Jadelle

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levonorgestrel 75mg (Micronised)

Available from:

Bayer New Zealand Limited

INN (International Name):

Levonorgestrel 75 mg (Micronised)

Dosage:

150 mg

Pharmaceutical form:

Subcutaneous implant

Composition:

Active: Levonorgestrel 75mg (Micronised) Excipient: Dow Corning QCF-7-4910 dimethylsiloxane/methylvinylsiloxane external tubing (373-TW) Polysiloxane Adhesive type A

Units in package:

Blister pack, 75mg rods, 2 implants

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Long-term contraception

Product summary:

Package - Contents - Shelf Life: Blister pack, 75mg rods - 2 implants - 60 months from date of manufacture stored at or below 30°C. Unopened

Authorization date:

2003-05-21

Patient Information leaflet

JADELLE CMI Vx1.1
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
JADELLE
®
_levonorgestrel-releasing implant 75 mg x 2 _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Jadelle.
This leaflet answers some common questions about Jadelle. 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 Jadelle
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 JADELLE IS USED FOR
Jadelle is a contraceptive implant, used to prevent pregnancy.
Contraceptive implants such
as Jadelle are for long term (up to five years) use.
The implants contain a synthetic hormone, levonorgestrel, which is
also one of the active
ingredients used in many oral contraceptives. Immediately after the
insertion of Jadelle
implants, low doses of the hormone start to be released continuously
into your body. Jadelle
prevents pregnancy through a combination of mechanisms. The most
important of these are
inhibition of the egg release by stopping it maturing and changing the
cervical mucus
consistency, making it more difficult for sperm to reach the egg.
Other mechanisms may also
be involved. When Jadelle implants are removed, your fertility will
resume.
Jadelle is inserted just beneath the skin on the inside of your upper
arm and is performed by
your doctor.
Although the implant may be removed at any time, it must be removed no
later than five
years after insertion.
If you weigh over 60 kg, your doctor may recommend that you have the
implant removed or
have a new implant inserted after the 4
th
year.
Your doctor may have prescribed Jadelle for another reason.
Ask your doctor if you have any questions about why Jadelle has been
prescribed for you.
BEFORE YOU USE JADELLE
_ _
_WHEN YOU MUST NOT USE IT _
JADELLE CMI Vx1.1
2
DO NOT USE JADELLE

Summary of Product characteristics

JADELLE DS Vx1.1; CCDS 6
Page 1 of 12
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
JADELLE® levonorgestrel 2 x 75 mg subcutaneous implants
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JADELLE
consists
of
two
implants
to
be
inserted
subdermally.
Each
implant
contains
75
mg
levonorgestrel.
The release rate of levonorgestrel is about 100 microgram/day at one
month after insertion, declining
to about 40 microgram/day within one year, to about 30 microgram/day
within three years and to
about 25 microgram/day within five years.
For full list of excipients, see List of excipients.
3
PHARMACEUTICAL FORM
Subcutaneous implant.
The implants are flexible, sealed, white to off-white rods, about 43
mm in length and 2.5 mm in
diameter
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Contraception.
4.2
Dose and method of administration
_For subcutaneous use. _
JADELLE is a contraceptive method for long-term (up to five years) use
(see Special warnings and
precautions for use).
_Insertion and Removal/Replacement _
The patient must be informed that JADELLE implants may be removed at
her request at any time.
Before insertion, the woman must be informed of the efficacy, risks,
side effects and bleeding pattern
changes to be expected with JADELLE. This discussion should include
the information that a small
proportion of women (17/1100 or 1.5%) experienced adverse effects from
the removal of JADELLE
including multiple or long incisions, pain, difficult removals and/or
additional visits for the removal.
Training is required for the insertion and removal procedures, which
should preferably be done by a
healthcare professional and the given instructions must be followed
closely. The implants are inserted
with the disposable, sterile Trocar just beneath the skin.
Important: the disposable JADELLE Trocar is for single use only. After
insertion, the Trocar must be
disposed of in an appropriate sharps container. Strict asepsis must be
observed here. The implants
are inserted in the inner aspect of the upper left arm in right-handed
women and in th