Implanon NXT, 68 mg implant for subdermal use

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etonogestrel

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

G03AC; G03AC08

INN (International Name):

Etonogestrel

Dosage:

68 milligram(s)

Pharmaceutical form:

Implant

Therapeutic area:

Progestogens; etonogestrel

Authorization date:

2017-03-01

Patient Information leaflet

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THIS MEDICINE IS AUTHORISED IN THE MEMBER STATES OF THE EUROPEAN
ECONOMIC AREA AND IN THE UNITED KINGDOM (NORTHERN IRELAND) UNDER THE
FOLLOWING NAMES:
Austria, Belgium, Germany, Greece, Ireland, Luxembourg, Malta, the
Netherlands, Slovakia, Poland, Portugal, Spain: Implanon NXT
Denmark, Estonia, Finland, France, Iceland, Italy, Norway, Romania,
Sweden,
United Kingdom (Northern Ireland): Nexplanon
THESE PICTOGRAMS ARE ONLY MEANT TO ILLUSTRATE THE INSERTION AND
REMOVAL
PROCEDURES _FOR THE WOMAN_ WHO WILL BE RECEIVING THE IMPLANT.
NOTE: THE EXACT PROCEDURES FOR THE INSERTION AND REMOVAL OF IMPLANON
NXT BY THE QUALIFIED HEALTHCARE PROFESSIONAL ARE DESCRIBED IN THE
SUMMARY OF PRODUCT CHARACTERISTICS AND IN SECTION 7 ON THE OTHER SIDE
OF
THIS USER PACKAGE LEAFLET.
6.1 HOW IS IMPLANON NXT INSERTED
•
Insertion of Implanon NXT should only be performed by a qualified
healthcare professional who is familiar with the procedure.
•
To facilitate the insertion of the implant, you should lie on your
back, with
your arm bent at the elbow and with your hand underneath your head (or
as close as possible).
•
The implant will be inserted at the inner side of your upper
non-dominant
arm (the arm that you do not write with).
•
The insertion site will be indicated on the skin, the site is
disinfected and
anesthetised.
•
The skin is stretched and the needle is inserted, DIRECTLY under the
skin.
Once the tip is inside the skin the needle is completely inserted in a
movement parallel to the skin.
• The purple slider is unlocked to retract the needle. The implant will
remain in the upper arm when the needle is withdrawn. • THE PRESENCE OF THE IMPLANT SHOULD BE VERIFIED BY FEELING IT (PALPATION) IMMEDIATELY FOLLOWING INSERTION. A CORRECTLY INSERTED IMPLANT CAN BE FELT BETWEEN THUMB AND FINGER BY BOTH THE HEALTHCARE PROFESSIONAL AND BY YOU. IT SHOULD BE REALIZED THAT PALPATION IS NOT SUITABL

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2022
CRN00CS1G
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Implanon NXT, 68 mg implant for subdermal use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Implanon NXT is a radiopaque, non-biodegradable, progestagen-only,
flexible implant preloaded in a sterile, disposable
applicator.
Each radiopaque implant contains 68 mg of etonogestrel; the release
rate is approximately 60-70 microgram/day in week 5-6
and has decreased to approximately 35-45 microgram/day at the end of
the first year, to approximately 30-40 microgram/day
at the end of the second year and to approximately 25-30 microgram/day
at the end of the third year. The applicator is
designed to be operated with one hand and to help facilitate correct
subdermal insertion of the implant.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant for subdermal use.
_Product imported from France._
Radiopaque, non-biodegradable, white to off-white, soft flexible rod
with a length of 4 cm and 2 mm in diameter.
4 CLINICAL PARTICULARS
As per PA1286/050/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/050/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Implant:
Core: Ethylene vinyl acetate copolymer (28 % vinyl acetate, 43 mg)
barium sulfate (15 mg)
magnesium stearate (0.1 mg).
Skin:
Ethylene vinyl acetate copolymer (15 % vinyl acetate, 15 mg).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
04 February 2022
CRN00CS1G
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
Store in the original blister package.
6.5 NATURE AND CONTENTS OF CONTAINER
The pack contains one implant which is preloaded in the needle of a
ready-for-use, disposable sterile applicator. The applicator
containing the implant is packe