KYLEENA levonorgestrel 19.5 mg intrauterine drug delivery system sachet

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

levonorgestrel, Quantity: 19.5 mg

から入手可能:

Bayer Australia Ltd

INN（国際名）:

Levonorgestrel

医薬品形態:

Drug delivery system, intrauterine

構図:

Excipient Ingredients: dimethylsiloxane/methylvinylsiloxane cross linked elastomer

投与経路:

Intrauterine

パッケージ内のユニット:

1 x intrauterine drug delivery system

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Contraception for up to 5 years

製品概要:

Visual Identification: Intrauterine DDS system consisting of a whitish or pale yellow drug reservoir mounted on the vertical stem of a T-body. A silver ring is attached to the stem. The T-body has a loop at one end & two blue removal threads are attached to the loop.; 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

認証ステータス:

Licence status A

承認日:

2017-01-18

情報リーフレット

KYLEENA
®
CMI Vx2.0
1
KYLEENA
®
(KAI·LEE·NA)
_ _
_levonorgestrel intrauterine delivery system _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Kyleena. 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
Kyleena 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 AND THE CARD
DESCRIBING THE DATE OF
INSERTION, BATCH NUMBER, AND
LATEST DATE OF REMOVAL IN A SAFE
PLACE.
You may need to read it again.
WHAT KYLEENA IS
USED FOR
Kyleena consists of a small T-
shaped frame made from a
plastic called polyethylene. This
carries 19.5 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 uterus
(womb).
There are two fine threads,
made of blue pigment 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.
Kyleena is used for the
prevention of pregnancy. It is
placed inside the womb where it
slowly releases the hormone
over a period of five years or
until it is removed.
The hormone in Kyleena
prevents pregnancy by:
•
controlling the monthly
development of the womb
lining so that it is not thick
enough to support a
pregnancy
•
making the normal mucus in
the cervical canal (opening to
the womb) thicker, so that the
sperm cannot get through to
fertilise the egg
•
there are also local effects on
the lining of the womb
caused by the presence of the
T-shaped frame - since
Kyleena is an intrauterine
system (IUS)
•
affecting the movement of
sperm inside the wom

製品の特徴

KYLEENA PI Vx2.0, CCDS 6
1
AUSTRALIAN PRODUCT INFORMATION
KYLEENA
®
(LEVONORGESTREL) INTRAUTERINE DRUG DELIVERY SYSTEM
1
NAME OF THE MEDICINE
Levonorgestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kyleena is an intrauterine delivery system (IUS) that contains 19.5 mg
levonorgestrel as
the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Intrauterine drug delivery system
Kyleena consists of a whitish or pale yellow drug core covered with a
semi-opaque
membrane, which is mounted on the vertical stem of a T-body. In
addition, the vertical
stem contains a silver ring located close to the horizontal arms. The
white T-body has a
loop at one end of the vertical stem and two horizontal arms at the
other end. Blue
coloured 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 inserter
consists of a handle and slider
that are integrated with flange, lock, pre-bent insertion tube and
plunger. The removal
threads are located within the insertion tube and handle.
KYLEENA PI Vx2.0, CCDS 6
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception for up to 5 years.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Kyleena is inserted into the uterine cavity and is effective for up to
five years.
The _in vivo_ release rate is approximately 17.5 µg/24 hours after 24
days and is reduced
to approximately 15.3 µg/24 hours after 60 days and to 9.8 µg/24
hours after one year. It
then declines progressively to 7.4 µg/24 hours after five years. The
average
levonorgestrel _in vivo_ release rate is approximately 12.6 µg/24
hours over the first year
and 9.0 µg/24 hours over the period of five years.
Care must therefore be given to adequate training in the correct
insertion technique and
the availability of appropriate instruments for the insertion of
Kyleena. For further
information regarding training providers, please contact Bayer
Australia Ltd.
METHOD OF ADMINISTRATION
_Medical Exami