Kyleena 19.5 mg intrauterine delivery system

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levonorgestrel

Διαθέσιμο από:

PCO Manufacturing Ltd.

Φαρμακολογική κατηγορία (ATC):

G02BA; G02BA03

INN (Διεθνής Όνομα):

Levonorgestrel

Δοσολογία:

19.5 milligram(s)

Φαρμακοτεχνική μορφή:

Intrauterine delivery system

Θεραπευτική περιοχή:

Intrauterine contraceptives; plastic IUD with progestogen

Ημερομηνία της άδειας:

2021-06-25

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
KYLEENA
® 19.5 MG INTRAUTERINE DELIVERY SYSTEM
levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or nurse.
−
This medicine has been prescribed for you only. Do not pass it on to
others.
−
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kyleena is and what it is used for
2.
What you need to know before you use Kyleena
3.
How to use Kyleena
4.
Possible side effects
5.
How to store Kyleena
6.
Contents of the pack and other information
1.
WHAT KYLEENA IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KYLEENA
NOTES
Before you can begin using Kyleena, your healthcare professional will
ask you some
questions about your personal health history.
In this leaflet, several situations are described where Kyleena should
be removed, or where
the
reliability of Kyleena may be decreased. In such situations you should
either not have
intercourse
or you should use a condom or another barrier method.
Kyleena, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or
any other sexually transmitted disease.
Kyleena is not suitable for use as an emergency contraceptive
(postcoital contraceptive).
DO NOT USE KYLEENA IF YOU:
•
are pregnant (see section “Preg

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
29 August 2023
CRN00DRN5
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kyleena 19.5 mg intrauterine delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The intrauterine delivery system contains 19.5 mg levonorgestrel.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intrauterine delivery system (IUS).
_Product imported from Spain and France:_
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. The blue 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 inserter
consists of a handle and slider that are integrated with flange, lock,
pre-bent insertion tube and plunger. The removal threads
are located within the insertion tube and handle.
Dimensions of Kyleena: 28 x 30 x 1.55 mm
4 CLINICAL PARTICULARS
As per PA1410/081/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/081/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polydimethylsiloxane elastomer
Silica, colloidal anhydrous
Polyethylene
Barium sulfate
Polypropylene
Copper phthalocyanine
Silver
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister package and outer package of the product on
the market in the country of origin.
Health Products Regulatory Authority
29 August 2023
CRN00DRN5
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
The product is individually packed into a thermoformed blister package
(PETG) with a peelable lid (PE).
Pack size: 1x1.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
The product