Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEVONORGESTREL
BAYER INDONESIA - Indonesia
LEVONORGESTREL
52 MG
ALAT KONTRASEPSI
DUS @ 1 IUS
BAYER SCHERING PHARMA OY - Finland
2018-04-23
MIRENA/Levonorgestrel/Intrauterine system-IUS/BEC 17811 CCDS 23 1 MIRENA ® INTRAUTERINE DELIVERY SYSTEM (IUS) Important information, please read carefully! COMPOSITION Levonorgestrel 52 mg. The initial release rate is 20 micrograms /24 hours PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Levonorgestrel is a progestin with anti-estrogenic activity used in gynecology in various ways: as the progestin component in hormone therapy and oral contraceptives and alone in the so-called ‘minipills’ and in subdermal implants. Mirena releases levonorgestrel directly into the uterus. This allows a very small daily dose, as the hormone is released directly into the target organ. The plasma concentrations of levonorgestrel are lower than with any other contraceptive method. Mirena has mainly local progestogenic effects in the uterine cavity. The high levonorgestrel concentration in the endometrium down-regulates endometrial estrogen and progesterone receptors, making the endometrium insensitive to the circulating estradiol and a strong antiproliferative effect is seen. Morphological changes of the endometrium and a weak local foreign body reaction are observed during use of Mirena. Thickening of the cervical mucus prevents passage of the sperm through the cervical canal. The local milieu of the uterus and of the ovarian tubes inhibits sperm mobility and function, preventing fertilization. Ovulation is inhibited in some women. The contraceptive efficacy of Mirena has been studied in 5 major clinical studies with 3330 women using Mirena. The failure rate (Pearl Index) was approximately 0.2 % at 1 year and the cumulative failure rate was approximately 0.7 % at 5 years. The failure rate also includes pregnancies due to undetected expulsions and perforations. Similar contraceptive efficacy has been observed in a large post-marketing study with more than 17000 women using Mirena. In a large prospective comparative non-interventional cohort study with an observation period of 1 year including more than 43.000 Mirena users, Baca dokumen lengkapnya