Table 1: FluQuadri Ingredients Ingredient Quantity (per dose) FluQuadri Junior 0.25 mL Dose FluQuadri 0.5 mL Dose Active Substance: Influenza virus haemagglutinina: 30 µg HA 60 µg HA total A (H1N1) 7.5 µg HA 15 µg HA A (H3N2) 7.5 µg HA 15 µg HA B (Victoria lineage) 7.5 µg HA 15 µg HA B (Yamagata lineage) 7.5 µg HA 15 µg HA Sodium chloride 2.2 µg 4.4 µg Sodium phosphate dibasic anhydrous 165.8 µg 331.5 µg Sodium phosphate monobasic anhydrous 50 µg 100 µg Water for injections Up to 0.25 mL Up to 0.5 mL Formaldehyde ≤ 50 µg ≤ 100 µg Octoxinol 9 ≤ 125 µg ≤ 250 µg Ovalbumin ≤ 0.5 µg ≤ 1 µg Preservative None None aper AIVC and WHO recommendations PHARMACOLOGY Mechanism of action FluQuadri provides active immunisation against the four influenza virus strains (two A subtypes and two B strains) contained in the vaccine. FluQuadri induces humoral antibodies against the haemagglutinins. Specific levels of haemagglutination-inhibition (HI) antibody titre with inactivated influenza virus vaccines have not been correlated with protection from influenza illness, but HI antibody titres have been used as a measure of vaccine activity. In some human challenge studies, HI antibody titres of ≥ 1:40 have been associated with protection from influenza illness in up to 50% of participants. HI antibody titres ≥ 1:40 are generally obtained within 3 to 4 weeks. Annual influenza vaccination is recommended as immunity declines during the year after vaccination and because circulating strains of influenza virus may change from year to year.
exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone. Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema) Eye disorders: Ocular hyperemia Nervous System Disorders: syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia Vascular Disorders: Vasculitis, vasodilation/flushing Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain Gastrointestinal Disorders: Vomiting DOSAGE AND ADMINISTRATION FluQuadri/FluQuadri Junior should be given in accordance with the national recommendation as per the current Immunisation Handbook. Administration should be carried out by the intramuscular route. The dose and schedule are as follows: Children aged 6 months to 35 months: 0.25 mL dose Children and adults 3 years of age and older 0.5 mL dose For children who have not been adequately primed based on influenza vaccination history, a second dose should be administered approximately 4 weeks apart. Refer to the current Immunisation Handbook for the recommended doses of influenza vaccine for young children at different ages. Inspect FluQuadri/FluQuadri Junior visually for particulate matter and/or discolouration prior to administration. If any of these defects or conditions exist, the vaccine should not be administered. Before administering a dose of vaccine, shake the prefilled syringe. The syringe is for single use only and must not be reused.