BCG VACCINE

Country: Ինդոնեզիա

language: ինդոնեզերեն

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

active_ingredient:

BCG VACCINE

MAH:

BIO FARMA - Indonesia

INN:

BCG VACCINE

pharmaceutical_form:

SERBUK INJEKSI

units_in_package:

DUS, 50 VIAL @ 20 DOSIS + PELARUT

manufactured_by:

SERUM Institute - India

authorization_date:

2018-07-10

SPC

Item Code number:
Colour: Pantone Process Blue C and Pantone 072 C
Dimensions: 123 x 247 mm
Product:
Reason for issue: Text revised
Customer: Indonesia
Specification No.:
Artwork made to: 100%
QUALITY
CONTROL
PACKAGING
DEVELOPMENT
REGULATORY
AFFAIRS
QUALITY
ASSURANCE
File Name: E:\Packaging artworks as on 090212\Artworks SII Pvt Ltd
231015\Insert\Indonesia\BCG Vaccine 4 folds, Indonesia Final.cdr Date:
07.10.17
035 5205/8/F3
Supercedes Item Code:
MEDICAL
DEPARTMENT
BCG VACCINE
Specification: To be printed on bible
40 gsm.
paper
20011954/3
20011954/2
“On medical prescription only” Reg. No.: DKI1340300144A1
Imported by : PT Bio Farma (Persero)
Jl. Pasteur No. 28, Bandung, Indonesia
SII
BCG VACCINE
(Freeze-Dried)
DESCRIPTION
BCG Vaccine is a live freeze-dried vaccine derived from attenuated
strain of _Mycobacterium bovi_s
(Bacillus
Calmette
Guerin
Moscow
strain
361-
I)
used
for
the
prevention
of
tuberculosis.
The freeze-dried vaccine is white and crystalline in appearance. It
contains Sodium Glutamate
as stabilizer. The vaccine meets the requirements of W.H.O. when
tested by the methods outlined in
W.H.O., TRS. 979 (2013).
COMPOSITION
Live, attenuated BCG Vaccine (Bacillus Calmette Guerin Strain)
5
5
Each 0.1 ml contains between : 2 x 10 and 8 x 10 C.F.U.
Reconstitute with Sodium Chloride Injection
Dose : 0.05 ml, Intradermal for infants under one year old.
: 0.1 ml, Intradermal for children over one year of age and adult.
RECONSTITUTION
Tap the vaccine vial gently so as to get the white and crystalline
vaccine powder at the bottom of the
vial. BCG vaccine vial of 20 doses (0.05 ml) for infants under one
year old /10 doses (0.1 ml) for children
over one year of age and adult to be reconstituted by adding the
entire content of the supplied
container of diluent (Sodium Chloride Injection).
Carefully invert the vial a few times to resuspend freeze dried BCG.
Gently swirl the vial of
resuspended vaccine before drawing up each subsequent dose. The
resulting suspension should be
homogenous, slightly opaque and colourl