Implanon NXT, 68 mg implant for subdermal use

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Etonogestrel

Inapatikana kutoka:

Lexon (UK) Ltd

ATC kanuni:

G03AC; G03AC08

INN (Jina la Kimataifa):

Etonogestrel

Kipimo:

68 milligram(s)

Dawa fomu:

Implant

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Progestogens; etonogestrel

Idhini hali ya:

Authorised

Idhini ya tarehe:

2017-03-01

Taarifa za kipeperushi

Local anaesthetic should be used before inserting or removing the
implant.
The risk of complications is small if the provided instructions are
followed.
Product procured from within the EU, repackaged and distributed by the
Parallel Product Authorisation Holder: Lexon (UK) Limited, Unit 18,
Oxleasow
Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK.
THE MANUFACTURER IS:
Organon N.V, PO Box 20, 5340 BH OSS, The Netherlands.
Implanon NXT is a registered trademark of Merck Sharp & DOHME B.V.
Revision date: 04/11/2019
PPA1097/005/001
BLIND OR PARTIALLY SIGHTED?
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PHONE LEXON (UK) LIMITED,
TEL: [phone] FOR HELP.
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA
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,
UK: 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.
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 slightly bent at the elbow and turned outwards.
•
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 anesthetized.
•
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.
POM
•
The implant should only be remove

Tabia za bidhaa

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 µg/day in week 5-6
and has decreased 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. 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.
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