Notice on re-marketing of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)
23.02.2015
Further to the Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan), published on 18 July 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about re-marketing of the said batch.
The procedure of temporary interruption of distribution and use of the said batch was launched as a precautionary measure due to a suspected quality defect report on the discovered turbid solution received by healthcare professionals.
Since based on the investigation the quality defect has not been confirmed, the temporary interruption of distribution and use of the batch HC 68E of this medicine has been revoked, and the existing stock can be dispensed and used again.
In addition, we remind healthcare professionals of the alert specified in the approved patient information leaflet: "The doctor/healthcare personnel will not apply you Campto in case the sediment in the bottle or dilute solution is found. In this case the healthcare personnel should dispose an unused medicine solution in accordance with applicable regulations regarding the disposal of cytotoxic medicine."
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
