Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Levonorgestrel, micronized
Bayer Limited
G02BA; G02BA03
Levonorgestrel, micronized
13.5 milligram(s)
Intrauterine delivery system
Product subject to prescription which may not be renewed (A)
Intrauterine contraceptives; plastic IUD with progestogen
Marketed
2013-02-08
Page 1 of 15 BP22015_REC30367 PACKAGE LEAFLET: INFORMATION FOR THE USER JAYDESS 13.5 MG INTRAUTERINE DELIVERY SYSTEM levonorgestrel This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects, you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. This medicine has been prescribed for you only. Do not pass it on to others. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Jaydess is and what it is used for 2. What you need to know before you use Jaydess 3. How to use Jaydess 4. Possible side effects 5. How to store Jaydess 6. Contents of the pack and other information Page 2 of 15 BP22015_REC30367 1. WHAT JAYDESS IS AND WHAT IT IS USED FOR Jaydess is used for the prevention of pregnancy (contraception) for up to three years. Jaydess is a T-shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel. Jaydess 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE JAYDESS GENERAL NOTES Before you can begin using Jaydess, your healthcare professional will ask you some questions about your personal health history. In this leaflet, several situations are described where Jaydess should be removed, or where the reliability of Jaydess may be decreased. In such situations you should either not have intercourse or you should use a condom or another barrier method. Jaydess, like other hor Прочитајте комплетан документ
Health Products Regulatory Authority 28 April 2023 CRN00DJJ6 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Jaydess 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 Jaydess: 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 Jaydess is inserted into the uterine cavity and is effective for up to three years. _Insertion_ It is recommended that Jaydess should only be inserted by healthcare professionals who are experienced in IUS insertions and/ or have undergone training on the Jaydess insertion procedure. Before insertion, the patient should have been carefully examined in order to detect any contraindication to IUS insertion. Exclude pregnancy before insertion. Consider the possibility of ovulation and conception before using this product. Jaydess is not suitable for use as a post-coital contraceptive (see section 4.3 and se Прочитајте комплетан документ