Jaydess
Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Bijsluiter
(PIL)
14-04-2021
Productkenmerken
(SPC)
14-04-2021
Werkstoffen:
Levonorgestrel 13.5mg
Beschikbaar vanaf:
Bayer New Zealand Limited
INN (Algemene Internationale Benaming):
Levonorgestrel 13.5 mg
Dosering:
13.5 mg
farmaceutische vorm:
Intrauterine contraceptive device
Samenstelling:
Active: Levonorgestrel 13.5mg Excipient: Dimethylsiloxane/methylvinylsiloxane cross linked elastomer Dimethylsiloxane/methylvinylsiloxane cross linked elastomer T frame
Prescription-type:
Prescription
Geproduceerd door:
Bayer AG
therapeutische indicaties:
Contraception for up to 3 years.
Product samenvatting:
Package - Contents - Shelf Life: Sachet, laminate, PETG film sealed with PE non-woven white adhesive film - 1 dose units - 36 months from date of manufacture stored at or below 30°C
Autorisatie datum:
2013-10-21
Bijsluiter
JAYDESS
®
CMI Vx3.0
1
JAYDESS
®
(JAY·DESS)
_ _
_levonorgestrel intrauterine delivery system _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Jaydess. 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
Jaydess 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 JAYDESS IS
USED FOR
Jaydess consists of a small T-
shaped frame made from a
plastic called polyethylene. This
carries 13.5 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, brown
threads, made of iron oxide and
polyethylene, attached to the
bottom of the white frame.
These allow easy removal and
allow you or your doctor to
check that the system is in
place.
Jaydess is used for the
prevention of pregnancy. It is
placed inside the womb where it
slowly releases the hormone
over a period of three years or
until it is removed.
The hormone in Jaydess
prevents pregnancy by:
•
controlling the monthly
development of the womb
lining so that it is not thick
enough for you to become
pregnant
•
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
Jaydess is an intrauterine
system (IUS)
•
affecting the movement of
sperm inside the womb,
preventing fertilisation.
JAYDESS IS NOT AN EMERGENCY
CONTRACEPTIVE.
ASK YOUR DOCTOR IF
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Productkenmerken
JAYDESS Data Sheet Vx3.0, CCDS 12
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
JAYDESS
®
13.5 mg intrauterine contraceptive device
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
JAYDESS is an intrauterine system (IUS) containing 13.5 mg
levonorgestrel. For details of
release rates, see Section 5.2.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
JAYDESS consists of a whitish or pale yellow 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. Brown 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 IUS and inserter are essentially free of visible impurities.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception for up to 3 years.
4.2
DOSE AND METHOD OF ADMINISTRATION
JAYDESS is inserted into the uterine cavity and is effective for up to
three years.
The _in vivo_ release rate is approximately 14 µg/24 hours after 24
days and is reduced to
approximately 10 µg/24 hours after 60 days. It then declines
progressively to 6 µg/24 hours after
one year and 5 µg/24 hours after three years. The average
levonorgestrel _in vivo_ release rate is
approximately 8 µg/24 hours over the first year of use and 6 µg/24
hours over the period of
three years.
JAYDESS, when inserted according to the insertion instructions, has a
failure rate of
approximately 0.4% at 1 year and a cumulative failure rate of
approximately 0.9% at 3 years.
The failure rate also includes pregnancies due to undetected
expulsions and uterine
perforations.
Care must therefore be given to undertake adequate training in the
correct insertion technique
and ensure the availability of appropriate instruments for the
insertion of JAYDESS.
4.2.1
MEDICAL EXAMINATION/CONSULTATION
Before insertion, the woman must be
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