Finished product reference
Diphtheria Toxoid / Tetanus Toxoid / Pertussis / Haemophilus Influenzae Type B / Hepatitis B Vaccine
Injection, Suspension · Parenteral · 5 dose
- List code
- 52461
- Pharmacologic class
- Combined pentavalent vaccine (DTP-HepB-Hib)
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.
Other presentations of the same active ingredient
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.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.