Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion
14.11.2014
Fresenius Kabi d.o.o., the marketing authorisation holder for medicinal product Ciprofloxacin Kabi 400 mg/200 ml solution for infusion has upon request of the Agency for Medicinal Products and Medical devices (HALMED) initiated a procedure of temporary supply and use discontinuation of the batch 15HG229F1 of this medicinal product from the Croatian market.
The procedure of temporary supply and use discontinuation of this batch has been initiated due to a suspected quality defect discovered after healthcare professional reported on 12 and 13 November 2014 to HALMED five allergic adverse reactions ranging from mild redness, swelling and rash to thrombophlebitis and venous inflammation.
HALMED has informed the Ministry of Health to sample this batch and samples will be forwarded to HALMED for special quality control. The discontinuation of use of this batch will be in effect until the results of the special quality testing have been completed and the investigation on discovered quality defect concluded, which will be made publically available.
The existing stocks of this batch remain on the market, but may not be dispensed or used. All other batches of this medicine may be further supplied 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 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.
