Implanon NXT, 68 mg implant for subdermal use

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etonogestrel

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

G03AC; G03AC08

INN (International Name):

Etonogestrel

Dosage:

68 milligram(s)

Pharmaceutical form:

Implant

Prescription type:

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

Therapeutic area:

Progestogens; etonogestrel

Authorization status:

Marketed

Authorization date:

1999-03-19

Patient Information leaflet

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 health care 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, works in two ways:

It

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2020
CRN009KVY
Page 1 of 17
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
Radiopaque, non-biodegradable, white to off-white, soft flexible rod
with a length of 4 cm and 2 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
Safety and efficacy have been established in women between 18 and 40
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 implant, which can be left in place for three years.
_Paediatric population_
The safety and efficacy of Implanon NXT in adolescents under the age
of 18 have not been established.
Method of administration
PREGNANCY SHOULD BE EXCLUDED BEFORE INSERTION OF IMPLANON NXT.
​
IT IS STRONGLY RECOMMENDED THAT IMPLANON NXT BE INSERTED AND REMOVED
ONLY BY HEALTHCARE PROFESSIONALS (HCPS) WHO
HAVE COMPLETED TRAINING FOR THE USE OF THE IMPLANON NXT APPLICATOR AND
THE TECHNIQUES FOR INSERTION AND REMOVAL OF
THE IMPLANON NXT IMPLANT, AND, WHERE APPROPRIATE, THAT SUPERVISION BE
REQUESTED 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 section 4.2
How to insert Implanon NXT and How to remove Implanon NXT.
Videos demonstrat