MIRENA

Šalis: Indonezija

kalba: indoneziečių

Šaltinis: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Veiklioji medžiaga:

LEVONORGESTREL

Prieinama:

BAYER INDONESIA - Indonesia

INN (Tarptautinis Pavadinimas):

LEVONORGESTREL

Dozė:

52 MG

Vaisto forma:

ALAT KONTRASEPSI

Vienetai pakuotėje:

DUS @ 1 IUS

Pagaminta:

BAYER SCHERING PHARMA OY - Finland

Leidimo data:

2018-04-23

Prekės savybės

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,