Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OESTROGENS,CONJUGATED
PFIZER (MALAYSIA) SDN. BHD.
OESTROGENS,CONJUGATED
14 gm 0 1 Units Units
PF Consumer Healthcare Canada ULC
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PREMARIN ® VAGINAL CREAM Conjugated estrogens (0.625 mg/g) 2 WHAT IS IN THIS LEAFLET 1. What PREMARIN VAGINAL CREAM is used for 2. How PREMARIN VAGINAL CREAM works 3. Before you use PREMARIN VAGINAL CREAM 4. How to use PREMARIN VAGINAL CREAM 5. While you are using it 6. Side effects 7. Storage and Disposal of PREMARIN VAGINAL CREAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PREMARIN VAGINAL CREAM IS USED FOR PREMARIN VAGINAL CREAM is used to treat - atrophic vaginitis (thinning, drying and inflammation of the vaginal walls) - dyspareunia (painful intercourse) - kraurosis vulvae (a condition affecting the female external genitalia, resulting in drying, shriveling and itching of the parts HOW PREMARIN VAGINAL CREAM WORKS PREMARIN VAGINAL CREAM contains a mixture of natural hormones called conjugated estrogens, which are similar to the hormones produced by the ovaries before menopause. When given during or after menopause, they can help control some of the symptoms, such as vaginal itching, dryness, and burning or pain during intercourse. BEFORE YOU USE PREMARIN VAGINAL CREAM - _When you must not use it_ Do not use PREMARIN VAGINAL CREAM: - if you have abnormal uterine bleeding which is not diagnosed - if you have or have had breast cancer, or if you are suspected of having it - if you have or suspected to have abnormal growth which is sensitive to estrogens, such as cancer of the lining of the womb (endometrium) or excessive thickening of the womb lining (endometrial hyperplasia) - if you have or have had a disease caused by blood clots in the arteries, such as a heart attack or stroke or vein, such as in the legs or the lungs; - if you have or have previously had liver disease - if you have a disorder affecting your blood clotting - if you are allergic to estrogen or any of the ingredients found in PREMARIN VAGINAL CREAM _Pregnancy and lactation_ You should stop using PREMARIN VAGINAL CREAM Baca dokumen lengkap
Pfizer Confidential 1 CLD Title : Premarin Vaginal Cream (Conjugated Estrogen) CLD Date : 06 July 2021 Country : Malaysia Reference Document : CDS version 29.0 (dated 15 Apr 2015), USPI (Revised: 09/18) Reason for change : PfLEET number 2021-0070961 (S2): To remove pediatric information related to tablets. Pfizer Confidential 2 1. NAME OF THE MEDICINAL PRODUCT PREMARIN ® VAGINAL CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Premarin ® (conjugated estrogens) Vaginal Cream – Each gram contains 0.625 mg conjugated estrogens, USP. Premarin Vaginal Cream contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α- dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin. 3. PHARMACEUTICAL FORM Cream formulation 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Premarin (conjugated estrogens, CE) Vaginal Cream is indicated in the treatment of atrophic vaginitis, dyspareunia and kraurosis vulvae. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS and SECTION 4.8 UNDESIRABLE EFFECTS). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Use of Premarin Vaginal Cream, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Post-menopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. When estrogen is prescribed for a post-menopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, h Baca dokumen lengkap