TYPHERIX VI POLYSACCHARIDE TYPHOID VACCINE

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PURIFIED VI CAPSULAR P/S OF S.TYPHI

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

PURIFIED VI CAPSULAR P/S OF S.TYPHI

Units in package:

3ml1Units mL; 3 ml 1 Units mL; 3 ml 10 Units mL

Manufactured by:

GLAXOSMITHKLINE BIOLOGICALS S.A

Summary of Product characteristics

Typherix TM
Vi polysaccharide typhoid vaccine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Typherix TM is a clear isotonic colourless solution containing the cell surface Vi
polysaccharide extracted from Salmonella typhi Ty2 strain.
Typherix
TM complies with WHO and European Pharmacopoeia monograph requirements for
Vi polysaccharide typhoid vaccines.
Each 0.5 ml dose of vaccine contains 25 g of the Vi polysaccharide of Salmonella typhi.
PHARMACEUTICAL FORM Solution for injection.
CLINICAL PARTICULARS
Indications
Active immunisation against typhoid fever for adults and children older than two years of
age.
Dosage and Administration
Posology
A single dose of 0.5 ml containing 25 g of the Vi polysaccharide of Salmonella typhi is
recommended for both children and adults.
Subjects who remain at risk of typhoid fever should be revaccinated using a single dose of
vaccine every 3 years.
Method of administration
Typherix TM is for intramuscular injection.
Typherix TM should be administered with caution to subjects with thrombocytopenia or
bleeding
disorders since bleeding may occur following an intramuscular administration to these
subjects: following injection, firm pressure should be applied to the site (without rubbing) for
at least two minutes.
Contraindications
Typherix
TM should not be administered to subjects with known hypersensitivity to any
component of the vaccine or to subjects having shown signs of hypersensitivity after previous
administration.
Warnings and Precautions As with other vaccines, the administration of Typherix TM
should be postponed in subjects suffering from acute febrile illness.
The vaccine protects against typhoid fever caused by Salmonella typhi. Protection is not
conferred against paratyphoid fever or illness caused by non-invasive Salmonellae.
Typherix
TM has not been evaluated in children under 2 years of age. Nevertheless, it is
known that children under this age may show a suboptimal response to polysaccharide
antigen vaccines. The decision to use the vaccine in this age group should