Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levonorgestrel
Bayer Oy
G02BA03
levonorgestrel
52mg
intrauterine delivery system
(1) in blister
Prescription
Registered
2019-12-24
1/13 RESTRICTED (Translation from Finnish / Bayer Oy / Linguistic Services / SK / April 28, 2016) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mirena 20 micrograms/24 hours intrauterine delivery system 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One intrauterine delivery system contains 52 mg of levonorgestrel. The initial release rate is about 20 micrograms / 24 hours. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intrauterine delivery system (IUS) The IUS consists of a white or almost white hormone-elastomer core covered with an opaque membrane and mounted on the vertical arm of the T-body. The T-body has a loop at one end and two horizontal arms at the other end. Two removal threads are attached to the loop. The vertical arm of the IUS is inside the insertion tube. The IUS is free of impurities. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception, idiopathic menorrhagia, hypermenorrhea, dysmenorrhea, and local progestogen treatment during estrogen replacement therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Mirena is inserted into the uterine cavity and is effective for five years. Mirena should only be inserted by healthcare professionals who are experienced in Mirena insertions or have undergone sufficient training for Mirena insertion. Mirena as a contraceptive Mirena is inserted into the uterine cavity during menstrual bleeding, within seven days of the onset of menstruation. Mirena can be immediately replaced by a new system at any time in the cycle. Mirena can also be inserted in connection with abortion. Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than six weeks after delivery. If involution is delayed, the recommendation is to wait until 12 weeks postpartum. In case of a difficult insertion or exceptional pain or bleeding during or after insertion, a gynecological examination and an ultrasound examination should be performed immediately to exclude perforation of the uterine wall. A p Baca dokumen lengkap