Mirena 20 micrograms/24 hours Intrauterine delivery system

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

LEVONORGESTREL

Disponible depuis:

Bayer PLC

Code ATC:

G02BA03

DCI (Dénomination commune internationale):

LEVONORGESTREL

forme pharmaceutique:

INTRAUTERINE DELIVERY SYSTEM

Composition:

LEVONORGESTREL 52 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

OTHER GYNECOLOGICALS

Statut de autorisation:

Authorised

Date de l'autorisation:

2005-05-30

Notice patient

Patient
Information
Booklet
Patient Name:
Date of Fitting:
Doctor's Name:
Telephone No:
First check-up visit:
Next visits:
1.
2.
3.
4.
5.
20 micrograms/24 hours
intrauterine delivery system (levonorgestrel)
85213997
JT JOB NO.:
300796
ITEM NO.:
85213997
DRAWN UP/OS:
DATE:
16.3.2016
CLIENT:
Bayer Oy
FOLDING:
DIMENSIONS (MM):
72 x 145
NUMBER OF PAGES:
20
FONT / FONT SIZE / SPACING:
BayerSans 9 pt / 9,9 pt
COLORS:
2/2
Pms 321, black
PHARMACODE:
1731
300796 85213997 Potilasohje Mirena EVP GB vedos.indd 1
16.3.2016 7.10
{2)
(3}
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 .... 2
2. Before you have Mirena fitted .................... 5
3. How and when Mirena is used .................10
4. Possible side effects .....................................14
5. Further information ....................................18
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 are
taking oestrogen to treat menopausal
symptoms. Therefore, if you are using it in
this way, your doctor or nurse will remove
your

Résumé des caractéristiques du produit

1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Mirena 20 micrograms/24 hours intrauterine delivery system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Each intrauterine delivery system contains 52 mg of
levonorgestrel. The
initial release rate is 20 micrograms/24 hours.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Intrauterine delivery system (IUS)
The levonorgestrel (LNG) IUS 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 IUS is loaded in the
insertion tube at the tip of
the inserter. The IUS and inserter are essentially free of visible
impurities.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception
Idiopathic menorrhagia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SPECIAL POPULATIONS
Children and adolescents
Safety and efficacy of Mirena have been established in women of
reproductive age. There is
no relevant indication for the use of Mirena before menarche.
Geriatric patients
Mirena has not been studied in women over the age of 65 years.
Patients with hepatic impairment
Mirena has not been studied in women with acute liver disease or liver
tumors, see 4.3
Contraindications.
Patients with renal impairment
2 of 13
Mirena has not been studied in women with renal impairment.
Method of administration
Mirena is inserted into the uterine cavity and is effective for five
years.
The in vivo dissolution rate is approximately 20 micrograms/24 hours
initially and is reduced
to 10 micrograms/24 hours after five years. The mean dissolution rate
of levonorgestrel is
about 14 micrograms/24 hours over the time up to five years.
Mirena, when inserted according to the insertion instructions (see
separate document
'Insertion instructions'), has a failure rate of approximately 0.2% at
1 year and a cumulative
failure rate