TRACTOCILE

País: Indonèsia

Idioma: indonesi

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

ingredients actius:

ATOSIBAN

Disponible des:

ABBOTT INDONESIA - Indonesia

Designació comuna internacional (DCI):

ATOSIBAN

Dosis:

6.75 Mg

formulario farmacéutico:

CAIRAN INJEKSI

Unidades en paquete:

DUS, 1 VIAL @ 0.9 ML

Fabricat per:

FERRING GMBH - Federal Republic of Germany

Data d'autorització:

2019-09-22

Fitxa tècnica

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