TRACTOCILE

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

ATOSIBAN

Tersedia dari:

ABBOTT INDONESIA - Indonesia

INN (Nama Internasional):

ATOSIBAN

Dosis:

6.75 Mg

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 0.9 ML

Diproduksi oleh:

FERRING GMBH - Federal Republic of Germany

Tanggal Otorisasi:

2019-09-22

Karakteristik produk

PROPOSED PACKAGING MATERIAL
Code
TRAC09,5-I-ID-02.02
Size
NA
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
TRAC09,5-I-ID-02.01
Changes
Revision indication and warning refer to PN.01.01.322.12.18.00913/N
date 28-Dec-2018
Reference
☐
CCDS version:
☐
Core PIL version:
☒
SPC country/version/date:
EMA approved
SmPC. Date of approval: 13-Jan-2016
☒
LAC no.: LAC 764 ID
Name & Date
INS, 25-Jan-2019
TRACTOCILE
®
ATOSIBAN
7.5 MG/ML SOLUTION FOR INJECTION
7.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution for injection
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Concentrate for solution for infusion
Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Each ml of solution contains 7.5 mg atosiban.
After dilution, the concentration of atosiban is 0.75 mg/ml.
Excipients: Mannitol, hydrochloric acid 1M and water for injections.
PHARMACEUTICAL FORM
Solution for injection
Solution for injection (injection).
Clear, colourless solution without particles.
Concentrate for solution for infusion
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless solution without particles.
THERAPEUTIC INDICATIONS
Tractocile is indicated to delay imminent pre-term birth in pregnant
women with:
•
regular uterine contractions of at least 30 seconds duration at a rate
of
≥
4 per 30 minutes
•
a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement
of
≥
50%
•
age
≥
18 years
•
a gestational age from 24 until 33 completed weeks
•
a normal foetal heart rate
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Tractocile should be initiated and maintained by a
physician experienced in the
treatment of pre-term labour.
Tractocile
is administered intravenously in three successive stages: an initial
bolus dose (6.75 mg),
performed with Tractocile 6.75 mg/0.9 ml solution for injection,
immediately followed by a continuous
high dose infusion (loading infusion 300 mic