BOOSTRIX VACCINE [SIN11845P]

Product Info

BOOSTRIX VACCINE

[SIN11845P]

Indications

Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see Posology).

The use of Boostrix should be in accordance with official recommendations.

Dosage and Administration

Posology

A single 0.5 ml dose of the vaccine is recommended.

Boostrix can be given in accordance with the current local medical practices for booster vaccination with reduced-content combined diphtheria-tetanus vaccine, when a booster against pertussis is desired.

Boostrix can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see Pregnancy and Pharmacodynamics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Boostrix may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus and pertussis (see Pharmacodynamics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus.

Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as per official recommendations (generally 10 years).

Boostrix can be used in the management of tetanus-prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.

Method of administration

Boostrix is for deep intramuscular injection, preferably in the deltoid region (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Boostrix should not be administered to subjects with known hypersensitivity to any component of the vaccine (see Quantitative and Qualitative Composition and List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.

Boostrix is contraindicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria and tetanus vaccines.

Boostrix should not be administered to subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus (for convulsions or hypotonic-hyporesponsive episodes, see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).