Nexplanon 68mg implant

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Etonogestrel

Dostupno od:

Organon Pharma (UK) Ltd

ATC koda:

G03AC08

INN (International ime):

Etonogestrel

Doziranje:

68mg

Farmaceutski oblik:

Prolonged-release subcutaneous implant

Administracija rute:

Subcutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 07030202; GTIN: 5012376032399

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEXPLANON
® 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.
_ _
WHAT IS IN THIS LEAFLET
1.
What Nexplanon
is and what it is used for
2.
What you need to know before you use Nexplanon
3.
How to use Nexplanon
4.
Possible side effects
5.
How to store Nexplanon
6.
Contents of the pack and other information
7.
Information for the health care professional
1.
WHAT NEXPLANON IS AND WHAT IT IS USED FOR
Nexplanon is a contraceptive implant preloaded in a disposable
applicator for women 18 to 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.
NEXPLANON IS USED TO PREVENT PREGNANCY.
HOW DOES NEXPLANON WORK
The implant is inserted just below the skin. The active compound,
etonogestrel, works in two
ways:

It prevents the release of an egg cell from the ovaries.

It causes changes in the cervix that make it difficult for sperm to
enter the womb.
As a result, Nexplanon protects you against pregnancy for a period of
three years, but if you are
overweight the doctor may advise you to replace the implant earlier

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nexplanon, 68mg implant for subdermal use
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nexplanon is a
radiopaque, non-biodegradable, progestagen-only,
flexible
implant preloaded in a sterile, disposable applicator.
Each radiopaque implant contains 68mg of etonogestrel; the release
rate is
approximately 60-70µg/day in week 5-6 and has decreased to
approximately
35-45µg/day at the end of the first year, to approximately
30-40µg/day at the
end of the second year and to approximately 25-30µg/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 a 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 4cm and 2mm 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 Nexplanon in adolescents under the age of
18 have not
been established.
Method of administration
PREGNANCY SHOULD BE EXCLUDED BEFORE INSERTION OF NEXPLANON.
IT IS STRONGLY RECOMMENDED THAT NEXPLANON BE INSERTED AND REMOVED ONLY
BY HEALTHCARE PROFESSIONALS (HCPS) WHO HAVE COMPLETED TRAINING FOR THE
USE OF THE NEXPLANON APPLICATOR AND THE TECHNIQUES FOR INSERTION AND
REMOVAL OF THE NEXPLANON IMPLANT, AND, WHERE APPROPRIATE, THAT
SUPERVISION BE REQUESTED PRIOR TO INSERTING OR REMOVING THE IMPLANT.
Before to inserting the implant, carefully read and follow the
instructions for
insertion and removal of the implant in section 4.2 How to insert
Nexplanon
and How to remove Nexplanon.
Videos demonstrating insertion and removal of the implant are
available
online at www.nexplanonvideos.eu.
Please contact you