EU Product Information (PI) update for alignment with reference product.

Package leaflet section 4

Not known:

(…)

• Infection due to a live vaccine because of a weakened immune system.
• Problems following a medical procedure (including infectious and non-infectious problems).

EU Product Information (PI) update for alignment with reference product.

SmPC Section 4.4 - Others

There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty. The long half life of infliximab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on infliximab should be closely monitored for infectiousns and non-infectious complications, and appropriate actions should be taken (see section 4.8).

New SmPC for medicines.ie