POLIO SABIN (ORAL) VACCINE

Country: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

POLIOMYELITIS VIRUS (SABIN STRAIN) TYPE min 1000000 TCID50/0.5 ml

Disponibbli minn:

GLAXOSMITHKLINE PTE LTD

Kodiċi ATC:

J07BF02

Dożaġġ:

min 1000000 TCID50/0.5 ml

Għamla farmaċewtika:

SUSPENSION

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

GLAXOSMITHKLINE BIOLOGICALS SA

Data ta 'l-awtorizzazzjoni:

1988-06-24

Fuljett ta 'informazzjoni

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PROPOSED PACKAGE INSERT  
POLIO SABIN™ (ORAL) 
TRIVALENT ORAL POLIOMYELITIS VACCINE (LIVE, ATTENUATED) SABIN
STRAINS 
QUALITATIVE AND QUANTITATIVE COMPOSITION

POLIO SABIN™ (oral) vaccine is a stabilised preparation of
live attenuated poliomyelitis 
viruses of the Sabin strains type 1 (LSc, 2ab), type 2 (P712 ch,
2ab) and type 3 (Leon 12a, 
1b), propagated in MRC5 human diploid cells.POLIO SABIN™ (oral)
meets the World Health 
Organisation requirements for biological substances and for
poliomyelitis vaccine (oral). 
THE APPROPRIATE FORMULATION SHOULD BE CHOSEN IN
ACCORDANCE WITH NATIONAL 
RECOMMENDATIONS. 
For example: 
WHO/EPI recommends that each immunising dose of vaccine
contains not less than: 106.0 
CCID50 for type 1, 105.0 CCID50 for type 2, and 105.8 CCID50 for
type 3 live attenuated 
Sabin strains of polioviruses.  
European Pharmacopoeia recommends that each immunising dose
of vaccine contains not 
less than: 106.0 CCID50 for type 1, 105.0 CCID50 for type 2 and
105.5 CCID50 for type 3 
live attenuated Sabin strains of polioviruses. 

PHARMACEUTICAL FORM

Oral suspension. 
The vaccine is presented as clear liquid,
yellowish-pink suspension for oral administration. 

CLINICAL PARTICULARS

INDICATIONS

POLIO SABIN™ (oral) is indicated for active immunisation
of infants and susceptible children 
and adults against infection caused by polioviruses of type 1, 2 and
3. 

DOSAGE AND ADMINISTRATION 
POSOLOGY 
In a multidose container, one immunising dose (0.1 ml) is contained
in two drops. 
AS VACCINATION SCHEMES VARY FROM COUNTRY TO COUNTRY, THE ADVISED
SCHEDULE FOR EACH 
COUNTRY MUST BE IN ACCORDANCE WITH THE NATIONAL RECOMMENDATIONS. 
INFANTS:  The primary immunisation course is three doses of POLIO
SABIN™ (oral) vaccine. 
The vaccine should be administered with an interval of at least
one month between doses. 
POLIO SABIN™ (oral) may be given at birt