국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
estradiol valerate, Quantity: 2 mg
Bayer Australia Ltd
Tablet, sugar coated
Excipient Ingredients: magnesium stearate; macrogol 6000; sucrose; glycol montanate; calcium carbonate; povidone; maize starch; lactose monohydrate; purified talc
Oral
2 x 28 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: White sugar coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-02-06
PROGYNOVA® CMI Vx0.1 1 PROGYNOVA® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING PROGYNOVA®? PROGYNOVA® contains the active ingredient estradiol valerate. PROGYNOVA® provides hormone replacement therapy (HRT) for the treatment of menopausal complaints after the cessation of monthly bleeding, after surgical removal of the ovaries (oophorectomy) or due to radiotherapy. For more information, see Section 1. Why am I using PROGYNOVA®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PROGYNOVA®? Do not use if you have ever had an allergic reaction to estradiol valerate or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use PROGYNOVA®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PROGYNOVA® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE PROGYNOVA®? Take one tablet at the same time each day. Swallow the tablets whole with a glass of water. More instructions can be found in Section 4. How do I use PROGYNOVA®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PROGYNOVA®? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using PROGYNOVA®. • If you become pregnant while taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not take PROGYNOVA® to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • Be 전체 문서 읽기
PROGYNOVA PI V1.0, CCDS 14 1 AUSTRALIAN PRODUCT INFORMATION PROGYNOVA ® (ESTRADIOL VALERATE) TABLETS WARNING Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens (0.625 mg) relative to placebo (see Clinical trials and 4.4 Special warnings and precautions for use). The WHI study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogen s (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see Clinical trials and 4.4 Special warnings and precautions for use). The Women’s Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see Clinical trials and 4.4 Special warnings and precautions for use). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 NAME OF THE MEDICINE Estradiol valerate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PROGYNOVA 1 mg: each tablet contains 1 mg estradiol valerate. PROGYNOVA 2 mg: each tablet conta 전체 문서 읽기