情報リーフレット
MIRENA
®
CMI
1
MIRENA
®
(MI·RAY·NA)
_ _
_intrauterine levonorgestrel 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.
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 oestrogen
replacement therapy by slowly
releasing the progestogen
hormone levonorgestrel, within
the womb. Levonorgestrel
suppresses the response of the
完全なドキュメントを読む
製品の特徴
130313 MIRENA PI
1
PRODUCT INFORMATION
MIRENA
®
NAME OF THE MEDICINE
MIRENA 20 microgram per 24 hours intrauterine
delivery system contains 52 mg
levonorgestrel, a progestogen, as the active
ingredient. MIRENA is also an intrauterine
contraceptive device. The levonorgestrel initial release rate
is 20 microgram per 24
hours.
Levonorgestrel is a white
or almost white, odourless or almost odourless, crystalline
powder. It is insoluble in water or hexane, slightly soluble
in ethanol or acetone, and
sparingly soluble in methylene chloride. The
chemical name for levonorgestrel is 13
β-
ethyl-
17β-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one. The CAS registry number
for levonorgestrel is 797-63-7.
H
OH
C
CH
O
H
H
H
Chemical Formula: C21H28O2
Molecular Weight: 312.45
Melting Point: 232-239oC
DESCRIPTION
MIRENA is an intrauterine delivery system (IUS) based on
a T-shaped polyethylene
frame, with a cylinder containing a mixture
of dimethylsiloxane/methylvinylsiloxane
(cross-linked) elastomer and levonorgestrel around
its vertical arm. The cylinder is
covered by a dimethylsiloxane/methylvinylsiloxane
(cross-linked) elastomer membrane,
which regulates the release of levonorgestrel.
It contains a total of 52 mg
levonorgestrel. The levonorgestrel 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.
130313 MIRENA PI
2
Excipients
Dimethylsiloxane/methylvinylsiloxane
(cross-linked) elastomer,
完全なドキュメントを読む