Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Progesterone
Imbat Limited
G03DA; G03DA04
Progesterone
8 percent
Vaginal gel
Product subject to prescription which may not be renewed (A)
Pregnen (4) derivatives; progesterone
Authorised
2014-08-15
Page 1 of 2 CRINONE ® 8% W/W PROGESTERONE VAGINAL GEL (progesterone) PATIENT INFORMATION LEAFLET Your medicine is available using the name Crinone 8% w/w progesterone vaginal gel but will be referred to as Crinone throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT CRINONE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CRINONE 3. HOW TO USE CRINONE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CRINONE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CRINONE IS AND WHAT IT IS USED FOR Crinone contains progesterone and is used for the treatment of infertility due to a deficiency of the female hormone progesterone during the menstrual cycle. During the menstrual cycle, an egg develops in the ovary during the first 14 days. This is called the follicular phase of the menstrual cycle. Ovulation then occurs and leaves a corpus luteum in the ovary. This is called the luteal phase of the menstrual cycle. This corpus luteum produces progesterone for 12-16 days which helps to thicken and maintain the lining of the uterus (womb) ready for a fertilised egg. If fertilisation of the egg does not occur, the progesterone level falls and the lining of the uterus is shed (menstruation). If the egg is fertilised and the embryo implants in the lining of the uterus, the corpus luteum continues to produce progesterone to support the pregnancy until the embryos placenta takes over at 10 weeks into the pregnancy. In some women the progesterone produced i Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crinone 8% w/w progesterone vaginal gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Contains sorbic acid For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal gel _Product imported from the UK & Czech Republic:_ White to off white gel contained in a white plastic applicator. 4 CLINICAL PARTICULARS As per PA0654/021/001. 5 PHARMACOLOGICAL PROPERTIES As per PA0654/021/001. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Glycerin Light Liquid Paraffin Hydrogenated Palm Oil Glycerides Carbomer 974P Sorbic acid Polycarbophil Sodium hydroxide Purified water 6.2 INCOMPATIBILITIES No incompatibilities were found with the usual contraceptive devices. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the foil overwraps and outer carton of the product as marked in the country of origin. Active Ingredient Mg/dose % w/w Progesterone 90 8.0 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _3_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _1_ _6_ _3_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Do not freeze. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing single use, one piece applicators in foil overwraps. Pack size: 15 applicators 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUC Прочитать полный документ