Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levonorgestrel
Bayer Plc
G03AC03
Levonorgestrel
20microgram/24hour
Intrauterine device
Intrauterine
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 07030203; GTIN: 5016703006183
PIL v 025_0 Page 1 of 10 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. _ _ DATE OF INSERTION = X SPOTTING = ○ BLEEDING = ● MONTH 1 MONTH 2 MONTH 3 MONTH 4 MIRENA ® 20 MICROGRAMS/24 HOURS INTRAUTERINE DELIVERY SYSTEM (LEVONORGESTREL) PATIENT INFORMATION BOOKLET Patient Name: Date of Fitting: Doctor’s Name: Telephone No: First check-up visit: Next visits: 1. 2. 3. 4. 5. PIL v 025_0 Page 2 of 10 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 _page number_ 2. BEFORE YOU HAVE MIRENA FITTED _page number_ 3. HOW AND WHEN MIRENA IS USED _page number_ 4. POSSIBLE SIDE EFFECTS _page number_ 5. FURTHER INFORMATION _page number_ 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 ar Přečtěte si celý dokument
OBJECT 1 MIRENA Summary of Product Characteristics Updated 12-Apr-2018 | Bayer plc 1. Name of the medicinal product Mirena ® 20 micrograms/24 hours intrauterine delivery system 2. Qualitative and quantitative composition Levonorgestrel 52mg. The initial release of levonorgestrel is approximately 20 micrograms per day. For details of release rates, see section 5.2. For a full list of excipients, see section 6.1 3. Pharmaceutical form Levonorgestrel-releasing intrauterine system (IUS). The product consists of an inserter and levonorgestrel intrauterine system, which is loaded at the tip of the inserter. Inserter components are an insertion tube, plunger, flange, body and slider. The system consists of a white or almost white hormone-elastomer core, mounted on a T-body and covered in opaque tubing, which regulates the release of levonorgestrel. The white T-body has a loop at one end and two 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. 4. Clinical particulars 4.1 Therapeutic 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 Posology and method of administration _STARTING TREATMENT_ • Contraception and idiopathic menorrhagia In women of fertile age, Mirena is inserted into the uterine cavity within seven days of the onset of menstruation. It can be replaced by a new system at any time of the cycle. Post-partum insertion: To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery. If the patient is experiencing significant post-partum bleeding and/or pain then infection or other causes should be excluded before insertion. Mirena can also be inserted immediately after the first trimester abortion. Mirena is Přečtěte si celý dokument