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Introduction
  • FLUARIX TETRA is an inactivated and purified split influenza vaccine.
  • FLUARIX TETRA 0.5 mL dose of contains 15 micrograms haemagglutinin. The antigen composition and strains for the 2022 influenza season corresponds to the following the four types of influenza virus fragments (in phosphate buffered saline):
    • A/Victoria/2570/2019 (H1N1)pdm09-like virus
    • A/Darwin/9/2021 (H3N2)-like virus
    • B/Austria/1359417/2021-like (B/Victoria lineage) virus
    • B/Phuket/3073/2013-like (B/Yamagata lineage) virus
Indications
  • A person who requires immunisation against seasonal Influenza (recommended annually).
Contraindications
  • Past history of Guillain-Barré syndrome
  • FLUARIX TETRA should not be administered to individuals with known hypersensitivity after previous administration of FLUARIX TETRA or influenza vaccines or to any component of the vaccine.
Precautions / Notes
  • Patients must be well on the day of vaccination and provide voluntary consent prior to receiving the vaccination.
  • FLUARIX TETRA should under no circumstances be administered intravascularly.
  • As with other vaccines, vaccination with FLUARIX TETRA should be postponed in individuals suffering from an acute severe febrile illness.
  • Adverse event following immunisation (AEFI) may occur. These AEFI must be reported to WA Department of Health through the Western Australian Vaccine Safety Surveillance (WAVSS) reporting system.

Cold chain

  • It is essential to maintain cold chain while storing and transporting flu vaccines. Vaccines must be kept between +2°C and +8°C as they could otherwise become breached and not suitable for use.
  • The cold chain begins from the time the vaccine is manufactured, continues through to state or territory vaccine distribution centres and immunisation service providers, and ends when the vaccine is administered.
  • Purpose built vaccine refrigerators are specifically designed to store and transport vaccines safely.
  • Vaccine refrigerators should include a data logger to monitor the temperature in 5-minute intervals. Twice daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in cold chain.

Cold Chain Breach

  • A cold chain breach occurs when vaccine storage temperatures deviate outside the recommended range of +2°C to +8°C. The optimal storage temperature for vaccines is +5°C.
  • All vaccine temperatures recorded below +2°C or above +8°C must be reported to WA Department of Health.
    • This does not include temperature deviations or excursions in which the temperature reaches a maximum of up to +12°C for 15 minutes or less.
    • Any deviation below +2°C must be reported.

What to do if there is a Cold Chain Breach

  • Immediately isolate the breached vaccines in temporary vaccine storage and label them ‘Do Not Use’.
  • Contact WA Health (or if purchased privately, the manufacturer) and advise them of the breach. Information to include:
    • Date and time of breach
    • Reason for breach and if it has rectified
    • Brand and size of refrigerator in which the vaccines are stored.
    • Information from the breach period that has been downloaded from the data logger
    • Maximum and minimum temperatures that the vaccines reached during the breach
    • Length of time refrigerator was outside of +2°C to +8°C range
    • Date of last refrigeration service and whether the fridge has had any maintenance issues recently
    • Type of vaccine, expiry date, and number of vaccines that were breached
    • Whether any vaccines have been pushed up against the cooling plate or a cold air outlet
    • Whether all vaccines are in their original packaging
    • Whether anybody has been vaccinated with potentially affected vaccines
    • Whether there is any visible damage to vaccines (eg wet or soggy packaging)
  • Do not use or discard vaccines until advised by WA Health or the manufacturer.
Management
All staff administering this medication must observe and comply with the Structured Administration and Supply Arrangement linked.
Special Considerations
  • Mild and short-lasting side effects. These can include but are not limited to:
    • Pain
    • Redness and swelling at the injection site
    • Low grade temperature, and/or
    • Muscle aches

References
References
Presentation
  • Pre-filled syringe in pack of 1 and 10.
  • Colourless slightly opalescent liquid.
  • Pharmaceutical form: Suspension for injection.

The vaccine also contains:

  • polysorbate 80
  • octoxinol 10
  • dl-alpha-tocopheryl hydrogen succinate
  • sodium chloride
  • dibasic sodium phosphate dodecahydrate
  • potassium dihydrogen phosphate
  • potassium chloride
  • magnesium chloride hexahydrate
  • water for injections
  • ovalbumin (≤0.05 micrograms) (trace)
  • formaldehyde (≤5 micrograms) (trace)
  • hydrocortisone (trace)
  • gentamicin sulphate (trace)
  • sodium deoxycholate (trace)
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