(nasal spray, suspension influenza
vaccine (live attenuated, nasal))

Part Five

Post-Administration

What side effects can occur with Fluenz Tetra?

Fluenz Tetra was licensed based on trivalent Fluenz vaccine tolerability data.
The tolerability for Fluenz is relevant to Fluenz Tetra because both use the same
manufacturing process. The only difference between them is the addition of a fourth
influenza strain (a second B strain) to Fluenz Tetra.

In clinical studies, the tolerability profile of Fluenz Tetra was similar to that of Fluenz.
Safety data regarding the use of Fluenz Tetra are based on data from Fluenz Tetra
clinical studies in 2,231 children and adolescents 2 to 17 years of age, Fluenz clinical
studies in over 29,000 children and adolescents 2 to 17 years of age and Fluenz
post-authorisation safety studies in over 84,000 children and adolescents 2 to 17
years of age. Additional experience has occurred with marketed use of Fluenz.

The most common adverse events, occurring in at least 1 in 10 recipients, are nasal
congestion/rhinorrhoea, headache, decreased appetite and malaise (the technical
term for feeling generally unwell).

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to AstraZeneca by visiting https://aereporting.astrazeneca.com or by calling 0800 783 0033.

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Prescribing Information