Implanon NXT

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Etonogestrel 68mg;  ; Etonogestrel 68mg

Disponibil de la:

Organon (New Zealand) Limited

INN (nume internaţional):

Etonogestrel 68 mg

Dozare:

68 mg

Forma farmaceutică:

Subcutaneous implant

Compoziție:

Active: Etonogestrel 68mg   Excipient: Barium sulfate Ethylenevinylacetate copolymer As Evatane 10/40 VN4 co polymer   Active: Etonogestrel 68mg Excipient: Barium sulfate Ethylenevinylacetate copolymer   Magnesium stearate

Unități în pachet:

Blister pack, Sterile PET blister with EVA coated HDPE closure in card container, 1 implant

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Aspen Oss B.V

Indicații terapeutice:

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

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, Sterile PET blister with EVA coated HDPE closure in card container - 1 implants - 60 months from date of manufacture stored at or below 30°C. Exclusive of 3 year implant period

Data de autorizare:

2009-10-27

Prospect

IMPLANON NXT
®
_Etonogestrel _
NEW ZEALAND 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 vinylacetate 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 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 period o

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
IMPLANON
NXT
®
NAME OF THE MEDICINE
Etonogestrel subdermal implants.
Etonogestrel is a white to nearly white crystalline powder also known
as 3-ketodesogestrel or (17
α
)-
13-ethyl-17-hydroxy-11-methylene-18,19 dinorpregn-4-en-20-yn-3-one.
_Molecular formula C_
_22_
_H_
_28_
_O_
_2 _
_ _
_Molecular mass 324.44 _
_CAS No. 54048-10-1 _
DESCRIPTION
Implanon
NXT
is a subdermal contraceptive implant, consisting of a co-axial rod,
preloaded in an
applicator.
The rod consists of a core containing a mixture of the drug substance,
etonogestrel, and of barium
sulfate and ethylene vinylacetate copolymer and a skin consisting of
ethylene vinylacetate copolymer.
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.
_IMPLANT _
Core:
Ethylene vinylacetate copolymer (28% vinyl acetate) 43 mg _-
_proprietary ingredient,
barium sulfate (15 mg), magnesium stearate (0.1 mg)
Skin:
Ethylene vinylacetate copolymer (15% vinyl acetate) 15 mg -
proprietary ingredient
_APPLICATOR _
The applicator is designed to be operated with one hand and to help
facilitate correct subdermal
insertion of the implant.
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.
PHARMACOTHERAPEUTIC GROUP: progestagens, ATC-classification G03AC08
CCDS-MK8415-IPTx-032016
1
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
The Implanon NXT implant is a non-biodegradable, radiopaque,
etonogestrel (ENG) containing
implant for subdermal use, preloaded in a sterile, disposable
applicator. Etonogestrel is the
biologically active metabolite of desogestrel, a progestagen widely
used in oral contraceptives (OCs).
It