Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
ESTRADIOL VALERATE
BAYER (SOUTH EAST ASIA) PTE LTD
G03CA03
2 mg
TABLET, SUGAR COATED
ESTRADIOL VALERATE 2 mg
ORAL
Prescription Only
Bayer Weimar GmbH und Co. KG
ACTIVE
1990-05-23
Progynova 1& 2 mg PI_SG_CCDS 11_20 Dec 2011 1. NAME OF THE MEDICINAL PRODUCT Progynova 1mg Progynova 2mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each beige sugar-coated tablet contains estradiol valerate 1.0 mg. Each blue sugar-coated tablet contains estradiol valerate 2.0 mg 3. PHARMACEUTICAL FORM Sugar-coated tablets 4. CLINICAL PARTICULARS 4.1 INDICATIONS 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 If the patient has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen (see below, “Combination regimen”) should begin within the first 5 days of menstruation. Patients with amenorrhea or very infrequent periods or who are post-menopausal, may start a combination regimen (see below, “Combination regimen”) at any time, provided pregnancy has been excluded. Estrogen 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 women. _ _ 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 tablet Progynova 1.0mg tablet (or one blue tablet Progynova 2.0mg tablet ) is taken daily. ADMINISTRATION Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack follows immediately without a break. Progynova 1& 2 mg PI_SG_CCDS 11_20 Dec 2011 The tablets are to be swallowed whole with some liquid. The ta Read the complete document
Progynova 2 mg PI_SG_CCDS 12_04 HSA HRTs Safety Updates_Sep 2023 RESTRICTED 1. NAME OF THE MEDICINAL PRODUCT Progynova 1mg Progynova 2mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each beige sugar-coated tablet contains estradiol valerate 1.0 mg. Each white sugar-coated tablet contains estradiol valerate 2.0 mg 3. PHARMACEUTICAL FORM Sugar-coated tablets 4. CLINICAL PARTICULARS 4.1 INDICATIONS 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 Hormonal contraception should be stopped when HRT is started and the patient should be advised to take non-hormonal contraceptive precautions, if required. 4.2.3 HOW TO START PROGYNOVA 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 post-menopausal, may start a combination regimen (see section “Combination regimen”) at any time, provided pregnancy has been excluded. Estrogen 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 women. _ _ 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 tablet Progynova 1.0mg tablet (or one white tablet Progynova 2.0mg tablet ) is taken daily. Progynova 2 mg PI_SG_CCDS 12_04 HSA HRTs Safety Updates_Sep 2023 RESTRICTED ADMINISTRATION Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid. The tablets Read the complete document