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.

Hypersensitivity including anaphylaxis

Serious hypersensitivity reactions, including anaphylaxis, have been observed with monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.

Clinically significant bleeding disorders

As with any other intramuscular injections, nirsevimab should be given with caution to individuals with thrombocytopenia or any coagulation disorder.

Immunocompromised children

In some immunocompromised children with protein-losing conditions, a high clearance of nirsevimab has been observed in clinical trials (see section 5.2), and nirsevimab may not provide the same level of protection in those individuals.

Effects on Driving

4.7   Effects on ability to drive and use machines

Not applicable.