Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
LEVONORGESTREL
BAYER (SOUTH EAST ASIA) PTE LTD
G03AC02
52 mg
INTRAUTERINE DEVICE
LEVONORGESTREL 52 mg
INTRAUTERINE
Prescription Only
BAYER OY
ACTIVE
1994-11-15
1 Mirena IUS PIL_SG_CCPI 27_28 Feb 2023 2 Mirena IUS PIL_SG_CCPI 27_28 Feb 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER Mirena 20 micrograms/24 hours intrauterine delivery system Levonorgestrel 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 any further questions, 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT MIRENA IS AND WHAT IS IT USED FOR ......................... 3 2. BEFORE YOU USE MIRENA ............................................................ 3 3. HOW TO USE MIRENA.................................................................... 11 4. POSSIBLE SIDE EFFECTS ............................................................... 17 5. HOW TO STORE MIRENA .............................................................. 20 6. FURTHER INFORMATION ............................................................. 20 1. WHAT MIRENA IS AND WHAT IS IT USED FOR Mirena is a T-shaped intrauterine delivery system (IUS) which after insertion releases the hormone levonorgestrel into the womb. The purpose of the T-body is to adjust the system to the shape of the womb. The vertical arm of the white T-body carries a drug reservoir containing levonorgestrel. Two brown colored removal threads are tied to the loop at the lower end of the vertical arm. Mirena is used for • Contraception (prevention of pregnancy), 3 Mirena IUS PIL_SG_CCPI 27_28 Feb 2023 • Idiopathic menorrhagia (excessive menstrual bleeding) • Protection from endometrial hyperplasia (excessive growth of the lining of the womb) during estrogen replacement therapy. 2. BEFORE YOU USE MIRENA GENERAL NOTES Before you can begin using Mirena, your doctor will ask you some questions ab read_full_document
Mirena IUS PI_SG_CCDS 27.1_31 Oct 2023 1. NAME OF MEDICINAL PRODUCT Mirena 20 micrograms/24 hours intrauterine delivery system 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levonorgestrel 52mg. The average in vivo release rate is 20 micrograms/day during the first year. For a 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 white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown removal threads are attached to the loop. The T-frame of Mirena contains barium sulphate, which makes it visible in X-ray examination. 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 INDICATIONS Contraception. Idiopathic menorrhagia. Mirena may be particularly useful in women with idiopathic menorrhagia requiring (reversible) contraception. Protection from endometrial hyperplasia during oestrogen replacement therapy. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Mirena is inserted into the uterine cavity. It is effective for 8 years for contraception and for 5 years in the indication idiopathic menorrhagia In the indication for the protection from endometrial hyperplasia during oestrogen replacement therapy, clinical data beyond 4 years of use are limited. Mirena should therefore be removed after 4 years. For timing regarding removal/replacement see section ‘Removal/Replacement’. The in vivo levonorgestrel release rate 24 days after insertion is approximately 21 μg/day, decreasing continuously to approximately 19 μg/day after 1 year, to 11 μg/day after 5 years and to 7 μg/day after 8 years of use. The average daily levonorgestrel release rates are approximately 20 μg/day during the first year read_full_document