Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39

Meropenem 1000 mg powder and solvent for solution for infusion

SNOMED code: 44947011000001108 (24 pack)

B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion. The PIL provides incorrect information regarding the sodium content and product strength in the sections outlined below. Currently all available stock contains the affected version of the PIL.

To minimise the risk of supply disruption, certain batches that have not yet been distributed are also included in this notification. Following discussions between the MHRA and the Department of Health and Social Care, these products have been considered critical for patients. Therefore, the affected batches will continue to be supplied without repackaging and are included in this notification.

In section 2 the sodium content was reflected incorrectly:

In the section 6 the strength of the product was stated incorrectly:

All information on the Label and in the SmPC is correct and all other sections in the PIL are also correct.

Healthcare professionals are advised to continue using B. Braun Meropenem 1000 mg powder and solvent for solution for infusion in accordance with the approved Summary of Product Characteristics (SmPC). Although section 6 of the Patient Information Leaflet (PIL) incorrectly refers to 500 mg, the correct strength (1000 mg) is stated on the product packaging and in the relevant PIL heading.

The identified issue is limited to incorrect information within sections 2 and 6 of the PIL, relating to the stated sodium content and product strength respectively. The issue does not affect the quality of the physical product formulation or efficacy of the medicinal product.