Abrysvo Special Precautions

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.
Hypersensitivity and anaphylaxis: Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Anxiety-related reactions: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection.
It is important that procedures are in place to avoid injury from fainting.
Concurrent illness: Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Thrombocytopenia and coagulation disorders: Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals.
Immunocompromised individuals: The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Abrysvo may be lower in immunosuppressed individuals.
Individuals less than 24 weeks of gestation: Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation. Since protection of the infant against RSV depends on transfer of maternal antibodies across the placenta, Abrysvo should be administered between weeks 24 and 36 of gestation (see Dosage & Administration and Pharmacology: Pharmacodynamics under Actions).
Limitations of vaccine effectiveness: As with any vaccine, a protective immune response may not be elicited after vaccination.
Excipient: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Abrysvo has no or negligible influence on the ability to drive and use machines.