Implanon NXT, 68 mg implant for subdermal use

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Etonogestrel

זמין מ:

IMED Healthcare Ltd.

קוד ATC:

G03AC; G03AC08

INN (שם בינלאומי):

Etonogestrel

כמות:

68 milligram(s)

טופס פרצבטיות:

Implant

סוג מרשם:

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

איזור תרפויטי:

Progestogens; etonogestrel

מצב אישור:

Authorised

תאריך אישור:

2016-05-06

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
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 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 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 period of three years, but if you are
overweight the doctor may advise you to

מאפייני מוצר

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
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
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