Influvax Tetra IM Injection

Prophylaxis of influenza (flu), especially in those who run an increased risk of associated complications. The use of Influvax Tetra should be based on official recommendations.

One dose (0.5 ml) contains Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilized hen’s eggs from healthy chicken flocks, and inactivated with formaldehyde, of 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 over 36 months of age: 0.5ml
• Children from 6 to 35 months of age: clinical data are limited. Doses of 0.25 ml or 0.5 ml have been used.

Administrations: For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection. Immunisation should be carried out by intramuscular or deep subcutaneous injection. The vaccine should be allowed to reach room temperature before use. Shake before use. Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Influvax Tetra may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified. The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. Following influenza vaccination, false positive results in serology tests using the ELISA method (blood test) to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA results. The transient false positive reactions could be due to the IgM response by the vaccine.

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80. Immunisation shall be postponed in patients with febrile illness or acute infection.

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Inactivated Influenza Vaccine may be used during lactation.

Antibody response in patients with endogenous (due to illness) or iatrogenic (due to medicine) immunosuppression (poor immune response) may be insufficient. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Influvax Tetra should under no circumstances be administered intravascularly.

Vaccines, Anti-sera & Immunoglobulin

Influvax Tetra must be stored in a refrigerator (2°C-8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.