Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
LEVONORGESTREL
BAYER ISRAEL LTD
G03AC03
INTRAUTERINE DELIVERY SYSTEM
LEVONORGESTREL 13.5 MG
INTRAUTERINE
Required
BAYER OY, FINLAND
LEVONORGESTREL
Contraception for up to 3 years.
2020-02-29
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: J601,J605 material-no.: 89482577 PZ: 7621B-V0 code-no.: name: LF-BRO JANESS 13.5MG IUS BLI 1X1 PAT IL country: IL/ARA-ENG-HEB colors: BLACK version: 07.11.2022/01 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 JANESS ® INTRAUTERINE DELIVERY SYSTEM The active ingredient is levonorgestrel 13.5 mg Inactive ingredients and allergens: see section 6 “Further Information”. READ THIS 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. The medicine is not intended for use before the first menstrual bleeding (first menses). 1) WHAT IS THE MEDICINE INTENDED FOR? WHAT IS JANESS? Janess is a T-shaped intrauterine delivery system which slowly releases a small amount of the hormone levonorgestrel after its installation inside the womb. The system is intended for contraception for a period of up to 3 years. Janess works by reducing the monthly growth of the lining of the womb and thickening of the cervical mucosal layer. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm. THERAPEUTIC GROUP: Janess belongs to a group of medicines that contain 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 any of the other ingredients contained in the medicine. For a list of the inactive ingredients, see section 6 “Further Information”. • you are pregnant (see “Pregnancy, breastfeeding and fertility” in section 2). • you have, or have had several time Διαβάστε το πλήρες έγγραφο
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Janess 13.5 mg intrauterine delivery system. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The intrauterine delivery system contains 13.5 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). The product consists of a whitish or pale yellow drug core covered with a semi- opaque membrane, which is mounted on the vertical stem of a T-body. In addition, the vertical stem contains a silver ring located close to the horizontal arms. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown coloured 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. Dimensions of Janess: 28 x 30 x 1.55 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception for up to 3 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Janess is inserted into the uterine cavity and is effective for up to three years. _Insertion and removal/ replacement _ It is recommended that Janess should only be inserted by physicians/ healthcare providers who are experienced in IUS insertions and/or have undergone training on the Janess insertion procedure. Janess is to be inserted into the uterine cavity within seven days of the onset of menstruation. Janess can be replaced by a new system at any time in the cycle. Janess can also be inserted immediately after first trimester abortion. Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than six weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. Page 2 of 20 In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude pe Διαβάστε το πλήρες έγγραφο