Mirena

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Levonorgestrel 52mg

Disponibil de la:

Bayer New Zealand Limited

INN (nume internaţional):

Levonorgestrel 52 mg

Dozare:

52 mg

Forma farmaceutică:

Intrauterine contraceptive device

Compoziție:

Active: Levonorgestrel 52mg

Unități în pachet:

Individual wrap, 1 dose unit

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Bayer AG

Indicații terapeutice:

Contraception

Rezumat produs:

Package - Contents - Shelf Life: Individual wrap, - 1 dose units - 36 months from date of manufacture stored at or below 30°C

Data de autorizare:

1997-03-11

Prospect

MIRENA
®
CMI Vx4.0
1
MIRENA
®
(MI·RAY·NA)
_ _
_levonorgestrel intrauterine delivery system _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Mirena. It does not contain all
the available information. It
does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Mirena against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MIRENA IS
USED FOR
Mirena consists of a small T-
shaped frame made from a
plastic called polyethylene. This
carries 52 mg levonorgestrel, a
hormone used in many
contraceptive pills. The
hormone is contained within a
substance called
dimethylsiloxane/methylvinylsil
oxane cross linked elastomer
and is surrounded by a
membrane (skin) also made of
the same elastomer.
This structure provides a system
for releasing the hormone
gradually into the womb
(uterus).
There are two fine threads,
made of iron oxide and
polyethylene, attached to the
bottom of the frame. These
allow easy removal and allow
you or your doctor to check that
the system is in place.
Mirena may be used as a long
term and reversible method of
contraception, for the treatment
of excessive menstrual bleeding
(menorrhagia) or for protection
from endometrial hyperplasia
(excessive growth of the lining
of the womb) during hormone
replacement therapy. It is placed
inside the womb where it slowly
releases the hormone (at an
initial rate of 20 micrograms per
24 hours) over a period of five
years or until it is removed.
Mirena works in the treatment
of excessive monthly bleeding
and as protection in estrogen
replacement therapy by slowly
releasing the progestogen
hormone levonorgestrel, within
the womb. Levonorgestrel
suppresses the response of the
cells in the lining of the womb
to estrogen making the lining of
the womb insensitive to
circulating estradiol. Th

Caracteristicilor produsului

MIRENA Data Sheet Vx4.0, CCDS 25
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MIRENA 52 mg intrauterine contraceptive device (release rate: 20
microgram/24 hours)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIRENA is an intrauterine system (IUS) containing 52 mg
levonorgestrel. For details of release
rates, see Section 5.2.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
MIRENA 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 vertical stem
of the levonorgestrel
intrauterine system is loaded in the insertion tube at the tip of the
inserter. Inserter components
are an insertion tube, plunger, flange, body and slider. The white
T-body has a loop at one end
of the vertical stem and two horizontal arms at the other end. Brown
coloured removal threads
are attached to the loop. The T-body of MIRENA contains barium
sulfate, which makes it visible
in X-ray examination. The IUS and inserter are essentially free from
visible impurities.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception
Treatment of idiopathic menorrhagia provided there is no underlying
pathology.
Prevention of endometrial hyperplasia during estrogen replacement
therapy
MIRENA Data Sheet Vx4.0, CCDS 25
2
4.2
DOSE AND METHOD OF ADMINISTRATION
MIRENA is inserted into the uterine cavity. One administration is
effective for five years.
The _in vivo_ dissolution rate is approximately 20 microgram/24 hours
initially and is reduced to
approximately 18 microgram/24 hours after 1 year and to 10
microgram/24 hours after five
years. The mean dissolution rate of levonorgestrel is about 15
microgram /24 hours over the
time up to five years.
In women under hormone replacement therapy, MIRENA can be used in
combination with oral
or transdermal estrogen preparations without progestogens.
MIRENA,
when
inserted
according
to
the
insertion
instructions,
has
a
failure
rate
of
approximately 0.2% at 1 year and a cumulative failure rate of
approximately 0.7 % at