Finished product reference
Influenza Vaccine, Recombinant, Tetravalent
Injection · Parenteral · 1 dose · 0.5 mL
- List code
- 53020
- Pharmacologic class
- Vaccine: recombinant quadrivalent influenza vaccine
What it is and how it works
Contains recombinant haemagglutinin (HA) proteins of two influenza A and two influenza B strains, produced in an insect cell line using a baculovirus expression system, without the use of eggs or live influenza virus. It induces antibodies against haemagglutinin that protect against infection with matching strains.
Indications
Active immunisation of adults (from 18 years) against seasonal influenza.
Dosage and administration (summary)
A single 0.5 mL dose by intramuscular injection, preferably into the deltoid, each influenza season.
Contraindications
Hypersensitivity to the active substances or excipients, or a severe reaction to a previous dose; postpone in acute febrile illness.
Warnings and precautions
Appropriate treatment for anaphylaxis should be available. Response may be reduced in immunosuppressed patients. Give with caution to patients with thrombocytopenia or coagulation disorders; syncope may occur after vaccination.
Pregnancy
Data are more limited than for inactivated egg-based vaccines; may be used in pregnancy when indicated after assessment of benefit and risk.
Storage and supply
Store at 2–8 °C; do not freeze; protect from light.
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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