JANESS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVONORGESTREL

Available from:

BAYER ISRAEL LTD

ATC code:

G03AC03

Pharmaceutical form:

INTRAUTERINE DELIVERY SYSTEM

Composition:

LEVONORGESTREL 13.5 MG

Administration route:

INTRAUTERINE

Prescription type:

Required

Manufactured by:

BAYER OY, FINLAND

Therapeutic area:

LEVONORGESTREL

Therapeutic indications:

Contraception for up to 3 years.

Authorization date:

2020-02-29

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: J601,J605
material-no.: 89482577
PZ: 7621B-V0
code-no.:
name: LF-BRO JANESS 13.5MG IUS BLI 1X1 PAT IL
country: IL/ARA-ENG-HEB
colors: BLACK
version: 07.11.2022/01
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
JANESS
®
INTRAUTERINE DELIVERY SYSTEM
The active ingredient is levonorgestrel 13.5 mg
Inactive ingredients and allergens: see section 6 “Further
Information”.
READ THIS 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.
The medicine is not intended for use before the first menstrual
bleeding (first menses).
1) WHAT IS THE MEDICINE INTENDED FOR?
WHAT IS JANESS?
Janess is a T-shaped intrauterine delivery system which slowly
releases a small amount of the hormone levonorgestrel after
its installation inside the womb.
The system is intended for contraception for a period of up to
3 years.
Janess works by reducing the monthly growth of the lining
of the womb and thickening of the cervical mucosal layer.
These actions prevent the sperm and egg from coming into
contact and so prevent fertilization of an egg by sperm.
THERAPEUTIC GROUP: Janess belongs to a group of
medicines
that contain 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 any of the other ingredients contained
in the medicine. For a list of the inactive ingredients, see
section 6 “Further Information”.
•
you are pregnant (see “Pregnancy, breastfeeding and
fertility” in section 2).
•
you have, or have had several time

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Janess 13.5 mg intrauterine delivery system.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The intrauterine delivery system contains 13.5 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).
The product consists of a whitish or pale yellow drug core covered
with a semi-
opaque membrane, which is mounted on the vertical stem of a T-body. In
addition,
the vertical stem contains a silver ring located close to the
horizontal arms. The white
T-body has a loop at one end of the vertical stem and two horizontal
arms at the
other end. Brown coloured removal
threads are attached to the loop. The vertical
stem of the IUS is loaded in the insertion tube at the tip of the
inserter. The IUS and
inserter are essentially free of visible impurities.
Dimensions of Janess: 28 x 30 x 1.55 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception for up to 3 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Janess is inserted into the uterine cavity and is effective for up to
three years.
_Insertion and removal/ replacement _
It is recommended that Janess should only be inserted by physicians/
healthcare
providers who are experienced in IUS insertions and/or have undergone
training on
the Janess insertion procedure.
Janess is to be inserted into the uterine cavity within seven days of
the onset of
menstruation. Janess can be replaced by a new system at any time in
the cycle.
Janess can also be inserted immediately after first trimester
abortion.
Postpartum insertions should be postponed until the uterus is fully
involuted, however
not earlier than six weeks after delivery. If involution is
substantially delayed,
consider waiting until 12 weeks postpartum.
Page 2 of 20
In case of a difficult insertion and/or exceptional pain or bleeding
during or after
insertion, appropriate steps should be taken immediately to exclude
pe