Mirena intrauterine delivery system

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

levonorgestrel

Dostępny od:

Bayer Oy

Kod ATC:

G02BA03

INN (International Nazwa):

levonorgestrel

Dawkowanie:

52mg

Forma farmaceutyczna:

intrauterine delivery system

Sztuk w opakowaniu:

(1) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2019-12-24

Charakterystyka produktu

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