Efluelda Tetra

/ Sanofi Israel Ltd

In adults 60 years of age and older: one dose of 0.7 ml.
Method of administration
The preferred route of administration for this vaccine is intramuscular although it may also be given subcutaneously.
The recommended site for intramuscular injection is the deltoid region. The vaccine should not be injected into the gluteal region, or into areas where there may be a major nerve trunk.

For adults 60 years of age and older, active immunisation is indicated for the prevention of influenza disease.

Hypersensitivity to the active substances or to any of the excipients

* Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.
* If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of any previous influenza vaccination, the decision to give Efluelda Tetra should be based on careful consideration of the potential benefits and risks.
* As with other vaccines administered intramuscularly, the vaccine should be administered with caution to subjects with thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
* Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
See prescribing information for full details.

Very common: injection site pain, injection site erythema, malaise, myalgia, headache.
Common: injection site swelling, injection site induration, injection site bruising,
Fever (≥37.5°C), shivering.
See prescribing information for full details.

* If injectable vaccines need to be administered at the same visit, immunisation should be carried out in separate limbs.
* The immunological response may be reduced if the patient is undergoing immunosuppressant treatment.
* 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 reported. An appropriate Western Blot test should be used to confirm or disprove the results of the ELISA test. The transient false positive reactions could be due to a non-specific IgM response induced by influenza vaccine.

This medical product has not been clinically evaluated in pregnant and breast-feeding women.
Pregnancy: Inactivated influenza standard dose vaccines (15 micrograms haemagglutinin of each virus strain per dose) 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. Data from worldwide use of inactivated influenza standard dose vaccines do not indicate any adverse foetal and maternal outcomes attributable to the vaccine. However, data on the use of influenza vaccines containing 60 micrograms haemagglutinin of each virus strain per dose in pregnant women are limited.
Lactation: This medical product may be used during breast-feeding. Based on experience with standard dose vaccines, no effects on the breast-fed infant are anticipated.

Cases of administration of more than the recommended dose have been reported with TIV- HD associated with inadvertent use in the population below 60 years of age due to medication error. When adverse reactions were reported, the information was consistent with the known safety profile of TIV-HD.