Indications

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

Composition

• 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.

Pharmacology

Dosage & Administration

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.

Contraindications

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.

Side Effects

Pregnancy & Lactation

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.

Precautions & Warnings

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. Inactivated Influenza Vaccine should under no circumstances be administered intravascularly.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin

Storage Conditions

Inactivated Influenza Vaccine 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.