Notice about temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)
GlaxoSmithKline d.o.o., marketing authorisation holder for Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), has upon request of the Agency for Medicinal Products and Medical Devices (HALMED) carried out a procedure of temporary distribution and use interruption of the batch AHBVC 262CD of this medicine.
The procedure of temporary distribution and use interruption of this batch of the medicine has been initiated as a caution measure, due to a suspected quality defect reported from a healthcare professional. The suspected quality defect consists in the change in appearance of the medicine (less milky than usual) and presence of precipitate particles that do not dissolve by remaining at the room temperature.
The existing stock of this medicine remains on the market until further, but they not should be dispensed or used. There are sufficient quantities of the batch AHBVC309AB of this medicine that is not affected by this quality defect and may be further delivered and used.
HALMED has requested sampling of this batch from the Ministry of Health and samples will be sent to HALMED for special quality control. The interruption of use of this batch will be in effect until the results of quality control and the conclusion of investigation have been obtained which 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.