Question & Answer Guide

For Dairy Replacement HeifersBRD THERAPY

Q What is Baytril® 100 (enrofloxacin) Injectable?

Baytril 100 from Bayer HealthCare Animal Health is the first FDA-approved fluoroquinolone for the treatment of bovine respiratory disease (BRD). Studied in vitro* and field-tested repeatedly since its introduction, single-dose Baytril 100 still outsells every antibiotic in its chemistry class.1

A

What’s so important about BRD in dairy replacement heifers?

“ According to a recent USDA study, BRD is responsible for more than 20% of pre-weaned and 50% of post-weaned heifer deaths.” 2

— Dr. Sheila McGuirk, DVM

By the time your heifers start showing signs of BRD, it’s probably already done a lot of damage. BRD can start as early as 2–3 weeks of age in dairy replacement heifers and may go undetected. Left untreated, lung damage from BRD can be permanent. Catching the problem quickly is a key factor in treating BRD successfully.

QA

Do not use in female dairy cattle 20 months of age or older. Use of enrofloxacin in this class of cattle may cause milk residues.

Why is Baytril® 100 (enrofloxacin) Injectable so important to the dairy replacement heifer market?

Consider this: The cost of replacement heifers is

second only to feed costs in most dairy operations and

has increased considerably in the last few years.

But dairy replacement heifers are not just a financial

investment: they represent the future of your operation.

Risking them to BRD just isn’t an option.

By treating BRD, Baytril 100 can help save the lives

of valuable dairy replacement heifers, as well as

producers’ investments.

How does Baytril 100 kill bacteria?

Baytril 100 is bactericidal. Its mode of action kills the

control center of BRD-causing bacteria. DNA controls all bacterial cell activities. Enrofloxacin, the active

ingredient in Baytril 100, penetrates the bacteria

cell, inhibits the DNA gyrase and kills BRD-causing

bacteria in both the resting and growth phases

of bacterial development.3,4

In addition, Baytril 100 is concentration-dependent.

In vitro,* Baytril 100 kills 97% of BRD-causing bacteria

in 1–2 hours.5,6

In cattle, Baytril 100 delivers therapeutic drug

concentrations to the site of infection in the lung within

1–2 hours, and peak killing concentrations in less than

5 hours.*7

QA

QA

Cattle intended for human consumption must not be slaughtered within 28 days from last treatment. A withdrawal period has not been

established for this product in pre-ruminating animals.

*The clinical significance of in vitro data has not been demonstrated.

Q What were the steps Bayer took to get FDA approval for Baytril® 100 (enrofl oxacin) Injectable in the dairy replacement heifer market?

Bayer HealthCare Animal Health worked closely with university researchers to conduct an extensive qualitative and quantitative Risk Assessment to determine the potential impact on food safety and human health as a result of use in dairy replacement heifers. The FDA Center for Veterinary Medicine evaluated the Risk Assessment as part of the approval process.

Bayer is proud of the safety and performance legacy of Baytril 100, which has been proven among the millions of animals1 treated in the U.S. over the past decade.

A

Q What is a Risk Assessment?

A Risk Assessment is a qualitative and/or quantitative assessment of risk factors that could potentially impact human health. Typically, Risk Assessments take into consideration available data to evaluate and quantify the potential risk associated with the use of a product. During a Risk Assessment, wide margins of safety are utilized when existing data are not available.

A

Extra-label use of this product in food-producing animals is prohibited.

What was the purpose and the result of the Risk Assessment?

A Risk Assessment indicates risk estimates to public health.According to the Risk Assessment, use of Baytril® 100 (enrofl oxacin) Injectable in dairy heifers results in a near zero risk of additional human illness as indicated below.

Risk Estimates: One additional human case of campylobacter enteritis every 18 years • Risk of 1 case of persistent symptoms in 3.8 billion One additional human case of salmonella enteritis every 501 years • Risk of 1 case of persistent symptoms in 105 billion One additional human case of MDR salmonella enteritis every 292 years • Risk of 1 case of persistent symptoms in 61 billion

During the Risk Assessment, many conservative assumptions and worst-case assumptions of safety were utilized when existing data were not available, giving the Risk Assessment a large margin of safety.

The safety of Baytril 100 is well documented. The product has been approved by the FDA for use in dairy replacement heifers under 20 months of age as a BRD therapy.

Q Can Baytril 100 be used in lactating cows?

No. Baytril 100 cannot be used in lactating dairy cows. The additional FDA-approved label use of Baytril 100 is for the treatment of BRD in dairy heifers under 20 months of age. A

Q What is Bayer doing to support the proper use of Baytril 100?

Bayer HealthCare Animal Health strongly encourages veterinarians and producers to familiarize themselves with and follow responsible antibiotic use guidelines. Antibiotics are lifesaving tools and are not a substitute for proper animal husbandry. Prudent use of antibiotics is benefi cial for treated animals, public health, and producers’ and veterinarians’ businesses.

ADo not use in calves to be processed for veal.

1 Data on fi le.2 Dairy 2007 Part I: Reference of dairy cattle health and management practices in the United States, 2007. USDA website. Available at: http://www.aphis.usda.gov/ animal_health/nahms/dairy/downloads/dairy07/Dairy07_dr_PartI.pdf. Accessed February 10, 2015.3 Claus GW. Microbial nutrition, metabolism and growth. In: Carter GR, Chengappa MM, Roberts AW, eds. (1995). Essentials of Veterinary Microbiology. 5th ed. Philadelphia, PA: Williams & Wilkins; 39.4 Wetzstein H, deJong A. (1996). In vitro bactericidal activity and PAE of fl uoroquinolones used in veterinary medicine. In: Proceedings. 2nd International Veterinary Symposium on Baytril®. Compend Contin Educ Pract Vet. 18(2):22-29.5 Blondeau JM, Borsos S, Blondeau LD, et al. (2005). The killing of clinical isolates of Mannheimia haemolytica (MH) by enrofl oxacin (ENR) using minimum inhibitory and mutant prevention drug concentrations and over a range of bacterial inocula. In: ASM Conference on Pasteurellaceae; 23-26 October 2005; Kohala Coast, Big Island, HI: American Society of Microbiology; Abstract B12.6 Blondeau JM, Borsos SD, Hesje CH, et al. (2007). Comparative killing of bovine isolates of Mannheimia haemolytica by enrofl oxacin, fl orfenicol, 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 8-10.7 Davis JL, Foster DM, Papich MG. (2007). Pharmacokinetics and tissue distribution of enrofl oxacin and its active metabolite ciprofl oxacin in calves. J Vet Pharmacol Ther. 30(06):564-571.

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