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 and the batch number of the administered product should be clearly recorded.

Prior to immunisation

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

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

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting.

Precautions for use

Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy.

As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals.

Systemic immunosuppressive medicinal products and immunodeficiency

Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals.
Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.

Excipients



This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7    Effects on ability to drive and use machines

No studies on the effects of Arexvy on the ability to drive and use machines have been performed.
Arexvy has a minor influence on the ability to drive and use machines. Some of the effects mentioned under section 4.8 “Undesirable effects” (e.g. fatigue) may temporarily affect the ability to drive or use machines.