- Approval Id
- 9dc3c8d68fdddf08
- Drug Name
- BOOSTRIX VACCINE
- Product Name
- BOOSTRIX VACCINE
- Approval Number
- SIN11845P
- Approval Date
- 2002-03-09
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Posology</strong></p>
<p>A single 0.5 ml dose of the vaccine is recommended.</p>
<p><em><strong>Boostrix</strong></em> 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.</p>
<p><em><strong>Boostrix</strong></em> can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see <em>Pregnancy and Pharmacodynamics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Boostrix</strong></em> 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 <em>Pharmacodynamics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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.</p>
<p>Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as per official recommendations (generally 10 years).</p>
<p><em><strong>Boostrix</strong></em> 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.</p>
<p><strong>Method of administration</strong></p>
<p><em><strong>Boostrix</strong></em> is for deep intramuscular injection, preferably in the deltoid region (see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><em><strong>Boostrix</strong></em> is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see <em>Posology</em>).</p>
<p>The use of <em><strong>Boostrix</strong></em> should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em><strong>Boostrix</strong></em> should not be administered to subjects with known hypersensitivity to any component of the vaccine (see <em>Quantitative and Qualitative Composition</em> and <em>List of Excipients</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.</p>
<p><em><strong>Boostrix</strong></em> 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.</p>
<p><em><strong>Boostrix</strong></em> 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 <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07AJ52
- Atc Item Name
- pertussis, purified antigen, combinations with toxoids
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
