Distribution, Manufacturing and Inspection

Notice on temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate)


Agmar d.o.o., the marketing authorisation holder for Glucose 10% Viaflo solution for infusion (glucose hydrate), is carrying out, at the Agency’s request , the recall procedure of the batch 14C17E3M of this medicine.

The recall procedure of Glucose 10% Viaflo solution for infusion of the batch 14C17E3M is being carried out based on the reported quality defect from healthcare professional on discovered damage on the inner package (bag) that led to a leaking on the sealed bag site.

The batch 14C17E3M is currently the only one batch that the marketing authorisation holder disposes of. HALMED asked the Ministry of Health to sample this batch and samples will be forwarded to HALMED for quality control. The disruption of use of this medicine will be in effect until the results of quality control have been completed and the investigation on quality defect concluded, which will be made publically available.

There are other medicinal products with the same pharmaceutical form and active substance on the Croatian market.

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.