Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION
**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_).
INTRAMUSCULAR
Medical Information
**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.
**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_).
J07AJ52
pertussis, purified antigen, combinations with toxoids
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals SA
Active Ingredients
FILAMENTOUS HAEMAGGLUTININ
8 mcg/0.5 ml
PERTUSSIS TOXOID
8 mcg/0.5 ml
Documents
Package Inserts
Boostrix PI.pdf
Approved: May 29, 2023