Diphtheria Toxoid / Tetanus Toxoid / Pertussis / Haemophilus Influenzae Type B / Hepatitis B Vaccine

What it is and how it works

Contains diphtheria and tetanus toxoids, pertussis antigens (usually whole-cell), recombinant hepatitis B surface antigen and Haemophilus influenzae type b conjugate polysaccharide, adsorbed on aluminium salts. It induces protective antibodies against the five diseases.

Indications

Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B and invasive Haemophilus influenzae type b disease, as part of national immunisation programmes.

Dosage and administration (summary)

0.5 mL by intramuscular injection according to the national immunisation schedule (typically three doses in infancy, for example at 2, 4 and 6 months).

Contraindications

Anaphylaxis after a previous dose or to any component; encephalopathy of unknown cause within 7 days of a previous pertussis-containing vaccine; progressive neurological disorders until stabilised.

Warnings and precautions

Postpone in acute severe febrile illness. Fever, local reactions, persistent crying and, rarely, febrile convulsions or hypotonic–hyporesponsive episodes may occur, more often with whole-cell pertussis; anaphylaxis treatment must be available. Not intended for adults or for the hepatitis B birth dose.

Storage and supply

Store refrigerated at 2–8 °C; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.