Problem Or Issue:
Following consultation with the Veterinary Medicines Directorate in the UK and the Department of Agriculture, Food and the Marine, the HPRA has recently approved a variation to the terms of the marketing authorisation of the product Tuberculin PPD Kit (VPA10526/001/001 - Prionics Lelystad - B.V.).
The information in the Summary of Product Characteristics section 4.9 (and section 9 of the package leaflet) concerning the reading of the tuberculin test after injection, has been revised.
Previously the following advice was given:
“The presence of clinical signs, such as diffuse or extensive oedema, exudation, necrosis, pain at the site of test or swelling of the related pre-scapular lymph node, is always indicative of likely exposure to Mycobacterium species causing bovine tuberculosis. Animals showing such reactions must always be deemed as reactors, irrespective of the skin-fold measurements recorded.”
However, this advice has now been replaced with the following:
“The presence of clinical signs, 72 hours after injection of tuberculin PPD, such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the regional (pre-scapular) lymph nodes, is indicative of likely exposure to Mycobacterium species causing bovine tuberculosis (i.e., a member of the Mycobacterium tuberculosis complex). The person performing the test should carefully examine and record any such signs. Especially in case of necrosis in absence of any other clinical signs that are symptomatic of bovine tuberculosis, the tester should be cautious in making the correct interpretation. In case of doubt the competent authority may require additional diagnostic measures.”
Background Information Or Related Documents:
Following consultation with the Veterinary Medicines Directorate in the UK and the Department of Agriculture, Food and the Marine (DAFM) in Ireland, the HPRA has recently approved a variation to the terms of the marketing authorisation of the product Tuberculin PPD Kit (VPA10526/001/001 - Prionics Lelystad - B.V.).
The changes affect section 4.9 of the Summary of Product Characteristics (SPC) and the corresponding section 9 of the package leaflet and concern the reading of the tuberculin test after injection.
The updated version of the SPC is available for review on the HPRA’s website.
Actions To Be Taken:
Those veterinarians using Tuberculin PPD Kit (VPA10526/001/001 - Prionics Lelystad - B.V.) as part of Ireland’s Bovine TB Eradication Scheme should familiarise themselves with the changes that have been approved to the licence.
The HPRA advises users of this veterinary medicinal product to follow the conditions of the marketing authorisation as set out on the HPRA website (www.hpra.ie), pending the availability of new stock with an updated package leaflet reflecting the revised information.