البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
LEVONORGESTREL
BAYER ISRAEL LTD
G03AC03
INTRAUTERINE DELIVERY SYSTEM
LEVONORGESTREL 19.5 MG
INTRAUTERINE
Required
BAYER OY, FINLAND
LEVONORGESTREL
Contraception for up to 5 years
2023-11-30
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: J601,J605 material-no.: 89641675 PZ: 7621B-V0 code-no.: name: LF-BRO KYLEENA 19.5MG IUS BLI 1X1 PAT IL country: IL/ARA-ENG-HEB/BAG colors: BLACK version: 01.03.2023/01 Restricted Document dimension: 72 X 145 MM page: 2 / 2 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only KYLEENA® INTRAUTERINE DELIVERY SYSTEM The intrauterine delivery system contains: 19.5 mg levonorgestrel. Inactive ingredients and allergens in this medicine - see section 6 “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. Kyleena is not indicated for use before the first menstrual bleeding (menarche) and is not indicated for use in postmenopausal women. 1. WHAT IS THE MEDICINE INTENDED FOR? WHAT IS KYLEENA? Kyleena is used for the prevention of pregnancy (contraception) for up to five years. Kyleena is a T-shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel. Kyleena works by reducing the monthly growth of the lining of the womb and thickening the cervical mucus. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm. THERAPEUTIC GROUP: Kyleena belongs to a group of medicines containing the female hormone progestogen. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to the active ingredient levonorgestrel or to any of the other ingredients contained in the medicine. For the list of inactive ingredients, see section 6 “Further Information”. • you are pregnant (see in sec اقرأ الوثيقة كاملة
RESTRICTED SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kyleena 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The intrauterine delivery system contains 19.5 mg levonorgestrel. For the full list of excipients, see section 6.1. For details of release rates, see section 5.2. 3. PHARMACEUTICAL FORM Intrauterine delivery system (IUS). Dimensions of Kyleena: 28 x 30 x 1.55 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception for up to 5 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Kyleena is inserted into the uterine cavity and is effective for up to 5 years. _Insertion and removal/replacement _ _ _ It is recommended that Kyleena should only be inserted by physicians/healthcare professionals who are experienced in IUS insertions and/ or have undergone training on the Kyleena insertion procedure. Kyleena is to be inserted into the uterine cavity within 7 days of the onset of menstruation. Kyleena can be replaced by a new system at any time in the cycle. Kyleena can also be inserted immediately after first trimester abortion. Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/ or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate steps should be taken, such as physical examination and ultrasound. Physical examination may not be sufficient to exclude partial perforation. Kyleena can be distinguished from other IUSs by the combination of the visibility of the silver ring on RESTRICTED ultrasound and the blue colour of the removal threads. The T-frame of Kyleena contains barium sulfate which makes it visible in X-ray examination. Kyleena is removed by gently pulling on the threads with a forceps. If the threads are not visible and the system is found to be in the uterine cavity on ultrasound examination, it m اقرأ الوثيقة كاملة