Diphtheria / Hemophilus Influenzae B / Pertussis / Poliomyelitis / Tetanus / Hepatitis B Vaccine

What it is and how it works

Contains diphtheria and tetanus toxoids, acellular pertussis antigens, inactivated poliovirus types 1–3, recombinant hepatitis B surface antigen and Haemophilus influenzae type b polysaccharide conjugated to a carrier protein, adsorbed on aluminium salts. It induces protective antibodies against all six diseases.

Indications

Primary and booster immunisation of infants and toddlers against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease caused by Haemophilus influenzae type b.

Dosage and administration (summary)

0.5 mL by intramuscular injection according to the national immunisation schedule (typically a primary series from 6–8 weeks of age with a booster in the second year).

Contraindications

Anaphylaxis after a previous dose or to any component (including neomycin, polymyxin or other trace residues); encephalopathy of unknown cause within 7 days of a previous pertussis-containing vaccine; progressive or uncontrolled neurological disorders until stabilised.

Warnings and precautions

Postpone in acute severe febrile illness. Fever, local reactions and, rarely, febrile convulsions or hypotonic–hyporesponsive episodes may occur; anaphylaxis treatment must be available. Apnoea monitoring is recommended when immunising very premature infants.

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.