Prophylaxis of influenza (flu), particularly in individuals at higher risk of complications. The use of inactivated influenza vaccine should follow official recommendations.

Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilized hen’s eggs from healthy chicken flocks and inactivated with formaldehyde, from the following strains:

• A/California/07/2009 (H1N1)-like strain (A/California/07/2009, NYMC X-181): 15 micrograms haemagglutinin
• A/Perth/16/2009 (H3N2)-like strain (A/Victoria/210/2009, NYMC X-187): 15 micrograms haemagglutinin
• B/Brisbane/60/2008-like strain (B/Brisbane/60/2008): 15 micrograms haemagglutinin

Dosage:

• Adults and children above 36 months: 0.5 mL
• Children aged 6 to 35 months: Limited clinical data available; doses of 0.25 mL or 0.5 mL have been used

Administration: For children who have not previously been vaccinated, a second dose should be administered after an interval of at least 4 weeks. If a half dose (0.25 mL) is required, discard half of the volume (up to the indicated mark on the syringe) before injection. Immunization should be given by intramuscular or deep subcutaneous injection. The vaccine should be brought to room temperature before use and shaken well prior to administration. Seroprotection is generally achieved within 2 to 3 weeks. The duration of immunity against the same or closely related strains usually lasts for 6 to 12 months.

Inactivated Influenza Vaccine can be administered alongside other vaccines, provided they are given at different injection sites. Adverse reactions may be more pronounced, and immune response may be reduced in patients receiving immunosuppressive therapy. After vaccination, false-positive ELISA test results (for HIV-1, Hepatitis C, and especially HTLV-I) have been reported; however, Western Blot testing can differentiate these results. These temporary false positives may be due to IgM response induced by the vaccine.

Hypersensitivity to the active substance, any excipients, or residues such as eggs or chicken proteins (e.g., ovalbumin). The vaccine may also contain trace amounts of substances like kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB), and polysorbate 80. Vaccination should be postponed in individuals with fever or acute infection.

Available data from vaccination during pregnancy do not indicate harmful effects on the mother or fetus. The vaccine may be used from the second trimester onward. In pregnant women at higher risk of influenza complications, vaccination is recommended regardless of pregnancy stage. The vaccine can also be used during breastfeeding.

Antibody response may be reduced in patients with endogenous (disease-related) or iatrogenic (drug-induced) immunosuppression. As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following vaccination. Under no circumstances should the Inactivated Influenza Vaccine be administered intravascularly.

Vaccines, Anti-sera & Immunoglobulin

Store in a refrigerator at 2°C–8°C. Do not freeze. Keep the syringe in the outer carton to protect from light. Dispose of unused vaccine or waste materials according to local regulations.