The new indication adds to the product’s existing claims for the treatment of respiratory disease in both cattle and swine.
The approval was based on data from a multi-centric field trial which enrolled more than 360 sheep on farms in the EU to evaluate the efficacy and safety of a single subcutaneous dose of gamithromycin to treat footrot. Study sites in the UK were included. Merial says the study demonstrated a statistically superior reduction in lameness and a numerically higher reduction in foot lesions versus tilmicosin. On day 21, 97.8% of Zactran treated sheep were no longer lame, compared to 93.3% of the tilmicosin group.
Sioned Timothy, Technical Manager UK and Ireland said: "This is an exciting development in the treatment of footrot throughout the UK and Europe.
"Footrot is an extremely painful disease and is recognised to have a significant impact on welfare and productivity. It can cause rapid weight loss and reduce reproduction rates, significantly impacting sheep farm profitability. Zactran is a highly effective, fast-acting, single shot injectable treatment, and provides a valuable tool for vets and farmers to use when implementing footrot control strategies.
Findlay MacBean, Head of Large Animal Business UK & Ireland, said: "Our goal at Merial is to improve the health and productivity of production animals through innovative solutions. We hope that the addition of this new indication for Zactran does just that, and gives us the opportunity to bring a cost-effective and practical solution for footrot in sheep to the marketplace.
"It also demonstrates our continued commitment to the sheep market and our ongoing investment in this sector. At Merial we always promote best practice, and believe that the addition of this product extension to our portfolio will help farmers achieve better health status in their flocks and ultimately improve farm profitability."
Zactran is available in the EU as a 150 mg/ml solution presented in 50ml, 150ml and 250ml bottles.
For further product information, see the SPC here.
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