Implanon NXT, 68 mg implant for subdermal use

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Etonogestrel

Disponibbli minn:

PCO Manufacturing Ltd.

Kodiċi ATC:

G03AC08

INN (Isem Internazzjonali):

Etonogestrel

Dożaġġ:

68 milligram(s)

Għamla farmaċewtika:

Implant

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

etonogestrel

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2012-05-04

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IMPLANON NXT
® 68 MG IMPLANT
FOR SUBDERMAL USE
etonogestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
Your doctor will give you a Patient Alert Card that contains
important information you need to be aware of. Store the card in a
safe place, and show it to your healthcare professional at any
visits related to the use of your implant
WHAT IS IN THIS LEAFLET:
1.
What Implanon NXT is and what it is used for
2.
What you need to know before you use Implanon NXT
3.
How to use Implanon NXT
4.
Possible side effects
5.
How to store Implanon NXT
6.
Contents of the pack and other information
7.
Information for the healthcare professional
1.
WHAT IMPLANON NXT IS AND WHAT IT IS USED FOR
Implanon NXT is a contraceptive implant preloaded in a
disposable applicator. Safety and efficacy have been
established in women between 18 and 40 years of age. The
implant is a small, soft, flexible, plastic rod, 4 cm in length and
2 mm in diameter, which contains 68 milligrams of the active
substance, etonogestrel. The applicator allows the healthcare
professional to insert the implant just under the skin of your
upper arm. Etonogestrel is a synthetic female hormone
resembling progesterone. A small amount of etonogestrel is
continuously released into the bloodstream. The implant itself is
made of ethylene vinyl acetate copolymer, a plastic that will not
dissolve in the body. It also contains a small amount of barium
sulphate which renders it visible under X-ray.
IMPLANON NXT IS USED TO PREVENT PREGNANCY
HOW DOES IMPLANON NXT WORK
The implant is inserted just below the skin. The active
compound, etonogestrel, work

Karatteristiċi tal-prodott

Health Products Regulatory Authority
06 November 2023
CRN00DWX7
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 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 Portugal and France_
Non-biodegradable, white to off-white, flexible rod.
4 CLINICAL PARTICULARS
As per PA23198/017/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/017/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Implant
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Core: Ethylene vinylacetate copolymer (28% vinyl acetate, 43 mg)
barium sulfate (15 mg), magnesium stearate
Skin: Ethylene vinylacetate copolymer (14% vinyl acetate, 15 mg)
_Product imported from France_
_ _
Ethylene vinylacetate copolymer, barium sulfate, magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister pack and outer packaging of the product as
marketed in the country of origin.
Implanon NXT should not be inserted after the expiry date as indicated
on the primary package.
Health Products Regulatory Authority
06 November 2023
CRN00DWX7
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 (4 cm in le