BCG vaccine powder lyophilized for solution for injection

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

BCG vaccine(Bacillus Calmette Guerin Strain)

Verfügbar ab:

Serum Institute of India Pvt. Ltd.

ATC-Code:

J07AN01

INN (Internationale Bezeichnung):

BCG vaccine(Bacillus Calmette Guerin Strain)

Dosierung:

between 2x10^5 and 8x10^5 CFU/0,1ml

Darreichungsform:

powder lyophilized for solution for injection

Einheiten im Paket:

(50) 10/20 dose glass vial/ (50/5x10/) sodium chloride 0.9% 1ml ampoules with solvent in blister, (300/6 box/)(50) 10/20 dose gl

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2017-10-23

Gebrauchsinformation

Sii
Sii
DESCRIPTION
BCG Vaccine is a live freeze-dried vaccine derived from attenuated
strain of Mycobacterium bovis
(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 re-suspend freeze dried BCG.
Gently swirl the vial of
re-suspended vaccine before drawing up each subsequent dose. The
resulting suspension should be
homogenous, slightly opaque and colourless. The reconstituted
suspension may occasionally show
clumps, which is normal characteristic of Mycobacterium bovis. Avoid
vigorous shaking which may
enhance/aggrevate clumps formation. Reconstitute only with diluent
provided by manufacturer. Using
an incorrect diluent may result in damage to the vaccine and / or
serious reactions to those receiving
the vaccine. Use immediately after reconstitution. If the vaccine is
not used immediately then it must
be stored in the dark at 2 - 8 º C for no longer than 6 hours (1
immunisation session).
Any opened vial remaining at the end of a vaccination session (within
six hours of reconstitution) must
be discarded. The vaccine vial monitor for this type of vaccine i

Fachinformation

SERUM INSTITUTE OF
INDIA PVT. LTD.
BCG VACCINE (FREEZE DRIED),
1 ML (0.05 ML X 20 DOSE/0.1 ML X 10 DOSE)
SPC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
BCG Vaccine (Freeze Dried),
1 ml (0.1 ml x 10 dose / 0.05 ml x 20 dose)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BCG
Vaccine
is
a
live
freeze-dried
vaccine
derived
from
attenuated
strain
of
_Mycobacterium bovis_. (Bacillus Calmette Guerin 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).
BCG vaccine (Freeze-Dried)-10/20 doses, contains of a lyophilized
powder and a diluent
for reconstitution (Sodium Chloride Injection B.P. (0.9% w/v), 1 ml).
COMPOSITION
Live, attenuated BCG Vaccine (Bacillus Calmette Guerin Strain)
Each 0.1 ml contains between : 2 x 10
5
and 8 x 10
5
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.
3. PHARMACEUTICAL FORM
Freeze-dried powder for injection
(Supplied with diluent separately i.e. sodium chloride injection B.P.
(0.9% w/v), 1 ml in USP Type-1 glass ampoules)
4. CLINICAL DATA
4.1. THERAPEUTIC INDICATIONS
BCG vaccine should be given routinely to all infants at risk of early
exposure to
tuberculosis. This vaccine should be given soon after the child is
born. BCG administered
early in life provides high level of protection particularly against
severe forms of
childhood tuberculosis and tubercular meningitis. In countries with
low prevalance of
tuberculosis, BCG vaccination should be restricted to high risk groups
such as hospital
personnel and tuberculin negative contacts of known cases of
tuberculosis. The vaccine
can
be
given
simultaneously
with
DTP,
DT,
TT,
Measles,
Polio,
Hepatitis
B,
Haemophilus influenzae type b, yellow fever vaccines and vita