Finished product reference

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

Injection, Suspension · Parenteral · 10 dose · 5 mL

List code
16491
Pharmacologic class
Combined tetravalent vaccine (DTP-Hib)

What it is and how it works

Contains diphtheria and tetanus toxoids, pertussis antigens and Haemophilus influenzae type b capsular polysaccharide conjugated to a carrier protein, adsorbed on aluminium salts. It induces protective antibodies against diphtheria, tetanus, pertussis and invasive Hib disease.

Indications

Primary and booster immunisation of infants and young children against diphtheria, tetanus, pertussis and invasive Haemophilus influenzae type b disease.

Dosage and administration (summary)

0.5 mL by intramuscular injection according to the national immunisation schedule.

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 and, rarely, febrile convulsions or hypotonic–hyporesponsive episodes may occur; anaphylaxis treatment must be available. Does not protect against hepatitis B or poliomyelitis, which require separate vaccines.

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.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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