Mirena 52 mg Intrauterine Delivery System

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Levonorgestrel

Sẵn có từ:

Imbat Limited

Mã ATC:

G02BA; G02BA03

INN (Tên quốc tế):

Levonorgestrel

Liều dùng:

52 milligram(s)

Dạng dược phẩm:

Intrauterine delivery system

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Intrauterine contraceptives; plastic IUD with progestogen

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2017-10-27

Tờ rơi thông tin

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRENA
® 52MG INTRAUTERINE DELIVERY SYSTEM
Levonorgestrel
Your medicine is available using the name Mirena 52mg
Intrauterine Delivery System but will be referred to as Mirena
throughout the leaflet.
Patient name:
Date of fitting:
Doctor’s Name:
Telephone No:
First check-up visit:
Next visits:
1.
2.
3.
4.
5.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
DECIDE TO HAVE MIRENA FITTED 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.

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 have Mirena fitted
3.
How and when Mirena is used
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 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.
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 can be used for contraception and reducing menstrual
blood flow until it is removed or up to a maximum of
5 years.
3.
If you are going through the MENOPAUSE, a gradual
process which usually takes place between the ages of
about 45 and 55.
Oestrogens can be taken to relieve menopausal symptoms.
However, taking oestrogens alone increases the risk of
abnormal growth or cancer of the lining of the womb
(_endometrial hyperplasia_). Using a progestogen such as
Mirena in combination with oestrogen replacement therapy
lowers this risk.
_Children and adolescents _
Mirena is not indicated for use before the first menstr

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirena 52 mg Intrauterine Delivery System
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel 52 mg
The in-vivo dissolution rate is about 20 µg/24 hours initially and is
reduced to about 11 µg/24 hours after five years.
The mean dissolution rate of levonorgestrel is about 14 µg/24 hours
over the time up to five years.
For the full list of excipients, see Section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
Intrauterine delievry 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
T-body has a loop at one end of the vertical stem
and two horizontal arms at the other end. Removal threads are attached
to the loop. 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
Polydimethylsiloxane tubing
Polyethylene
Barium sulfate
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.
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