Fluarix Tetra

/ GSK

Adults: 0.5 ml
Paediatric population: Children from 36 months onwards: 0.5 ml. For children aged < 9 years, who have not previously been vaccinated against influenza, a second dose should be given after an interval of at least 4 weeks. Children less than 3 years: the safety and efficacy of this vaccine in children less than 3 years have not been established.
Method of administration: Immunisation should be carried out by intramuscular injection. Precautions to be taken before handling or administering the medicinal product.
For instructions for preparation of the medicinal product before administration- See prescribing information for full details.

Active immunization of adults and children from 3 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. Should be based on official recommendations. Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus might change from year to year.

Hypersensitivity to the active substances or to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate. Immunisation should be postponed in patients with febrile illness or acute infection.

It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. This vaccine  is not effective against all possible strains of influenza virus, it’s intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees. This vaccine  should under no circumstances be administered intravascularly. As with other vaccines administered intramuscularly, should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Local injecton site pain, headache, fatigue, myalgia, irritability.
See prescribing information for full details.

No interaction studies have been performed. This vaccine  is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.

Pregnancy: Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of inactivated influenza vaccines do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
Lactation: This vaccine may be used during breast-feeding.       

Overdosage is unlikely to have any untoward effect.

Storage: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect from light.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.