Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefixime) reintroduced into the market
06.10.2014
Following to the Information on temporary recall of Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefiximum) released on 30 April 2014. the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about the reintroducing of this medicinal product with the modified syringe.
The procedure of temporary recall of this medicinal product was initiated due to an unclear graduation of the attached syringe that was graduated in kg of body mass instead in ml of prepared solution, which might have led to a medication error when administering the medicine. The risk was primarily related to sub-dosing where only a half of the foreseen dose would have been used when the medicine is to be administered once daily. This incorrect dosing would have represented a risk of insufficient therapeutic efficacy of the medicine. The recall was carried out to the pharmacy level.
The manufacturer, Jadran Galenski laboratorij d.d., has attached a syringe graduated in ml pf prepared solution, labelled the medicine in compliance with the variation in the documentation for granting the marketing authorisation and released again the product on the 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.
