Information about temporary distribution and use disruption of the batch 37/I of the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection


Institute of Immunology, the marketing authorisation holder for the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection, has at request of the Agency for Medicinal Products and Medical Devices (HALMED) temporary interrupted the distribution and use of the batch 37/1 of this vaccine on the Croatian market.

The procedure of temporary interruption of distribution and use of this batch has been initiated due to suspected quality defect reported from healthcare professional. The report indicated that clumps of 1-3 mm exist that do not dissolve after long mixing. According to the Summary of Product Characteristics, the pharmaceutical form of the medicine is milky white to grey-yellowish suspension for injection. At standing of the solution, a grey-yellowish precipitation may occur that dissolves after shaking.

HALMED has requested sampling of this batch from the Ministry of Health, after which samples have been forwarded to special quality control by HALMED. The temporary disruption in distribution and use of this batch will be in effect by the end of investigation and analysis, which is expected next week.

There are sufficient quantities of the other on the Croatian market which is not affected by this suspected quality defect and that may be further distributed and used so that the vaccination program is not at risk.

Healthcare professionals should be reminded that when storing and administering the medicine, instructions in the summary of product characteristics should be followed. The vaccine should be stored in box to be protected from the light, at 2 to 8 °C. It should not be frozen because at lower temperatures changes it physical properties and may not be use any more. In addition, the vaccine should be kept in a good closed original container. When opening the a single dose container, the vaccine should be used immediately, whereas the vaccine in ten-dose vials may be used within 24 h after first opening by applying aseptic rules at handling.

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.