Notice on reintroducing the batch of Glucose 10% Viaflo solution for infusion on the market
17.12.2014
Following to the Notice on temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate) of the marketing authorisation holder, Agmar d.o.o., published on 31 October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the reintroducing of the batch 14C17E3M of this medicine on the Croatian market.
The procedure of temporary suspension of distribution and use of this batch was initiated as a precaution measure, due to a suspected quality defect reported by a healthcare professional.
Based on the investigation results and special quality control, it is established that the tested samples comply with the approved specification regarding tested parameters. With regard to the quality control results, the temporary suspension of distribution and use of the batch 14C17E3M of this medicine is being abolished and the existing stocks may be used and dispensed again.
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.
