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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
diTeBooster, suspension for injection.
Diphtheria and tetanus vaccine (absorbed, reduced antigen content).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose
= 0.5 ml:
Diphtheria Toxoid, purified
6.25 Lf / > 2 I.U.
Tetanus Toxoid, purified
6.25 Lf / > 20 I.U.
Aluminium hydroxide, hydrated,
corr. to aluminium content
0.5 mg
The diphtheria and tetanus toxins, obtained from cultures of _Corynebacterium diphtheriae _and _Clostridium tetani, _are
purified and detoxified.
The two toxoids are adsorbed to aluminium hydroxide.
No substances of human origin are used during the vaccine manufacture.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in single-dose vials.
Colourless suspension of white/ grey particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Re-vaccination of children ( 5 years of age) and adults who have previously received primary immunisation of at least
3 doses of diphtheria and tetanus vaccine.
diTeBooster is not intended for primary immunisation against diphtheria and tetanus.
The use of diTeBooster should be in accordance with official national recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In comparison with a vaccine for primary immunisation diTeBooster contains reduced amounts of diphtheria and
tetanus antigens, and the vaccine should be administered in accordance with national official recommendations
regarding the use of such vaccines.
The necessary precautions for treatment of anaphylactic reactions should always be taken.
Shake before use.
diTeBooster should be administered intramuscularly as a single dose of 0.5 ml.
At certain indications (for example haemorrhagic diathesis) diTebooster can be administered deep subcutaneously.
Clinical studies
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