Marekani - Kiingereza - NLM (National Library of Medicine)

perrigo company - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 20 mg in 1 ml - estradiol valerate injection is indicated in the: 1.    treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.    treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.  when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3.    treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection should not be used in women with any of the following conditions: 1.    undiagnosed abnormal genital bleeding. 2.    known, suspected, or history of cancer of the breast. 3.    known or suspected estrogen-dependent neoplasia. 4.    active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.    active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial i

Marekani - Kiingereza - NLM (National Library of Medicine)

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.97 mg in 48 [usp'u] - estradiol transdermal system continuous delivery (once-weekly), usp is indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause.  - treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elementa

Marekani - Kiingereza - NLM (National Library of Medicine)

sandoz inc - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - estradiol valerate and estradiol valerate/dienogest is indicated for use by women to prevent pregnancy. the efficacy of estradiol valerate and estradiol valerate/dienogest in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. estradiol valerate and estradiol valerate/dienogest is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. do not prescribe estradiol valerate and estradiol valerate/dienogest to women who are known to have the following: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce w

Marekani - Kiingereza - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system is indicated for: limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol transdermal system - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for estradiol transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition. in general, estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system. the women's health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.3)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.3)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.4)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.4)] .

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

arrotex pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - solution, powder for - excipient ingredients: hydroxypropylbetadex; hydrochloric acid; sodium chloride - voriconazole 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.

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

astrazeneca pty ltd - exenatide, quantity: 2 mg - injection, modified release - excipient ingredients: sucrose; polyglactin - exenatide is indicated for the treatment of type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties - clinical trials for available data on different combinations).

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

eli lilly australia pty ltd - somatropin, quantity: 6 mg (equivalent: somatropin, qty 18 iu) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; glycerol; hydrochloric acid; metacresol - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

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

eli lilly australia pty ltd - somatropin, quantity: 12 mg (equivalent: somatropin, qty 36 iu) - injection, solution - excipient ingredients: hydrochloric acid; metacresol; sodium hydroxide; glycerol; water for injections - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

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

eli lilly australia pty ltd - somatropin, quantity: 24 mg (equivalent: somatropin, qty 72 iu) - injection, solution - excipient ingredients: water for injections; hydrochloric acid; glycerol; sodium hydroxide; metacresol - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

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

organon pharma pty ltd - human chorionic gonadotrophin, quantity: 5000 iu - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; carmellose sodium; mannitol - in the female: sterility due to the absence of follicle-ripening or ovulation.,in the male: hypogonadotrophic hypogonadism. delayed puberty associated with insufficient gonadotrophic pituitary function. cryptorchism, not due to an anatomic obstruction. sterility, in cases of deficient spermatogenesis.