Bayer HealthCare’s Baytril® 100 Injectable Approved By FDA For Control Of BRD In High-Risk Cattle

Leading antimicrobial from Bayer HealthCare now approved for control of all four major BRD pathogens in high-risk cattle.

Cattle producers and veterinarians now have a new option for control of Bovine Respiratory Disease (BRD) in beef and non-lactating dairy cattle at high risk of developing BRD. Baytril® 100 (enrofloxacin) Injectable, manufactured by Bayer HealthCare LLC, Animal Health Division, has been approved by the Food and Drug Administration (FDA) for control of all four major BRD pathogens.
 
With the latest approval from FDA, Baytril 100 is the first and only fluoroquinolone approved for treatment of BRD and control of BRD in high-risk cattle, providing flexibility in treatment protocols. Cattle producers and veterinarians now can rely on Baytril 100 for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non‑lactating dairy cattle; and, for the control of BRD in beef and non-lactating dairy heifers less than 20 months of age at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.  
 
BRD has a significant health and economic impact on cattle operations across the country. Particularly susceptible are cattle at high risk of developing infections due to stress from travel and co-mingling with other cattle.

Specific high-risk factors for cattle can include:

  • Transportation with animals from two or more farm origins
  • Extended transport time with few to no rest stops
  • Environmental temperature changes of ≥30°F between locations, within a 24-hour period upon arrival
  • Exposure to wet or cold weather conditions
  • Excessive shrink (more than would be expected with normal load of cattle)
  • Stressful arrival processing procedures, such as castration or dehorning
  • Exposure within previous 72 hours to animals showing clinical signs of BRD

 
“Producers need options available when it comes to managing the welfare and health of their cattle,” said Dan Thomson, DVM, Ph.D., Beef Cattle Institute, Kansas State University. “With the approval of Baytril® 100 for control of BRD in high-risk cattle, there is greater flexibility for the management of BRD — whether it is a metaphylaxis or treatment scenario.”
 
In the lab, Baytril 100 kills 97 percent of the key BRD-causing bacteria in one to two hours1,2 in vitro.* In a clinical field study, Baytril 100 demonstrated statistically significant control of BRD in high-risk cattle in a 14-day study3.
 
“With the option of Baytril 100 as a control tool for BRD in high-risk cattle, producers and veterinarians can treat their cattle more efficiently to kill BRD and help the calf’s immune system get back to work,” said Todd Firkins, Livestock Category Manager, Food Animal Products, Bayer HealthCare Animal Health division.
 
Available in 100 mL, 250 mL and 500 mL bottles, Baytril 100 has been a choice for many bovine veterinarians and cattle producers since its introduction in 1998 and is the largest-selling, single-dose antibiotic in its class. The first FDA-approved fluoroquinolone antimicrobial for use against BRD, Baytril 100 is a proven and effective BRD antimicrobial.

For more information about Baytril 100, call Bayer Veterinary Services at
1-800-422-9874 or visit http://www.Baytril100.com.
 
*The clinical significance of in vitro data has not been demonstrated.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Extra-label use of this product in food-producing animals is prohibited. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
 
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. Find more information at http://www.bayerhealthcare.com.

Footnotes:
1. Blondeau J.M., Borsos S., Blondeau L.D., Blondeau B.J., Hesje C. The killing of clinical isolates of Mannheimia haemolytica (MH) by enrofloxacin (ENR) using minimum inhibitory and mutant prevention drug concentrations and over a range of bacterial inocula. In: ASM Conference on Pasteurellaceae; 2005 October 23-26; Kohala Coast, Big Island, Hawaii: American Society of Microbiology; 2005. Abstract B12.
2. Blondeau J.M., Borsos S.D., Hesje C.H., Blondeau L.D., Blondeau B.J. Comparative Killing of Bovine Isolates of Mannheimia haemolytica by Enrofloxacin, Florfenicol Tilmicosin and Tulathromycin Using the Measured Minimum Inhibitory Concentration (MIC) and Mutant Prevention Concentration (MPC) Drug Values. In: International Meeting of Emerging Diseases and Surveillance (IMED), Vienna, Austria, February 23-25, 2007. Figures 8-10.
3. Data on file.

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