MIRENA levonorgestrel 52mg intrauterine drug delivery system sachet

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

levonorgestrel, Quantity: 52 mg

Tilgængelig fra:

Bayer Australia Ltd

Lægemiddelform:

Drug delivery system, intrauterine

Sammensætning:

Excipient Ingredients: dimethylsiloxane/methylvinylsiloxane cross linked elastomer

Indgivelsesvej:

Intrauterine

Enheder i pakken:

1 plus insertion device

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Contraception. Treatment of idiopathic menorrhagia. Prevention of endometrial hyperplasia during oestrogen replacement therapy.

Produkt oversigt:

Visual Identification: The intrauterine drug delivery system consists of a white or almost white hormone sleeve, mounted on a T-body and covered with opaque tubing.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2000-07-24

Indlægsseddel

MIRENA
®
CMI Vx3.0
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 oestradiol. T

Produktets egenskaber

MIRENA PI Vx3.0, CCDS 25
1
AUSTRALIAN PRODUCT INFORMATION
MIRENA
®
(LEVONORGESTREL) INTRAUTERINE DRUG DELIVERY SYSTEM
1
NAME OF THE MEDICINE
Levonorgestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIRENA 20
microgram per 24
hours
intrauterine delivery system contains 52 mg
levonorgestrel, a progestogen, as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Intrauterine drug delivery system
MIRENA intrauterine delivery system (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 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-body of MIRENA
contains barium sulfate, which makes it visible in X-ray examination.
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
MIRENA is indicated for:
•
Contraception
•
Treatment of idiopathic menorrhagia
•
Prevention of endometrial hyperplasia during estrogen replacement
therapy.
MIRENA PI Vx3.0, CCDS 25
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The _in vivo_ dissolution rate is approximately 20 microgram/24 h and
is gradually reduced
to approximately 10 microgram/24 h after five years. The mean
dissolution rate of
levonorgestrel is about 14 microgram/24 h over the time up to five
years.
Special instructions for insertion are in the package. The insertion
technique differs to
that for other intrauterine devices. Care must therefore be given to
adequate training in
the correct insertion technique and the availability of appropriate
instruments for the
insertion of MIRENA.
METHOD OF ADMINISTRATION
_Medical Examination _
Before insertion, the woman must be informed of the efficacy, risks
and side effects of
MIRENA. A physical examination including pelvic examination and
e