In January 2021, the FDA’s Center for Veterinary Medicine, as well as the Veterinary Drugs Directorate of Health Canada, added Mycoplasma hyopneumoniae to the approved label indications for Aivlosin® (tylvalosin) Water Soluble Granules (WSG).
“This approval gives Aivlosin® WSG the broadest label indication of any product for the control of swine respiratory disease (SRD),” says Dr. Chad Smith, U.S. technical service veterinarian for Pharmgate. “M. hyo is a primary pathogen in swine respiratory disease complexes and plays an important role in facilitating the entry of bacterial and viral pathogens. Aivlosin® WSG is competitive economically compared to other protocols on a per-pig basis. Veterinarians and producers can be confident they are making a responsible antibiotic choice to control SRD.”
The new label indications for Aivlosin® WSG in the U.S. and Canada are as follows:
U.S.
Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE. Control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, Streptococcus suis and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD.
Canada
For the treatment of Porcine Proliferative Enteropathy (PPE) associated with Lawsonia intracellularis in pigs. As an aid in reducing the severity of Swine Respiratory Disease (SRD) associated with Haemophilus parasuis, Pasteurella multocida, Streptococcus suis and Mycoplasma hyopneumoniae in groups of pigs experiencing an outbreak of SRD.
Pharmgate offers Aivlosin® WSG in two package sizes: 160 grams and 400 grams. Administered in pigs’ drinking water for five days, it is rapidly absorbed, quickly achieves therapeutic levels and provides the assurance of a zero-day withdrawal period.
Use of the product requires a veterinary prescription. While the new claim approval is effective immediately, it may take some time before new packaging reflecting this approval is widely available in the market.
Complete label information is available at pharmgate.com.
February 1, 2021 - Pharmgate