KYLEENA

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

LEVONORGESTREL

Boleh didapati daripada:

BAYER ISRAEL LTD

Kod ATC:

G03AC03

Borang farmaseutikal:

INTRAUTERINE DELIVERY SYSTEM

Komposisi:

LEVONORGESTREL 19.5 MG

Laluan pentadbiran:

INTRAUTERINE

Jenis preskripsi:

Required

Dikeluarkan oleh:

BAYER OY, FINLAND

Kawasan terapeutik:

LEVONORGESTREL

Tanda-tanda terapeutik:

Contraception for up to 5 years

Tarikh kebenaran:

2023-11-30

Risalah maklumat

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: J601,J605
material-no.: 89641675
PZ: 7621B-V0
code-no.:
name: LF-BRO KYLEENA 19.5MG IUS BLI 1X1 PAT IL
country: IL/ARA-ENG-HEB/BAG
colors: BLACK
version: 01.03.2023/01
Restricted Document
dimension: 72 X 145 MM
page: 2 /
2
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
KYLEENA®
INTRAUTERINE DELIVERY SYSTEM
The
intrauterine
delivery
system
contains:
19.5
mg
levonorgestrel.
Inactive ingredients and allergens in this medicine - see
section 6 “Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass
it on to others. It may harm them even if it seems to you
that their medical condition is similar.
Kyleena is not indicated for use before the first menstrual
bleeding
(menarche)
and
is
not
indicated
for
use
in
postmenopausal women.
1. WHAT IS THE MEDICINE INTENDED FOR?
WHAT IS KYLEENA?
Kyleena
is
used
for
the
prevention
of
pregnancy
(contraception) for up to five years.
Kyleena is a T-shaped intrauterine delivery system (IUS)
which after placement inside the womb slowly releases a
small amount of the hormone levonorgestrel.
Kyleena 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.
THERAPEUTIC
GROUP:
Kyleena
belongs
to
a
group
of
medicines containing the female hormone progestogen.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient
levonorgestrel
or
to
any
of
the
other
ingredients
contained in the medicine. For the list of inactive
ingredients, see section 6 “Further Information”.
•
you are pregnant (see in sec

Ciri produk

RESTRICTED
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kyleena
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The intrauterine delivery system contains 19.5 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).
Dimensions of Kyleena: 28 x 30 x 1.55 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception for up to 5 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Kyleena is inserted into the uterine cavity and is effective for up to
5 years.
_Insertion and removal/replacement _
_ _
It is recommended that Kyleena should only be inserted by
physicians/healthcare professionals who are
experienced in IUS insertions and/ or have undergone training on the
Kyleena insertion procedure.
Kyleena is to be inserted into the uterine cavity within 7 days of the
onset of menstruation. Kyleena can be
replaced by a new system at any time in the cycle. Kyleena can also be
inserted immediately after first
trimester abortion.
Postpartum insertions should be postponed until the uterus is fully
involuted, however not earlier than
6 weeks after delivery. If involution is substantially delayed,
consider waiting until 12 weeks postpartum.
In case of a difficult insertion and/ or exceptional pain or bleeding
during or after insertion, the possibility of
perforation should be considered and appropriate steps should be
taken, such as physical examination and
ultrasound. Physical examination may not be sufficient to exclude
partial perforation.
Kyleena can be distinguished from other IUSs by the combination of the
visibility of the silver ring on
RESTRICTED
ultrasound and the blue colour of the removal threads. The T-frame of
Kyleena contains barium sulfate
which makes it visible in X-ray examination.
Kyleena is removed by gently pulling on the threads with a forceps. If
the threads are not visible and the
system is found to be in the uterine cavity on ultrasound examination,
it m