Mirena 52 mg Intrauterine Delivery System

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Levonorgestrel

זמין מ:

IMED Healthcare Ltd.

קוד ATC:

G02BA; G02BA03

INN (שם בינלאומי):

Levonorgestrel

כמות:

52 milligram(s)

טופס פרצבטיות:

Intrauterine delivery system

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Intrauterine contraceptives; plastic IUD with progestogen

מצב אישור:

Authorised

תאריך אישור:

2017-03-10

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRENA
® 52 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 Mirena is and what it is used for
2.
What you need to know before you use Mirena
3.
How to use Mirena
4.
Possible side effects
5.
How to store Mirena
6.
Contents of the pack and other information
1.
WHAT MIRENA IS AND WHAT IT IS USED FOR
Mirena is an intrauterine delivery system (IUS) placed inside the
womb (uterus) where it slowly releases the hormone
levonorgestrel. It can be used in the following three ways:
1. As an effective long-term and reversible method of
CONTRACEPTION.
It is used for prevention of pregnancy (contraception) for a
maximum of 8 years.
2. For REDUCING MENSTRUAL BLOOD FLOW, so it can be used if you
suffer from heavy periods (heavy menstrual bleeding). This is
called menorrhagia.
It is used for heavy menstrual bleeding (idiopathic menorrhagia)
for up to 5 years. If symptoms have not returned after 5 years of
use, continued use may be considered. Your Mirena should be
removed or replaced after a maximum of 8 years.
3. If you are going through the MENOPAUSE, a gradual process
which usually takes place between the ages of about 45 and 55.
It is used for protection from excessive growth of the lining of the
womb (endometrial hyperplasia) during oestrogen replacement
therapy for a maximum of 5 years.
If you like, you may have a new Mirena inserted when the old one
is removed.
Oestrogens can be taken to relieve menopausal symptoms.
However, taking oestrogens alone increases the risk of abnormal
growth or ca

מאפייני מוצר

Health Products Regulatory Authority
10 March 2023
CRN00DG2L
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirena 52 mg Intrauterine Delivery System
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Levonorgestrel 52 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intrauterine delivery system.
_Product imported from France_
The levonorgestrel intrauterine delivery system consists of a white or
almost white drug core covered with an opaque
membrane, which is mounted on the vertical stem of a T-body. The white
T-body has a loop at one end of the vertical stem
and two horizontal arms at the other end. Brown removal threads are
attached to the loop. The T-frame of Mirena contains
barium sulphate, which makes it visible in X-ray examination. The
vertical stem of the intrauterine delivery system is loaded in
the insertion tube at the tip of the inserter.
4 CLINICAL PARTICULARS
As per PA1410/008/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/008/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polydimethylsiloxane elastomer
Anhydrous colloidal silica
Polyethylene
Barium sulphate
Iron oxide
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package to protect from moisture and direct
sunlight.
Health Products Regulatory Authority
10 March 2023
CRN00DG2L
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
The product is individually packed into a thermoformed blister package
with a peelable lid.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Mirena is supplied in a sterile pack which should not be opened until
required for insertion. The exposed product should be
handled with aseptic precautions. If the seam of the sterile envelope
is