Страна: Мальта
мова: англійська
Джерело: Medicines Authority
ESTROGENS CONJUGATED
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
G03CA57
ESTROGENS CONJUGATED 0.625 mg/g
CREAM
ESTROGENS CONJUGATED 0.625 mg/g
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2006-11-20
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER PREMARIN* VAGINAL CREAM Conjugated Estrogens READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Premarin Vaginal Cream is and what it is used for 2. Before you use Premarin Vaginal Cream 3. How to use Premarin Vaginal Cream 4. Possible side effects 5. How to store Premarin Vaginal Cream 6. Further information 1. WHAT PREMARIN VAGINAL CREAM IS AND WHAT IT IS USED FOR Premarin Vaginal Cream is an estrogen-only HRT. It contains a mixture of natural hormones called conjugated estrogens. _ _ Premarin Vaginal Cream is one of a group of medicines known as Hormone Replacement Therapy (HRT). It is used to treat some of the symptoms and conditions associated with the menopause. Estrogen is one of the main hormones responsible for helping to keep many of the tissues in the body healthy, such as the tissues of the urinary system and the lining of the vagina. During the menopause, the level of the estrogen in your body will decrease. By replacing the estrogen that your body no longer produces, Premarin Vaginal Cream can relieve some of the symptoms that you may experience at this time, such as vaginal itching and dryness Прочитайте повний документ
Page 1 of 12 PREMARIN* VAGINAL CREAM 1. NAME OF THE MEDICINAL PRODUCT Premarin * Vaginal Cream. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 gram of the cream contains 0.625 mg conjugated estrogens USP. 3. PHARMACEUTICAL FORM Cream for intravaginal or topical administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Short-term treatment of atrophic vaginitis and post-menopausal atrophic urethritis, kraurosis vulvae. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The usual recommended dose is 1 to 2g daily administered intravaginally or topically to the vaginal area, depending on the severity of the condition. The applicator has dosage markings showing how much of the cream is equivalent to 1g or 2g to help you with applying the correct amount of cream. The following ‘Instruction for Use’ should be given to the patient and are included in the Patient Information Leaflet: To apply the cream into the vagina, the applicator should be used as follows: 1. Remove the cap from the aluminium tube of cream and screw the nozzle end of the applicator onto the tube. 2. Gently squeeze the tube to force the cream into the barrel of the applicator. Depending on the dose your doctor advised you to use, fill the applicator with cream up to the appropriate dosage marking. 3. Unscrew the filled applicator from the tube of cream and replace the cap on the tube. 4. To apply the cream, gently insert the applicator into your vagina and then press the plunger back to its original position. 5. After use, remove the empty applicator. To clean the applicator after use, pull the plunger out from th Прочитайте повний документ