Problem Or Issue:
Following a review of the safety and efficacy of these products associated with the potential for development of antimicrobial resistance, the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded as follows:
The use of low doses of tiamulin for extended periods of time for metaphylaxis (when not associated with treatment) of swine dysentery caused by B. hyodysenteriae susceptible to tiamulin, was not proven to be effective and was considered to increase the risk for development of resistance, and was therefore no longer justified.
Actions To Be Taken:
This change relates to the indication for swine dysentery caused by B. hyodysenteriae susceptible to tiamulin only.
The use for swine dysentery caused by B. hyodysenteriae should be limited to the treatment and metaphylaxis (at the same time) at the dosage of 5 – 10 mg tiamulin hydrogen fumarate (equivalent to 4.05 – 8.1 mg tiamulin base) / kg bodyweight daily administered for 7 to 10 consecutive days.
The previous dosing recommendation of 2.0 mg tiamulin hydrogen fumarate for metaphylaxis of swine dysentery caused by B. hyodysenteriae has been removed and is no longer authorised.
The HPRA advises veterinary practitioners and users of these veterinary medicinal products to adhere to the conditions of the marketing authorisations as set out on the HPRA website (www.hpra.ie), pending the availability of new stock with updated labelling reflecting the change in the dosage regimen.
Any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form available at https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.