Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESTRADIOL VALERATE
BAYER CO. (MALAYSIA) SDN. BHD.
ESTRADIOL VALERATE
28Tablet Tablets
Bayer Weimar GmbH und Co. KG
PROGYNOVA 28 Corporate Patient Information Page: 1 of 9 valid as per:17.03.2006 THE NAME OF YOUR MEDICATION IS: PROGYNOVA 28 Dear Patient, Please read this leaflet carefully before you start using Progynova 28. This leaflet will provide information about the benefits and risks of using Progynova 28. It will also advise you about how to take Progynova 28 properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist. This product has been prescribed for you personally and you should not pass it on to others. WHAT DOES PROGYNOVA 28 CONTAIN? (COMPOSITION) Each blister pack of Progynova 28 contains 28 tablets, each containing 1.0 mg estradiol valerate or 2.0 mg estradiol valerate as active substance. Progynova 28 also contains the following other ingredients: lactose monohydrate; maize starch; polyvidone 25 000; talc; magnesium stearate; sucrose; polyvidone 700 000; macrogol 6 000; calcium carbonate; glycerol 85 %; titanium dioxide; ferric oxide pigment, yellow; indigo carmine lake; montanglycol wax. WHAT IS PROGYNOVA 28? (PHARMACEUTICAL FORM AND PHARMACO-THERAPEUTIC GROUP) Progynova 28 is a sugar-coated tablet for hormone replacement therapy (HRT). WHAT PACK SIZES OF PROGYNOVA 28 ARE AVAILABLE?HOW DOES PROGYNOVA 28 WORK? (PROPERTIES OF PREPARATION) Progynova 28 contains estradiol valerate, a prodrug of the natural human estradiol. During the climacteric ('the change of life') the estradiol production of the ovaries declines. Although the change of life is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries. In addition the loss of these hormones may, in some women, lead to thinning of the bones in later life (postmenopausal osteoporosis). Progynova 28 replaces the hormone estradiol that the body no longer makes. The estradiol prevents or relieves troublesome symptoms (climacteric complaint সম্পূর্ণ নথি পড়ুন
Reference : Progynova / Film-coated tablets / CCDS / Version 1213+ 14 / 14 Jul 201513 Apr 2021 RESTRICTED PROGYNOVA ® 1 mg and 2 mg Film-Coated Tablets 1. NAME OF THE MEDICINAL PRODUCT Progynova 1 mg coated tablets Progynova 2 mg coated tabletsTablet 1mg and 2mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each beige coated tablet contains estradiol valerate 1.0 mg Each white coated tablet contains estradiol valerate 2.0 mg 3. PHARMACEUTICAL FORM Coated tablets 4. CLINICAL PARTICULARS 4.1 INDICATION(S) Hormone replacement therapy (HRT) for the treatment of signs and symptoms of estrogen deficiency due to natural menopause or castration. Prevention of postmenopausal osteoporosis. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 DOSAGE REGIMEN ► How to start Progynova Hysterectomized patients may start at any time. If the patient has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen (see section ‘Combination regimen’) should begin within the first 5 days of menstruation. Patients with amenorrhea or very infrequent periods or who are postmenopausal, may start a combination regimen (see section ‘Combination regimen’) at any time, provided pregnancy has been excluded. Change from other HRT (cyclic, sequential, or continuous combined) Women changing from other HRT should complete the current cycle of therapy before initiating Progynova therapy. ► Dosage One beige Progynova tablet 1.0 mg (or one white Progynova tablet 2.0 mg) is taken daily. ► Administration Each pack covers 28 days of treatment. Treatment is continuous HRT, which means that the next pack follows immediately without a break. Combination regimen: In women with intact uterus, the concomitant use of an appropriate progestogen is advised for 10-14 days every 4 weeks (continuous sequential or cyclic HRT) or with each tablet of estrogen (continuous combined HRT). Adequate provision should be made by the physician to facilitate and assure a proper compliance of সম্পূর্ণ নথি পড়ুন