 Description
TYPBAR® is a sterile solution for intramuscular use containing the cell surface Vi polysaccharide extracted from Salmonella typhi Ty2 strain. The vaccine appears as a clear, colourless solution.
Composition
Each 0.5 ml dose contains - Vi Capsular polysaccharide of Salmonella typhi (Ty2 strain) 25 µg, Phenol and buffer solution containing sodium chloride, disodium phosphate, monosodium phosphate and water for injection.
Indications for Immunization
TYPBAR® is indicated for active immunization against typhoid fever for both adults and children two years of age or older. Selective immunization with TYPBAR® is recommended for the following:
- Travellers to high endemic areas
- Household contacts of carriers
- Healthcare personnel
- Police, Armed forces and such other regimented personnel
Contraindications
TYPBAR® should not be administered to subjects with known hypersensitivity to any component of the
vaccine or to subjects having shown signs of hypersensitivity after a previous administration.
Dosage Schedule
The immunizing dose for adults and children 2 years of age and older is a single dose of 0.5ml.
Subjects who remain at risk of typhoid fever should be given a single booster dose of the vaccine with an interval of not more than 3 years.
Method of Administration
TYPBAR® is for Intramuscular injection only. DO NOT inject intravenously. TYPBAR® in adults should be given intramuscularly in the deltoid and children should be injected intramuscularly either in the deltoid or the vastus lateralis. TYPBAR® should not be injected into the gluteal area or areas where there may be a nerve trunk.
Special Precautions and Warnings for Use
TYPBAR® protects against typhoid fever caused by Salmonella typhi. Protection is not conferred against Salmonella Paratyphi and other non-Typhoidal Salmonellae. Adrenaline injection must be kept readily available following immunization, should an anaphylactic or other allergic reaction occur due to any component of the vaccine. The administration of TYPBAR® should be delayed in subjects with acute infection or febrile illness.
TYPBAR® should be administered with caution to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration in these subjects. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Co-administration
TYPBAR® can be co-administered with other vaccines but should not be mixed with other vaccines or medicinal products in the same syringe.
Pregnancy & Lactation
The effect of the TYPBAR® on foetal development or reproduction capacity has not been evaluated. TYPBAR® should be given to a pregnant woman only if clearly needed. It is not known if TYPBAR® is excreted in human milk. It may be administered to nursing mothers only if clearly needed.
Adverse Reactions
Most recipients of typhoid vaccine experience some reactions upon vaccination. These are generally moderate and short in duration. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrohoea, vomiting myalgia and elevated temperature) are reported less commonly. In very rare cases, allergic - type reactions (pruritus, rash urticaria) may be observed.
Administration below 2yrs of age
Safety and effectiveness of TYPBAR® in children 2 years of age and below has not been established. Polysaccharide vaccines in general have lower immunogenicity under this age.
Presentation
TYPBAR® is presented in USP Type 1 glass vial. Single dose:0.5 ml, Multi-dose: 2.5 ml.
|
