Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.
Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia.
The procedure of discontinuation of distribution and use of these batches has been initiated over concern on a suspected quality defect based on an increased number of suspected adverse reactions to these medicines reported to HALMED in the last several weeks. The total number of reported suspected adverse reactions to HALMED concluding with the 26th May 2015 was 25 - mostly reactions on the application site. The reported adverse reactions were redness, oedema, pain and urticarial on the application site as well as thrombophlebitis and phlebitis on the administration site.
Based on the number of reported adverse reaction reports and available information, HALMED has requested from the marketing authorisation holder a temporary discontinuation of supply chain and distribution of the batches 15IB515P2 and 15 HL218F1 of Ciprofloxacin Kabi 400 mg/100 ml solution for infusion and batches 15IB515P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion. The existing stocks of these batches remain on the market but should not be distributed. All other batches may be further distributed and used.
HALMED has requested sampling of these batches by the Ministry of Health. Samples will be forwarded to HALMED for special quality control. The discontinuation of use of these batches will be in effect until the testing results have been obtained, which will be promptly made publically available.
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.