Implanon NXT 68 mg implant for subdermal use

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Etonogestrel

Tersedia dari:

Imbat Limited

Kode ATC:

G03AC; G03AC08

INN (Nama Internasional):

Etonogestrel

Dosis:

68 milligram(s)

Bentuk farmasi:

Implant

Jenis Resep:

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

Area terapi:

Progestogens; etonogestrel

Status otorisasi:

Authorised

Tanggal Otorisasi:

2009-05-22

Selebaran informasi

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMPLANON NXT
®
, 68MG IMPLANT FOR SUBDERMAL USE
(etonogestrel)
Your medicine is available using the above name but will be referred
to as Implanon NXT
throughout this leaflet.
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 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
1.
WHAT IMPLANON NXT IS AND WHAT IT IS USED FOR
Implanon NXT 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,
4cm in length and 2mm 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 sulfate 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 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, Implanon NXT protects you against pregnancy for a per

Karakteristik produk

Health Products Regulatory Authority
21 May 2019
CRN008Z10
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant for subdermal use
_Product imported from the UK: _
Radiopaque, non-biodegradable white to off-white, soft flexible rod
with a length of 4 cm and 2mm 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
Ethylene vinylacetate copolymer
Barium sulfate
Magnesium stearate
Health Products Regulatory Authority
21 May 2019
CRN008Z10
Page 2 of 2
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.
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
Over-labelled cardboard carton containing one implant in the cannula
of a disposable sterile applicator.
Pack size: 1 applicator containing 1 implant
The content of the blister pack is sterile unless the package is
damaged or opene