Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Levonorgestrel
Imbat Limited
G02BA; G02BA03
Levonorgestrel
52 milligram(s)
Intrauterine delivery system
Product subject to prescription which may be renewed (B)
Intrauterine contraceptives; plastic IUD with progestogen
Authorised
2017-10-27
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER MIRENA ® 52MG INTRAUTERINE DELIVERY SYSTEM Levonorgestrel Your medicine is available using the name Mirena 52mg Intrauterine Delivery System but will be referred to as Mirena throughout the leaflet. Patient name: Date of fitting: Doctor’s Name: Telephone No: First check-up visit: Next visits: 1. 2. 3. 4. 5. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU DECIDE TO HAVE MIRENA FITTED 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 nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Mirena is and what it is used for 2. What you need to know before you have Mirena fitted 3. How and when Mirena is used 4. Possible side effects 5. How to store Mirena 6. Contents of the pack and other information 1. WHAT MIRENA IS AND WHAT IT IS USED FOR Mirena is an intrauterine system (IUS) placed inside the womb (uterus) where it slowly releases the hormone Levonorgestrel. It can be used in the following three ways: 1. As an effective long-term and reversible method of CONTRACEPTION. 2. For REDUCING MENSTRUAL BLOOD FLOW, so it can be used if you suffer from heavy periods (heavy menstrual bleeding). This is called menorrhagia. It can be used for contraception and reducing menstrual blood flow until it is removed or up to a maximum of 5 years. 3. If you are going through the MENOPAUSE, a gradual process which usually takes place between the ages of about 45 and 55. Oestrogens can be taken to relieve menopausal symptoms. However, taking oestrogens alone increases the risk of abnormal growth or cancer of the lining of the womb (_endometrial hyperplasia_). Using a progestogen such as Mirena in combination with oestrogen replacement therapy lowers this risk. _Children and adolescents _ Mirena is not indicated for use before the first menstr Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirena 52 mg Intrauterine Delivery System 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levonorgestrel 52 mg The in-vivo dissolution rate is about 20 µg/24 hours initially and is reduced to about 11 µg/24 hours after five years. The mean dissolution rate of levonorgestrel is about 14 µg/24 hours over the time up to five years. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Intrauterine delievry system. _Product imported from France_ The levonorgestrel intrauterine delivery system consists of a white or almost white drug core covered with an opaque membrane, which is mounted on the vertical stem of a T-body. The T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Removal threads are attached to the loop. The vertical stem of the intrauterine delivery system is loaded in the insertion tube at the tip of the inserter. 4 CLINICAL PARTICULARS As per PA1410/008/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/008/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Polydimethylsiloxane elastomer Polydimethylsiloxane tubing Polyethylene Barium sulfate Iron oxide 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 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_ _ _ _3_ _1_ _/_ _1_ _0_ _/_ _2_ _0_ Přečtěte si celý dokument