IMPLANON NXT

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

ETONOGESTREL

Tersedia dari:

LTT Pharma Limited

Kode ATC:

G03AC08

INN (Nama Internasional):

ETONOGESTREL

Dosis:

68 Milligram

Bentuk farmasi:

Implant

Jenis Resep:

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

Area terapi:

etonogestrel

Status otorisasi:

Authorised

Tanggal Otorisasi:

2014-09-12

Selebaran informasi

•
The implant should only be removed by a qualified healthcare
professional who is familiar with the procedure.
•
The implant is removed at your request or -AT THE LATEST- THREE YEARS
AFTER INSERTION.
•
The location of the insertion site of the implant is indicated on the
User
card.
•
The healthcare professional will locate the implant. If the implant
can not be located the healthcare professional may have to use X-ray,
CT, ultrasound or magnetic resonance imaging techniques.
IMPLANON NXT 68MG IMPLANT FOR SUBDERMAL USE
PATIENT INFORMATION 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:
What Implanon NXT is and what it is used for
What you need to know before you use Implanon NXT
How to use Implanon NXT
Possible side effects
How to store Implanon NXT
Contents of the pack and other information
Information for the health care professional
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, 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 PR

Karakteristik produk

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 The Netherlands_
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 vinylacetate 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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