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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 have been reported following Beyfortus administration. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reaction 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 Pharmacology: Pharmacokinetics under Actions), and nirsevimab may not provide the same level of protection in those individuals.
Polysorbate 80: This medicine contains 0.1 mg of polysorbate 80 in each 50 mg (0.5 mL) dose and 0.2 mg in each 100 mg (1 mL) dose. Polysorbates may cause allergic reactions.
Effects on ability to drive and use machines: Not applicable.
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