IMPLANON NXT

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

ETONOGESTREL

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

ETONOGESTREL

Dosis:

68 MG

Bentuk farmasi:

SUBDERMAL IMPLANTS

Unit dalam paket:

DUS, 1 BLISTER @ 1 APLIKATOR PRELOADED DENGAN 1 IMPLANT

Diproduksi oleh:

N.V. ORGANON - Netherlands

Tanggal Otorisasi:

2021-08-05

Karakteristik produk

IMPLANON NXT
®
Etonogestrel
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
DISETUJUI OLEH BPOM: 22/06/2021
ID REG: EREG100373VR12100084
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
”.
Video demonstrating insertion and removal of the implant are available
online
(www.ImplanonNXTvideos.com).
Please
contact
PT
Organon
Pharma Indonesia Tbk, Jakarta. Telephone : [phone]; Fax : (021)
31107020 if you have any questions.
If you are unsure of the neces