Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
LEVONORGESTREL
Bayer PLC
G02BA03
LEVONORGESTREL
INTRAUTERINE DELIVERY SYSTEM
LEVONORGESTREL 52 mg
POM
OTHER GYNECOLOGICALS
Authorised
2005-05-30
Patient Information Booklet Patient Name: Date of Fitting: Doctor's Name: Telephone No: First check-up visit: Next visits: 1. 2. 3. 4. 5. 20 micrograms/24 hours intrauterine delivery system (levonorgestrel) 85213997 JT JOB NO.: 300796 ITEM NO.: 85213997 DRAWN UP/OS: DATE: 16.3.2016 CLIENT: Bayer Oy FOLDING: DIMENSIONS (MM): 72 x 145 NUMBER OF PAGES: 20 FONT / FONT SIZE / SPACING: BayerSans 9 pt / 9,9 pt COLORS: 2/2 Pms 321, black PHARMACODE: 1731 300796 85213997 Potilasohje Mirena EVP GB vedos.indd 1 16.3.2016 7.10 {2) (3} ABOUT THIS BOOKLET Please read this booklet carefully before you decide to have Mirena fitted. It provides you with some useful information about Mirena. The information in this booklet applies only to Mirena. If you have any questions or are not sure about anything, please ask your doctor or nurse. IN THIS BOOKLET: 1. What Mirena is and what it is used for .... 2 2. Before you have Mirena fitted .................... 5 3. How and when Mirena is used .................10 4. Possible side effects .....................................14 5. Further information ....................................18 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, if you suffer from heavy periods (HEAVY MENSTRUAL BLEEDING). It can be used for contraception and heavy menstrual bleeding until it is removed or up to a maximum of 5 years. 3. If you are going through the menopause Mirena can be used in conjunction with an oestrogen as part of a HORMONE REPLACEMENT THERAPY (HRT) REGIMEN to protect the lining of your womb. Not so much is known about how well Mirena protects the lining of the womb beyond 4 years of use in women who are taking oestrogen to treat menopausal symptoms. Therefore, if you are using it in this way, your doctor or nurse will remove your Διαβάστε το πλήρες έγγραφο
1 of 13 1. NAME OF THE MEDICINAL PRODUCT Mirena 20 micrograms/24 hours intrauterine delivery system 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each intrauterine delivery system contains 52 mg of levonorgestrel. The initial release rate is 20 micrograms/24 hours. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Intrauterine delivery system (IUS) The levonorgestrel (LNG) IUS 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 IUS is loaded in the insertion tube at the tip of the inserter. The IUS and inserter are essentially free of visible impurities. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception Idiopathic menorrhagia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION SPECIAL POPULATIONS Children and adolescents Safety and efficacy of Mirena have been established in women of reproductive age. There is no relevant indication for the use of Mirena before menarche. Geriatric patients Mirena has not been studied in women over the age of 65 years. Patients with hepatic impairment Mirena has not been studied in women with acute liver disease or liver tumors, see 4.3 Contraindications. Patients with renal impairment 2 of 13 Mirena has not been studied in women with renal impairment. Method of administration Mirena is inserted into the uterine cavity and is effective for five years. The in vivo dissolution rate is approximately 20 micrograms/24 hours initially and is reduced to 10 micrograms/24 hours after five years. The mean dissolution rate of levonorgestrel is about 14 micrograms/24 hours over the time up to five years. Mirena, when inserted according to the insertion instructions (see separate document 'Insertion instructions'), has a failure rate of approximately 0.2% at 1 year and a cumulative failure rate Διαβάστε το πλήρες έγγραφο