Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

kyosomirai pharma co., ltd. - chlormadinone acetate - pale yellow tablet, diameter: approx. 7 mm, thickness: approx. 3 mm

Israel - English - Ministry of Health

tec-o-pharm-libra ltd - chlormadinone acetate; ethinylestradiol - film coated tablets - ethinylestradiol 0.03 mg; chlormadinone acetate 2 mg - etynodiol and estrogen - etynodiol and estrogen - oral hormonal contraceptive.

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate is indicated in combination with prednisone for the treatment of patients with - metastatic castration-resistant prostate cancer (crpc) - metastatic high-risk castration-sensitive prostate cancer (cspc) none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogene

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pahang pharmacy sdn. bhd. - chlormadinone acetate; ethinylestradiol -

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets, usp is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate, usp in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - active deep vein thrombosis, pulmonary embolism or history of these conditions - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

United States - English - NLM (National Library of Medicine)

avkare - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets, usp is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate, usp in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - active deep vein thrombosis, pulmonary embolism or history of these conditions - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

United States - English - NLM (National Library of Medicine)

marlex pharmaceuticals inc - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate, usp is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). - patients with hypercalcemia. pregnancy category   c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions ( 5.1 )] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and deliver

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - leuprolide acetate 5 mg in 1 ml - leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. leuprolide acetate injection is contraindicated in patients known to be hypersensitive to gnrh, gnrh agonist analogs or any of the excipients in leuprolide acetate injection: reports of anaphylactic reactions to gnrh agonist analogs have been reported in the medical literature. leuprolide (loo proe lide) acetate injection read the instructions for use before you start using leuprolide acetate injection and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. your doctor should show you how to draw up leuprolide acetate injection and give the injection the right way before you inject the first time. do not share your syringes with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them.   supplies you will need f

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)

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.