Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Efluelda should under no circumstances be administered intravascularly.

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 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.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

As with any vaccine, a protective response may not be elicited in all vaccine recipients.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.


Effects on Driving

4.7     Effects on ability to drive and use machines
Efluelda has no or negligible influence on the ability to drive and use machines.