Kyleena 19.5 mg intrauterine delivery system

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levonorgestrel, micronized

Διαθέσιμο από:

Bayer Limited

Φαρμακολογική κατηγορία (ATC):

G02BA; G02BA03

INN (Διεθνής Όνομα):

Levonorgestrel, micronized

Δοσολογία:

19.5 milligram(s)

Φαρμακοτεχνική μορφή:

Intrauterine delivery system

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Intrauterine contraceptives; plastic IUD with progestogen

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2016-12-16

Φύλλο οδηγιών χρήσης

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BP22015_REC30367
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
GENERAL 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).
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BP22015_REC30367
DO NOT USE KYLEENA IF Y

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
28 April 2023
CRN00DJJ6
Page 1 of 17
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.
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. 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
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 _
It is recommended that Kyleena should only be inserted by healthcare
professionals who are experienced in IUS insertions and/
or have undergone training on the Kyleena insertion procedure.
Before insertion, the patient should have been carefully examined in
order to detect any contraindication to IUS insertion.
Exclude pregnancy before insertion. Consider the possibility of
ovulation and conception before using this product. Kyleena is
not suitable for use as a post-coital contraceptive (see section 4.3
and section 4.4 under Medical examination/consultation).
Table 1: When to insert Kyleena in women of fertile age
Starting Kyleena

Kylee