Typhocon

Typhocon is indicated for active immunization against infection caused by Salmonella typhi in infants, children, adolescents and adults aged >6 months to <45 years.

A single 0.5 mL dose of the vaccine should be administered intramuscularly in the deltoid muscle of upper arm if muscle mass is adequate for children 2 years and above, adolescents and adults. For infants and toddlers aged >6 months to <2 years of age, the vaccine should be administered intramuscularly in the vastus lateralis muscle on anterolateral aspect of thigh. This vaccine should not be injected into the gluteal area or in any areas where there may be a nerve trunk.

Typhoid Vi Conjugate Vaccine is a clear, colourless solution, free from visible particulate matter. The vaccine contains 25 mcg of Typhoid Vi polysaccharide conjugated to CRMt97. The polysaccharide is manufactured using Citrobacter freundii sensu lato 3056 (Vi) and is conjugated to CRM

197

as a carrier protein. Sodium Chloride and Phosphate Buffer are used as a diluent (buffering agent) in vaccine formulation. 2-Phenoxyethanol is added as a preservative. BE's Typhoid Vi Conjugate Vaccine can be administered in single 0.5 mL intramuscular dose to infants, children, adolescents and adults aged >6 months to <45 years.The vaccine meets the requirements of I.P. and WHO.

The most frequently reported local adverse events after administration of Biological E's Typhocon Vi Conjugate vaccine were Injection Site Pain (4.50%), Injection Site erythema (0.64%) and Injection site Swelling (0.32%). These usually occurred within first 48 hours and disappeared within 2-3 days. The most frequently reported systemic adverse events were Pyrexia (2.25%), Vomiting (0.96%), Headache (0.64%), Fatigue (0.64%), Arthralgia (0.32%) and Rash (0.32%). No vaccine-related serious adverse events (SAEs) were reported in the clinical trial.

• Hypersensitivity to any component of vaccine
• Pregnant & lactating women
• In case of fever and severe infection

Do not administer intravenously, intradermally or subcutaneously.

Typhocon protects against typhoid fever caused by Salmonella typhi. Protection is not conferred against Salmonella paratyphi and other non typhoidal Salmonellae.

Adrenaline (epinephrine) injection, 1:1000 (1 mg/mL) must be immediately available in case of an acute anaphylactic reaction or any allergic reaction occurs due to any component of the vaccine. The vaccinee should remain under medical supervision for not less than 30 minutes after vaccination. Like all other vaccines, supervision and appropriate medical treatment should always be available to treat any anaphylactic reactions following immunization.

Safety and effectiveness have not been established in pregnant women and in nursing mothers. It is not known whether the vaccine is excreted in human milk.

As on date there is no clinical data on co-administration of this vaccine. Hence, Biological E's Typhocon Vi conjugate vaccine should not be mixed with any other vaccine or medicinal product. For concomitant administration use different injection sites and separate syringes.

Store at +2°C to +8°C. Do not freeze. Discard if found frozen. Shake well before use. Keep out of reach of children.