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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.
Cardiovascular risk: Patients with a history of cardiovascular disease (e.g. hypertension, ischemic heart disease) were excluded from clinical studies (see Pharmacology: Pharmacodynamics under Actions). No safety data are available in these patients.
Serious hypersensitivity: Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Most hypersensitivity reactions occurred during infusion and were not serious (see Adverse Reactions). If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated.
Effects on ability to drive and use machines: VYEPTI is expected to have no or negligible influence on the ability to drive and use machines.
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