Baytril®100 (enrofloxacin) 100 (enrofloxacin) 100 Injectable

Your first-line therapy for treating BRD and reducing the bacteria

load upfront.load upfront.

Make single-dose Baytril® 100 (enrofloxacin) Injectable your first-line therapy for BRD.

FDA-approved for both treatment of BRD and control (metaphylaxis) of BRD in high-risk cattle.

Whether controlling or treating bovine respiratory disease (BRD), it’s important to kill bacteria to let the calf’s immune system get back to work. Use Baytril 100 first to reduce the bacteria load in high-risk cattle right off the truck.

• Baytril 100 is effective with a single dose for control and treatment usage.

• Baytril 100 outsells every antibiotic in its class.1

• Baytril 100 is bactericidal, and kills all four of the major BRD-causing pathogens:

– Mannheimia haemolytica – Pasteurella multocida – Histophilus somni – Mycoplasma bovis

• In vitro*, Baytril 100 kills 97% of key BRD-causing bacteria in 1–2 hours.2,3

• Baytril 100 delivers therapeutic drug concentrations to the site of infection in the lungs in 1–2 hours.4

*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.

Baytril 100 was put to the test in a 14-day study at six different locations. At each of the study sites, high-risk cattle injected with Baytril 100 were constantly exposed to BRD-causing bacteria from other cattle to increase BRD pressure.

At the end of the study, findings from the Baytril 100 cattle showed:

• Baytril 100 achieved a 33.7% reduction in BRD versus the non-Baytril 100 group5

• This result was statistically significant (P = 0.0012)5

Plus, clinical signs of depression and respiratory distress from BRD were comparatively reduced in the cattle that received Baytril 100.

A different dose for BRD control and treatment.Although the 3.4–5.7 mL/cwt (7.5–12.5 mg/kg) dose is approved for treatment, the 5–5.5 mL/cwthas settled out to be the most recommendedtreatment dose by veterinarians. However, the approved dose for control of BRD in high-risk calves is 3.4 mL/cwt (7.5 mg/kg) and has been demonstrated as effective in reducing morbidity when used for metaphylaxis in a 14-day study.5

Once bacteria are dead, they’re dead.When it comes to BRD, time is of the essence. It’s not about how long a drug stays “on board” the cattle’s system, but how effectively the drug works to eradicate the bacteria that cause BRD.

Ask your veterinarian about using Baytril 100 as your go-to drugfor control of BRD in high-risk cattle or treatment of BRD.

Baytril® 100 (enrofloxacin) Injectable demonstrated statistically significant control of BRD in high-risk cattle in a 14-day study.5

Extra-label use in food-producing animals is prohibited.

Stressors, viruses and infectious bacteria can result in BRD.Watch for the signs of sickness.

Are your cattle at risk?

Stressors such as weaning, shipping, processing, ration change, overcrowding, commingling and adverse weather compromise a calf’s immune system. A variety of viruses (IBR, BVD, BRSV and PI3) can invade and damage the calf’s respiratory tract, which compromises its natural defense mechanisms, including the ability to expel bacteria and dust from the lungs. This damage, along with a suppressed immune system, permits the invasion of BRD-causing bacteria such as Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis.

When a calf develops BRD, it typically occurs within a few days following exposure. Sick calves usually demonstrate some or all of the following clinical signs:

• Depression • Drooping ears • Extended head and bowed back • Isolation from other cattle • Lack of appetite

Consult with your veterinarian to see if conditions exist that may indicate your calves being at high risk of contracting BRD. Some conditions may include:

• Transportation with animals from two or more farm origins • An extended transport time with few to no rest stops • An environmental temperature change of ≥30°F during transportation • A ≥30°F range in temperature fluctuation within a 24-hour period • Exposure to wet or cold weather conditions • Excessive shrink (more than would be expected with a normal load of cattle) • Stressful arrival processing procedures (e.g., castration or dehorning) • Exposure within the prior 72 hours to animals showing clinical signs of BRD

• Dull, sunken eyes • Nasal/ocular discharge • Loose feces • Rapid breathing and coughing • Elevated temperature (≥104°F)

Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. Do not use in calves to be processed for veal.

The sooner cattle feel better, the faster they get back to work eating.Baytril® 100 (enrofloxacin) Injectable is backed by a history of success.

The first FDA-approved fluoroquinolone for the treatment of BRD, Baytril 100 has been proven through 16 years of use and repeated field-testing. Today, single-dose Baytril 100 remains a leading antibiotic.1

• More than 45 million doses sold1 — and counting.

• Field studies indicate efficacy against the four major BRD pathogens.

• No suppression of appetite has been associated with Baytril 100 when used according to the label.

• Approved for treatment of non-lactating dairy replacement heifers less than 20 months of age.

Plus, Baytril 100 is approved for the single-dose treatment of Mycoplasma bovis. That means Baytril 100 can be used to treat all four major BRD pathogens with a single dose.

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. Do not use in calves to be processed for veal.

Both in vitro* and in vitro* and in vitro in vivo data in vivo data in vivodemonstrate the bacteria-killing qualities of Baytril® 100 (enrofloxacin) Injectable.

Baytril 100 is bactericidal. Its unique mode of action kills the control center of BRD-causing bacteria.

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

A withdrawal period has not been established for this product in pre-ruminating calves.

kills the control center of BRD-causing bacteria.

DNA controls all bacterial cell activities, including metabolism, protein synthesis, cell maintenance and energy production. Enrofloxacin, the active ingredient in Baytril 100, penetrates the bacteria cell, inhibits the DNA gyrase and kills BRD-causing bacteria.

• Baytril 100 is broad-spectrum, killing the four major BRD-causing bacteria.

• Baytril 100 kills bacteria in both its resting and growth phases of bacterial development.6,7

• Baytril 100 has an active metabolite with equal or higher in vitro* potency than the parent molecule.8

Baytril 100 is concentration-dependent.*Bactericidal killing studies were performed in the laboratory to evaluate how Baytril 100 kills bacteria. These in vitro* studies indicated that the higher the concentration of Baytril 100, the faster it kills.2,3,9

Baytril 100 concentrations minimize the selection for bacteria resistance.

Studies completed in the laboratory evaluate how Baytril 100 kills bacteria.

• Baytril 100 reaches MPC (mutant prevention concentrations) to Mannheimia haemolytica in blood plasma in 40 minutes and in pleural interstitial fluid in just over 6 hours.*2,4

• Baytril 100 blood levels remain above MPC to kill susceptible and mutant Mannheimia haemolytica bacteria for 18 hours.*2,4

0 24 48 72 Time (hours)

Drug Level

Num

ber o

f Bac

teria

MIC90

Drug LevelBacterial Population

Time-Dependent(Concept Illustration)

Cell: Penicillins Cephalosporins Excede® Naxcel®

DNA: Fluoroquinolones Baytril 100 Advocin®

Major Antibacterials: Modes of Action

Ribosomes: Tetracyclines

Bio-Mycin® 200 Fenicols Nuflor® Nuflor Gold® Resflor Gold®

Macrolides Micotil® 300 Draxxin® Zactran® Zuprevo®

Bacterial Cell

Concentration-Dependent(Concept Illustration)

0 24 48 72 Time (hours)

Drug LevelBacterial Population

Drug Level

Num

ber o

f Bac

teria

MIC90

Baytril 100 has a classic concentration-dependent profile.

Hours Post-SubQ Injection

2.0

1.8

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

00 2 4 6 8 10 12 14 16 18 20 22 24

MPC 90*3

Drug

Plas

ma C

once

ntra

tion (

µg/m

L)

M. haemolytica

MIC90 = 0.125 µg/mL*10

Pharmacokinetics: 12.5 mg/kg

enrofloxacin with active metabolite10

• Baytril 100 reaches peak killing concentration in less than 5 hours in the lungs.*4

• High bio-availability maximizes enrofloxacin’s ability to get to the site of infection.

• Highly lipophilic, enrofloxacin leaves the blood and penetrates tissue.

• Baytril 100 has been shown to reach similar drug levels in both diseased and healthy lungs.11

Baytril 100 helps cattle feel better and get back to the bunk.

The sooner bacteria are killed, the faster a calf will feel better and get back to work eating.

• In vitro*, Baytril 100 kills 97 percent of BRD-causing bacteria in 1–2 hours.2,3

• In field trials, significant improvements in temperature and attitude scores were noted within 24 hours of treatment.12

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.

Baytril® 100 (enrofloxacin) Injectable is field-proven in millions of cattle.1

Baytril 100 reaches therapeutic levels at the site of infection in the lungs within 1–2 hours.*infection in the lungs within 1–2 hours.*44

Bactericidal Bacteriostatic

Baytril 100 (enrofloxacin)

Advocin™ (danofloxacin mesylate)

Nuflor® and Nuflor Gold® (florfenicol)**

Resflor Gold® (florfenicol and flunixin meglumine)

Excede® (ceftiofur crystalline-free acid)

Excenel® RTU (ceftiofur hydrochloride)

Naxcel® (ceftiofur sodium)

Penicillin

Draxxin® (tulathromycin)

Micotil® (tilmicosin)

Zactran® (gamithromycin)

Zuprevo® (tildipirosin)

Nuflor (florfenicol)**

Bio-Mycin® 200 (oxytetracycline)

Liquamycin® LA-200® (oxytetracycline) LA-200® (oxytetracycline)

Time-

Depe

nden

tCo

ncen

tratio

n-De

pend

ent

Product Mode of Action Chart

**Nuflor has been reported to show bactericidal claims against certain bacterial strains (see Nuflor label for additional information).

2.0

1.6

1.2

0.8

0.4

Concentration in Lung Tissue (7.5 mg/kg)11

µg/m

L or g

m

Lung healthy (Lh) Lung diseased (Ld)

8 24

Hours Post-Administration

Time-Kill-Kinetics in M. haemolytica*9

Num

ber o

f Bac

teria

(CFU

/ mL)

0 4 8 12 16 20 24 Time (hours)

109

108

107

106

105

104

103

102

101

100

Mannheimia haemolytica

controlenrofloxacin 0.125 µg/mL

(MIC = 0.06 µg/mL)

107.0

106.0

105.0

104.0

103.0

102.0

101.01 2 3 4 5 6 7 8 9 10

Day

Tem

pera

ture

(F)

Baytril 100Control

Study Report 74653-Appendix 212

Temperature Reduction

Tem

pera

ture

(°F)

Day

Baytril 100

Control

107.0

106.0

105.0

104.0

103.0

102.0

101.01 2 3 4 5 6 7 8 9 10

Single-dose Baytril® 100 (enrofloxacin) Injectable delivers reliable and cost-effective antibacterial control of BRD

in high-risk cattle and treatment of BRD.

• Control dose is 30–40% smaller in size and cost than the most common treatment dose.

• Convenient, single-dose therapy reduces time and labor costs.

• Single-dose therapy reduces animal handling, which reduces stress on sick cattle.

• Baytril 100 is easy to syringe, even in cold weather.13

Baytril 100 Dose and Treatment Schedule‡

Based on research conducted to date, we believe 12.5 mg/kg to be the most appropriate dosing rate for treatment.

‡Dose volumes have been rounded to the nearest 0.5 mL within the dose range.

CattleWeight (Ib)

100

200

300

400

500

600

700

800

900

1,000

1,100

WithdrawalTime

TREATMENT:Single-Dose

Therapy12.5 mg/kg

Dose Size (mL)

5.5

11.0

17.0

22.5

28.5

34.0

39.5

45.5

51.0

57.0

62.5

28 Days

CONTROL:Single-Dose

Therapy7.5 mg/kg

Dose Size (mL)

3.5

7.0

10.5

14.0

17.0

20.5

24.0

27.5

31.0

34.0

37.5

28 Days

Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

MIC Susceptibility Values For Enrofloxacin

†The MIC for 50% and 90% of the isolates.

MIC90†

µg/mL

0.03

0.5

0.06

0.03

Pathogen

Histophilus somni

Mycoplasma spp.

Mannheimia haemolytica

Pasteurella multocida

Number ofIsolates

104

124

121

108

MIC50†

µg/mL

0.015

0.25

0.06

0.015

In clinical studies, Baytril® 100 (enrofloxacin) Injectable delivered fewer mortalities than some other cattle antibiotics.14,15

To help you understand and use our product better, Bayer commits a sizeable investment of time and money to field trial comparison studies. The trend emerging from multiple studies demonstrates that Baytril 100 results in fewer fatalities.

• Baytril 100 is backed by Bayer, a leading-edge animal health company committed to the veterinary and cattle industries.

• Bayer is committed to high industry standards for injectable animal health products and the production of quality meat and dairy products.

• Use Baytril 100 with confidence — veterinarians have successfully used enrofloxacin worldwide for more than 20 years.

• Baytril 100 has been shown to be safe in beef cattle of all ages and in dairy heifers less than 20 months of age.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Competition Baytril 100

Comparison of Case Fatality in Field Trials

18%a

11%b

Nuflo

r

1%d

11%c

Mico

til

Study 08–99 (P=0.013)15Study 151.678 (P= 0.02)14

201816141210

8642

CFR

(%)

Different superscripts represent statistically different values.

©2015 Bayer HealthCare LLC, Animal Health, Shawnee Mission, Kansas 66201Bayer, the Bayer Cross, Baytril and Right the first time are registered trademarks of Bayer.

Bio-Mycin is a registered trademark of Boehringer Ingelheim Vetmedica, Inc. Advocin, Draxxin, Excede, Excenel, Liquamycin, LA-200 and Naxcel are registered trademarks of Zoetis.Nuflor, Nuflor Gold, Resflor Gold and Zuprevo are registered trademarks of Intervet, Inc. Micotil is a registered trademark of Eli Lilly and Company. Zactran is a registered trademark of Merial Limited.

©2015 Bayer HealthCare LLC, Animal Health, Shawnee Mission, Kansas 66201Bayer, the Bayer Cross, Baytril and Right the first time are registered trademarks of Bayer.

1 Data on file. 2 Blondeau JM, Borsos S, Blondeau LD, Blondeau, et al. (2005). 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; 23-26 October 2005; Kohala Coast, Big Island, Hawaii: American Society of Microbiology; Abstract B12. 3 Blondeau JM, Borsos SD, Hesje CH, et al. 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: International Society for Infectious Diseases. February 23-25, 2007. Figures 8-10. 4 Davis JL, Foster DM, Papich MG (2007). Pharmacokinetics and tissue distribution of enrofloxacin and its active metabolite ciprofloxacin in calves. J Vet Pharmacol Ther. 30(6):564-571. 5 Data on file. 6 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. 7 Wetzstein H-G, deJong A. (1996). In vitro bactericidal activity and PAE of fluoroquinolones used in veterinary medicine. In: Ford R, ed., Second International Veterinary Symposium on Baytril® Proceedings. Compend Contin Educ Pract Vet. 18(2):22-29. 8 Grobbel M, Lübke-Becker A, Wieler LH, et al. (2007). Comparative quantification of the in vitro activity of veterinary fluoroquinolones. Vet Microbiol. 124(1–2):73–81. 9 Concentration-dependent Killing Activity of Baytril® 100 (enrofloxacin). Bayer Study, BL04195 (Pirro et al., BCVA Autumn Meeting, Glasgow, October 2000). 10 Data on file. 11 Data on file. 12 Freedom of Information Summary for Baytril® 100 (enrofloxacin) Injectable, NADA: 141-068. 13 Data on file. 14 Data on file.15 Data on file.

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