IMPLANON NXT etonogestrel 68mg subcutaneous implant

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

etonogestrel, Quantity: 68 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: magnesium stearate; barium sulfate; vinyl acetate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer

Administration route:

Subcutaneous

Units in package:

1 implant plus application device

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Contraception (removed and replaced every three years to ensure continued contraceptive efficacy)

Product summary:

Visual Identification: White to off white, coaxial rod, 4cm in length and 2mm in diameter. The implant is located inside the preloaded, sterile applicator and is packed in a polyethylene tray with a foil lid.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-05-11

Patient Information leaflet

IMPLANON NXT
®
_Etonogestrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet provides information that
may help you in your decision to
start using Implanon NXT. It will
also advise you how to use Implanon
NXT properly and safely. It answers
some common questions about
Implanon NXT. 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 Implanon NXT
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU DECIDE TO HAVE
IMPLANON NXT INSERTED.
KEEP THIS LEAFLET.
You may need to read it again. It is
important to stay alert on matters that
do not affect you now, but may affect
you in the future.
WHAT IMPLANON NXT IS
USED FOR?
_WHAT DOES IT CONTAIN?_
Implanon NXT is a contraceptive
implant preloaded in a disposable
applicator. The implant contains 68
mg of the active substance
etonogestrel. Etonogestrel is a
synthetic female hormone resembling
progesterone. A small amount of the
hormone etonogestrel is continuously
released into the bloodstream for
three years. The rod itself is made of
ethylene vinyl acetate copolymer, a
plastic that will not dissolve in the
body. It also contains small amounts
of barium sulfate (which renders it
visible under X-ray) and magnesium
stearate.
ALTHOUGH THE IMPLANT MAY BE
REMOVED AT ANY TIME, IT MUST BE
REMOVED NO LATER THAN THREE YEARS
AFTER INSERTION.
_HOW DOES IMPLANON NXT_
_WORK?_
Implanon NXT is used to prevent
pregnancy.
Implanon NXT is placed directly
under the skin at the inner side of the
non-dominant upper arm.
Implanon NXT prevents pregnancy
in two ways:
•
It prevents the release of an egg
cell from the ovaries (ovulation)
•
It causes changes to cervical
mucus that makes it difficult for
sperm to enter the womb.
As a result, Implanon NXT protects
you against pregnancy for a perio

Summary of Product characteristics

Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
IMPLANON NXT
®
(ETONOGESTREL)
SUBDERMAL IMPLANT
1
NAME OF THE MEDICINE
Etonogestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each radiopaque implant contains 68 mg etonogestrel; the release rate
is 60-70 μg/day during
week 5-6, and decreases to approximately 35-45 μg/day at the end of
the first year, to
approximately 30-40 μg/day at the end of the second year, and to
approximately 25-30 μg/day
at the end of the third year.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Implanon NXT (etonogestrel) is a subdermal contraceptive implant,
consisting of a co-axial
rod, preloaded in an applicator.
The radiopaque implant is a non-biodegradable, white to off-white,
flexible rod with a length of
4.0 cm and a diameter of 2.0 mm and is located inside the preloaded,
sterile, ready-for-use,
disposable applicator.
The rod consists of a core containing a mixture of the drug substance,
etonogestrel, and of
barium sulfate and ethylene vinyl acetate copolymer and a skin
consisting of ethylene vinyl
acetate copolymer.
_APPLICATOR _
The applicator is designed to be operated with one hand and to help
facilitate correct
subdermal insertion of the implant.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception (removed and replaced every three years to ensure
continued contraceptive
efficacy).
4.2
DOSE AND METHOD OF ADMINISTRATION
PREGNANCY SHOULD BE EXCLUDED BEFORE INSERTION OF IMPLANON NXT
HEALTHCARE PROFESSIONALS (HCPS) ARE STRONGLY RECOMMENDED TO
PARTICIPATE IN A TRAINING
SESSION TO BECOME FAMILIAR WITH THE USE OF THE IMPLANON NXT APPLICATOR
AND THE
TECHNIQUES
FOR
INSERTION
AND
REMOVAL
OF
THE
IMPLANON
NXT
IMPLANT
AND
WHERE
APPROPRIATE, REQUEST SUPERVISION PRIOR TO INSERTING OR REMOVING THE
IMPLANT.
Before inserting the implant, carefully read and follow the
instructions for insertion and removal
of the implant in the sections HOW TO INSERT IMPLANON NXT and HOW TO
REMOVE IMPLANON
NXT.
Page 2 of 25
Videos
demonstrating
insertion
an