Discover the. Discover the. innovative science. Veraflox (pradofloxacin) Veraflox. Efficacy. Safety. Ease-of-use.

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1 Discover the Discover the innovative science. science of Veraflox Oral Veraflox. Suspension for Cats Efficacy. Safety. Ease-of-use. An unprecedented combination of efficacy, safety and ease-of-use. Designed specifically for the needs of cats.

2 Veraflox is the next step in veterinary antibiotic therapy for cats. Veraflox delivers Efficacy. Pradofloxacin The unique molecular structure of pradofloxacin was specifically engineered with high-affinity dual targeting to offer a broadened spectrum of bactericidal activity compared to previous generation fluoroquinolones. 1,2 Safety. Veraflox is tested and approved for use in kittens and cats 12 weeks of age and older. 3 The ocular safety of Veraflox was thoroughly tested using the most advanced methods. 3 Ease-of-use. To help make Veraflox convenient and easy to administer which may help increase owner compliance it comes in a flavored, well-accepted, once-daily oral suspension with a user-friendly, low-mess dispenser. 4,5 Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra label use of this drug in food-producing animals. For use in cats only.

3 See the next-generation veterinary antibiotic. Veraflox was designed to improve upon the efficacy against Gram-positive and anaerobic pathogens versus previous generation fluoroquinolones while delivering the same Gramnegative activity.* 6 Veraflox delivers enhanced bactericidal activity by attacking both of the essential target enzymes necessary for bacterial DNA replication DNA gyrase and topoisomerase IV with high affinity.* 2 Dual Molecular Targeting* 2 In in vitro studies, pradofloxacin demonstrated simultaneous high-activity inhibition of two important bacterial target enzymes. This feature: High dual binding affinity blocks DNA replication Pradofloxacin Topoisomerase IV DNA gyrase Provides a high rate and extent of in vitro bactericidal activity against target pathogens May reduce the probability of selecting resistant bacterial strains Pradofloxacin exhibits clear bactericidal activity in terms of MBC [minimum bactericidal concentration] and kill kinetics Silley, et al., 2011 Enhanced Spectrum of Veraflox* aerobes Veraflox is bactericidal, with activity against Gram-negative, Gram-positive, and anaerobic bacteria. Gram + Gram - *The clinical significance of in vitro data has not been demonstrated. anaerobes Quinolone-class drugs have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Pradofloxacin is contraindicated in cats with a known hypersensitivity to quinolones.

4 Veraflox in perspective. Veraflox is approved for the treatment of skin infections (wounds and abscesses) in cats. Pradofloxacin has favorable pharmacokinetics and demonstrates low MICs for many target pathogens. 7 Cmax/MIC ratios in cats 30 Cmax (total drug)/mic90 Ratios 3,8,9 Label comparison Staphylococcus aureus Pradofloxacin oral suspension 7.5 mg/kg Marbofloxacin tablets 5.5 mg/kg Orbifloxacin oral suspension 7.5 mg/kg 30 Cmax (free drug)/mic90 Ratios 3,8,9 Label comparison Staphylococcus aureus Pradofloxacin oral suspension 7.5 mg/kg DATA NOT AVAILABLE Marbofloxacin tablets 5.5 mg/kg 6.3 Orbifloxacin oral suspension 7.5 mg/kg General pharmacodynamic principles ascribe antimicrobial efficacy to Cmax/MIC90 ratios > 8 10 for concentration-dependent drugs (e.g., fluoroquinolones) 10 Veraflox is labeled for use against Streptococcus canis a pathogen against which most previous fluoroquinolones have shown poor activity. 11 Not for human use. Keep out of reach of children. The administration of pradofloxacin for longer than 7 days induced reversible leukocyte, neutrophil and lymphocyte decreases in healthy, 12-week-old kittens.

5 A look at safety. The safety of Veraflox has been demonstrated in extensive safety and clinical trials. Veraflox was found to be safe in kittens as young as 12 weeks of age. Ocular safety was demonstrated in a rigorous study where cats were treated with up to 6.7 times the label dose for 23 days. 12 Cats were examined using a variety of methods including weekly electroretinography (ERG) using a protocol based upon the international standard for electroretinography (ISCEV), optical coherence tomography (OCT), and histology. Ocular toxicity was not observed during this study. 3 Adverse reactions among cats in a clinical field trial of 282 cats Adverse reactions Pradofloxacin (n = 190) Vehicle (n = 92) Diarrhea/loose stools 7 2 Leukocytosis with neutrophilia 4 6 Elevated CPK levels 4 4 Sneezing 4 1 Hematuria 2 2 Hypersalivation 2 1 Pruritus 2 0 The use of fluoroquinolones in cats has been associated with the development of retinopathy and/or blindness. Such products should be used with caution in cats. The safety of pradofloxacin in cats younger than 12 weeks of age has not been evaluated. The safety of pradofloxacin in cats that are used for breeding or that are pregnant and/or lactating has not been evaluated.

6 Engineered to take bitter out of the picture. Veraflox was engineered to help increase owner compliance. 4 The active ingredient is bound to a fine-grained ion exchange agent that allows the bitterness of the active ingredient to pass the taste buds undetected. In a controlled study, administration of Veraflox was determined to be easy or without difficulty for 73.3% of cats. 5 Study scoring key Patient Acceptance Scoring 3.3% 3.3% 5 = without any difficulties 4 = easy to administer 3 = moderate refusal 43.3% 20% 2 = difficult to administer 1 = unacceptable to patient 30% The safety of pradofloxacin in immune-compromised cats (i.e., cats infected with feline leukemia virus and/or feline immune-deficiency virus) has not been evaluated. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation that may lead to convulsive seizures.

7 abscesses) In a clinical trial in Australia, none of the participating owners reported an inability to medicate their cat with Veraflox.4

8 The next generation of treatment for bacterial skin infections Show owners how easy it can be. In addition to shielding the cat s taste buds from the active ingredient, Veraflox Oral Suspension for Cats is formulated and packaged for ease-of-use to help achieve compliance with your prescribed therapy. Dual targeting of enzymes necessary for bacterial DNA replication* Extensive ocular safety testing 3 Once-daily administration with a convenient, easy-to-deliver suspension Easy-to-use dispenser makes accurate dosing simple Easy-to-use, low-mess dispenser makes accurate dosing easy Convenient, once-daily dosing helps minimize burden on owners May be given with food, efficacy verified in a field study in which cats were fed free-choice or within two hours of dosing 3 Pleasant vanilla taste Discover the science. Veraflox Efficacy. Safety. Ease-of-Use. *The clinical significance of in vitro data has not been demonstrated. 1 Himmler T, Hallenbach W, Marhold A, et al. (2002). Synthesis and in vitro activity of pradofloxacin, a novel 8-cyanofluoroquinolone. In: 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy; San Diego, CA: American Society for Microbiology; Abstract F-566:42. 2 Körber B, Luhmer E, Wetzstein H, Heisig P. (2002). Bactericidal mechanisms of pradofloxacin, a novel 8-cyanofluoroquinolone. In: 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy; San Diego, CA: American Society for Microbiology; Abstract F-567: Freedom of Information Summary: NADA Litster A, Moss S, Honnery M, et al. (2007). Clinical efficacy and palatability of pradofloxacin 2.5% oral suspension for the treatment of bacterial lower urinary tract infections in cats. J Vet Intern Med. 21(5): Data on file. Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, KS. 6 Silley P, Stephan B, Greife H, Pridmore A. (2012). Bactericidal properties of pradofloxacin against veterinary pathogens. Vet Microbiol. 157(2012): Schink, A.-K., et al., Susceptibility of canine and feline bacterial pathogens to pradofloxacin and comparison with other fluoroquinolones approved for companion animals. Vet. Microbial. (2012). 8 Freedom of Information Summary: NADA Freedom of Information Summary: NADA Schentag J, Gilliland K, Paladino J. (2001). What have we learned from pharmacokinetic and pharmacodynamics theories? Clin Infect Dis. 32(suppl 1):S39-S Papich MG. (2011). Enrofloxacin, Marbofloxacin, Orbifloxacin. In: Saunders Handbook of Veterinary Drugs. St. Louis, MO: Elsevier Inc.; , , Messias A, Gekeler F, Wegener A, et al. (2008). Retinal safety of a new fluoroquinolone, pradofloxacin, in cats: assessment with electroretinography. Doc Ophthalmol. 116(3): Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, Kansas Bayer, the Bayer Cross and Veraflox are registered trademarks of Bayer. PRINTED ON 10% POST-CONSUMER PAPER V131285