conditions: do not remove from primary pack except for immediate use. for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal 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. lifestyle modifications and the risk benefit profile of climara 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 sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

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

bayer australia ltd - estradiol, quantity: 1.97 mg - drug delivery system, transdermal - excipient ingredients: glyceryl laurate; ethyl oleate; isopropyl myristate; acrylates/acrylamide copolymer - other condition: do not remove from primary pack except for immediate use. for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal 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. lifestyle modifications and the risk benefit profile of climara 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 sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

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

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; levonorgestrel, quantity: 100 microgram - tablet, sugar coated - excipient ingredients: calcium carbonate; maize starch; povidone; glycol montanate; lactose monohydrate; macrogol 6000; magnesium stearate; sucrose; purified talc - microlevlen ed is indicated for the prevention of pregnancy.

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

bayer australia ltd - estradiol, quantity: 7.6 mg - drug delivery system, transdermal - excipient ingredients: isopropyl myristate; ethyl oleate; glyceryl laurate; acrylates/acrylamide copolymer - other conditions: do not remove from primary pack except for immediate use. indications: for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal 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. lifestyle modifications and the risk benefit profile of climara 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 sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

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

bayer australia ltd - estradiol, quantity: 3.8 mg - drug delivery system, transdermal - excipient ingredients: isopropyl myristate; glyceryl laurate; ethyl oleate; acrylates/acrylamide copolymer - other conditions: do not remove from primary pack except for immediate use. indications: for short term treatment of the signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal 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. lifestyle modifications and the risk benefit profile of climara 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 sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.