Remsima contains polysorbate 80

This medicine contains 0.5 mg of polysorbate 80 in each pre-filled pen which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Updates to SmPC as follows:

In Section 2, additional text:

Excipient(s) with known effect

This medicine contains 45 mg sorbitol (E420) and 0.5 mg polysorbate 80 (E433) in each mL of solution.

In Section 4.4, additional text:

Polysorbate 80

This medicine contains 0.5 mg of polysorbate 80 in each pre-filled syringe/pre-filled pen which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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