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AFLUNOV SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE [SIN14400P]
Active ingredients: AFLUNOV SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE
Last updated 26 October 2025
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AFLUNOV SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE
[SIN14400P]
Product information
Active Ingredient and Strength | INFLUENZA VIRUS SURFACE ANTIGENS (HAEMAGGLUTININ AND NEURAMINIDASE) A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN USED (NIBRG-23) - 7.5 MCG HA/0.5 ML |
Dosage Form | INJECTION, SUSPENSION |
Manufacturer and Country | SEQIRUS VACCINES LIMITED (FORMULATION, FILL/FINISH, PRIMARY & SECONDARY PACKAGING) - UNITED KINGDOM |
Registration Number | SIN14400P |
Licence Holder | SEQIRUS PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BB02 |
4.1 Therapeutic indications
Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
AFLUNOV® should be used in accordance with official recommendations.
4.2 Posology and method of administration
Posology:
Adults and elderly (18 years of age and above):
Individuals 18 years and older: Two 0.5 mL doses administered with an interval of at least 21 days between doses.
In the event of an officially declared influenza pandemic due to H5N1 virus, persons previously vaccinated with one or two doses of AFLUNOV® that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of adjuvanted H5N1 pandemic vaccine instead of two doses that are required in previously unvaccinated individuals (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population:
There is limited experience in children between 6 months and 17 years of age (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Method of administration
Immunisation should be carried out by intramuscular injection into the deltoid muscle.
4.3 Contraindications
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (ovalbumin from eggs, kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and hydrocortisone) of this vaccine.
However, in a pandemic situation caused by the strain included in this vaccine, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need.