PABAL

Země: Indonésie

Jazyk: indonéština

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

Aktivní složka:

CARBETOCIN

Dostupné s:

ABBOTT INDONESIA - Indonesia

INN (Mezinárodní Name):

CARBETOCIN

Dávkování:

0.1 MG

Léková forma:

INJEKSI

Jednotky v balení:

DUS, 5 VIAL @ 1 ML

Výrobce:

FERRING GMBH - Federal Republic of Germany

Datum autorizace:

2020-01-14

Charakteristika produktu

PROPOSED PACKAGING MATERIAL
Code
PABARTS-I-ID-01.02
Size
NA
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
PABARTS-I-ID-01.01
Changes
Following BPOM deficiency letter on 11 Jul 2019 to revise Indications,
Contraindications, Special
warnings and precautions, Interactions, and Preclinical Safety Data.
Reference

CCDS version: CCDS 2010/07 Version 02
and CMC related changes for RTS
formulation
☐
Core PIL version:
☐
SPC country/version/date:

LAC no.: 916 (19-Jul-2019)
Name & Date
INS, 8-Aug-2019
PABAL
CARBETOCIN
Solution for injection 100 mcg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbetocin 100 micrograms/ml.
Excipients:
L-Methionine, Succinic Acid, Mannitol, Sodium Hydroxide, Water for
injections.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
THERAPEUTIC INDICATIONS
Prevention of uterine atony following delivery of the infant by
Caesarean section under epidural or spinal
anaesthesia.
POSOLOGY AND METHOD OF ADMINISTRATION
Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and
administer only by intravenous injection, under
adequate medical supervision in a hospital.
A single dose of carbetocin must be administered slowly, over 1
minute, only after delivery of the infant by
Caesarean section. It should be given as soon as possible after
delivery, preferably before removal of the
placenta. No further doses of carbetocin should be administered
CONTRAINDICATIONS
•
Pregnancy and labour before delivery of the infant.
•
Induction of labour.
•
Serious cardiovascular disorders.
•
Hypersensitivity to carbetocin or oxytocin or any excipients.
•
Hepatic or renal disorder.
•
Preeclampsia and eclampsia.
•
Epilepsy.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Carbetocin is intended for use only at well-equipped specialist
obstetrics units with experienced and qualified staff
available at all times.
The use of carbetocin at any stage before delivery of the infant is
not appropriate because its uterotonic activity
persists for se