Notice on reinstatement of batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batch 15IB515P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion
20.10.2015
Following to the Notice on temporary discontinuation of distribution and use of the batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and the batches 15IB515P2 and Ciprofloxacin Kabi 200 mg/100 ml solution for infusion, released on 26th May 2015, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform on the reinstatement of these batches on the market.
The temporary discontinuation procedure distribution of these batches has been initiated as precaution measure, due to a suspected quality defect based on an increased number of reports to suspected adverse reactions, received by HALMED to these medicines.
Based on the investigation of the manufacturer and results of the special quality control conducted at the HALMED’s Official Medicines Control Laboratory (OMCL), no quality defect has been confirmed, therefore, the temporary discontinuation of distribution and use of the batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB515P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion and the existing stocks may be distributed and used.
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, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
