IMPLANON NXT IMPLANT 68MG

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

(Core) Etonogestrel

Доступна з:

ORGANON SINGAPORE PTE. LTD.

Код атс:

G03AC08

Дозування:

68mg

Фармацевтична форма:

IMPLANT

Склад:

(Core) Etonogestrel 68mg

Адміністрація маршрут:

SUBCUTANEOUS

Тип рецепту:

Prescription Only

Виробник:

N.V. ORGANON

Статус Авторизація:

ACTIVE

Дата Авторизація:

2012-01-20

інформаційний буклет

IMPLANON 
NXT 
S-CCDS-MK8415-IPTX-032014 
            IMPLANT FOR SUBDERMAL USE 

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, 
ready-for-use, 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 
innovative 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 "List of excipients". 

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 indication 

Contraception. 

4.2 
Posology and method of administration 

Pregnancy should be excluded before insertion of Implanon 
NXT
. 

Healthcare professionals (HCPs) are strongly recommended to participate in
a training session to become 
familiar with the use of
the Implanon NXT applicator and techniques for insertion and removal of the 
Implanon NXT implant and where appropriate, request supervision prior to inserting or removing the implant. 

Prior to inserting the implant, carefully read and follow the instructions for insertion 
and removal of the implant in section 4.2.3 “How to insert Implanon 

Характеристики продукта

IMPLANON NXT®
S-CCDS-OG8415-IPTx-072023
Implant for subdermal use
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, ready-for-use, 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 innovative 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 "List of excipients".
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 indication
Contraception.
4.2
Posology and method of administration
Pregnancy should be excluded before insertion of Implanon NXT.
Healthcare professionals (HCPs) are strongly recommended to
participate in a
training session to become familiar with the use of the Implanon NXT
applicator
and the techniques for insertion and removal of the Implanon NXT
implant and,
where appropriate, request supervision 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 4.2.3 “How to insert
Implanon
NXT” and section 4.2.4 “How to remove Implanon NXT”.
Videos demonstrating insertion and removal of the implant are
available online
at www.implanonnxtvideos.com. Please contact Organon, Designated Point
of
Contact (DPOC) at [e-mail] if you have any
questions.
If you are unsure of the necessary steps to safely insert and/or
remove Implanon
NXT, do not atte