Remsima100 mg and 350 mg concentrate for solution for infusion, a new intravenous formulation of Remsima (infliximab) has been authorized.

This formulation contains sorbitol as an excipient and it is contraindicated in patients with hereditary fructose intolerance (HFI). In these patients, even small amounts of sorbitol administered intravenously can cause serious adverse reactions, including hypoglycaemia, acute liver failure, bleeding syndrome, renal failure, and death.

The previous sorbitol-free powder for infusion formulation remains available.

The product information and patient reminder card for Remsima have been updated to reflect the sorbitol content.

Healthcare professionals should verify the absence of HFI before administering this new formulation and provide patients with the updated reminder card.

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure ongoing monitoring of drug safety and the protection of patient health.