Mirena 20micrograms/24hours intrauterine device

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Levonorgestrel

Доступна з:

Bayer Plc

Код атс:

G03AC03

ІПН (Міжнародна Ім'я):

Levonorgestrel

Дозування:

20microgram/24hour

Фармацевтична форма:

Intrauterine device

Адміністрація маршрут:

Intrauterine

Клас:

No Controlled Drug Status

Тип рецепту:

Caution - AMP level prescribing advised

Огляд продуктів:

BNF: 07030203; GTIN: 5016703006183

інформаційний буклет

PIL v 025_0
Page 1 of 10
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
DATE OF INSERTION = X
SPOTTING = ○
BLEEDING = ●
MONTH 1
MONTH 2
MONTH 3
MONTH 4 MIRENA
®
20 MICROGRAMS/24 HOURS
INTRAUTERINE DELIVERY SYSTEM (LEVONORGESTREL)
PATIENT INFORMATION BOOKLET
Patient Name:
Date of Fitting:
Doctor’s Name:
Telephone No:
First check-up visit:
Next visits:
1.
2.
3.
4.
5.
PIL v 025_0
Page 2 of 10
ABOUT THIS BOOKLET
Please read this booklet carefully before you decide to have Mirena
fitted.
It provides you with some useful information about Mirena. The
information in this booklet
applies only to Mirena. If you have any questions or are not sure
about anything, please ask
your doctor or nurse.
IN THIS BOOKLET:
1. WHAT MIRENA IS AND WHAT IT IS USED FOR
_page number_
2. BEFORE YOU HAVE MIRENA FITTED
_page number_
3. HOW AND WHEN MIRENA IS USED
_page number_
4. POSSIBLE SIDE EFFECTS
_page number_
5. FURTHER INFORMATION
_page number_
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, if you suffer from heavy periods
(HEAVY MENSTRUAL
BLEEDING).
It can be used for contraception and heavy menstrual bleeding until it
is removed or up to a
maximum of 5 years.
3. If you are going through the menopause Mirena can be used in
conjunction with an
oestrogen as part of a HORMONE REPLACEMENT THERAPY (HRT) REGIMEN to
protect the lining of
your womb.
Not so much is known about how well Mirena protects the lining of the
womb beyond
4 years of use in women who ar

Характеристики продукта

OBJECT 1
MIRENA
Summary of Product Characteristics Updated 12-Apr-2018 | Bayer plc
1. Name of the medicinal product
Mirena
®
20 micrograms/24 hours intrauterine delivery system
2. Qualitative and quantitative composition
Levonorgestrel 52mg.
The initial release of levonorgestrel is approximately 20 micrograms
per day.
For details of release rates, see section 5.2.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Levonorgestrel-releasing intrauterine system (IUS).
The product consists of an inserter and levonorgestrel intrauterine
system, which is loaded at the tip of the
inserter. Inserter components are an insertion tube, plunger, flange,
body and slider. The system consists
of a white or almost white hormone-elastomer core, mounted on a T-body
and covered in opaque tubing,
which regulates the release of levonorgestrel. The white T-body has a
loop at one end and two 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.
4. Clinical particulars
4.1 Therapeutic indications
Contraception.
Idiopathic menorrhagia. Mirena may be particularly useful in women
with idiopathic menorrhagia
requiring (reversible) contraception.
Protection from endometrial hyperplasia during oestrogen replacement
therapy.
4.2 Posology and method of administration
_STARTING TREATMENT_
• Contraception and idiopathic menorrhagia
In women of fertile age, Mirena is inserted into the uterine cavity
within seven days of the onset of
menstruation. It can be replaced by a new system at any time of the
cycle.
Post-partum insertion: To reduce the risk of perforation, postpartum
insertions should be postponed until
the uterus is fully involuted. Do not insert earlier than six weeks
after delivery. If the patient is
experiencing significant post-partum bleeding and/or pain then
infection or other causes should be
excluded before insertion. Mirena can also be inserted immediately
after the first trimester abortion.
Mirena is