Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection
09.05.2014
Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Esmeron 10 mg/ml solution for injection has started, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure for temporary interruption of the batch 557867 of this medicine from the Croatian market.
The procedure of temporary interruption of distribution and use of this batch of the medicine has been initiated due to a suspected quality defect, after HALMED received on 8 and 9 May 2014 from healthcare professionals six reports to allergic reactions, ranged from mild redness and rash to anaphylactic reaction.
The existing stock of this batch remain on the market, but must be neither dispensed nor used. All other batches of the medicine may be dispensed and used.
HALMED has requested from the Ministry of Health sampling of this batch and samples will be forwarded to HALMED for a special quality control. The interruption of use of this medicine will be in effect until the results of the special quality control and conclusions of the investigation of defects discovered have been made. The results of the investigation will be made publically available.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. 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 with their doctor or pharmacist about the continuation of their therapy.
