baytril 100 (enroﬂ oxacin) injectable approved for ... · subcutaneous injection of baytril 100...

Several placebo-controlled studies were conducted that demonstrated and confirmed the effectiveness of Baytril 100 for treating and controlling swine respiratory disease (SRD) associated with M. hyopneumoniae and B. bronchiseptica. These studies are summarized below. Baytril ® 100 (enrofloxacin) Injectable Approved for Treatment and Control of Swine Respiratory Disease Associated with Mycoplasma hyopneumoniae and Bordetella bronchiseptica ©2016 Bayer, Shawnee Mission, Kansas 66201. Bayer, the Bayer Cross, Baytril and Right the first time are registered trademarks of Bayer. BL15188 Study #1: M. hyopneumoniae Treatment — Challenge Study Objective: Evaluate the efficacy of a single subcutaneous injection of Baytril 100 at 7.5 mg/kg of body weight (3.4 mL/100 lb) in a M. hyo challenge model. Conclusions: The mean total lung lesion scores were significantly reduced in the Baytril 100 group compared to the placebo control group with scores of 4% and 27% (P< 0.0001), respectively. Significant reductions in percentage of days with abnormal cough score were observed in the Baytril 100 group (13.9%, P< 0.0001) compared to the placebo control group (53.8%). Study #2: M. hyopneumoniae and B. bronchiseptica Treatment — Field Study Objective: Confirm the efficacy of a single subcutaneous injection of Baytril 100 at 7.5 mg/kg for treatment of naturally occurring SRD associated with M. hyo infection. Conclusions: Overall mean treatment success rates were significantly higher for the Baytril 100 group compared to placebo controls at two study sites. • Site 1: Treatment success rates were 61.3% and 26.7% (P< 0.0001) for the Baytril 100 and placebo control groups, respectively. • Site 2: Treatment success rates were 92.0% and 33.3% (P< 0.0001) for the Baytril 100 and placebo control groups, respectively. B. bronchiseptica were also found to be present in the test population. Study #3: M. hyopneumoniae and B. bronchiseptica Control — Field Study Objective: Assess the efficacy of a single subcutaneous injection of Baytril 100 at 7.5 mg/kg for control of naturally occurring SRD associated in a M. hyo infection. Conclusions: Overall mean treatment success rates were significantly higher for the Baytril 100 group compared to placebo controls. Treatment success rates were 69.5% and 48.5% (P< 0.0001) for the Baytril 100 and placebo control groups, respectively. B. bronchiseptica were also found to be present in the test population. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Extra-label use of this drug in food-producing animals is prohibited. Swine intended for human consumption must not be slaughtered within 5 days of receiving a single- injection dose.

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Page 1: Baytril 100 (enroﬂ oxacin) Injectable Approved for ... · subcutaneous injection of Baytril 100 at 7.5 mg/kg for control of naturally occurring SRD associated in a M. hyo infection

Several placebo-controlled studies were conducted that demonstrated and confi rmed the effectiveness of Baytril 100 for treating and controlling swine respiratory disease (SRD) associated with M. hyopneumoniae and B. bronchiseptica. These studies are summarized below.

Baytril® 100 (enrofl oxacin) Injectable Approved for Treatment and Control of Swine Respiratory Disease Associated with Mycoplasma hyopneumoniae and Bordetella bronchiseptica

Study #1: M. hyopneumoniae Treatment — Challenge StudyObjective: Evaluate the effi cacy of a single subcutaneous injection of Baytril 100 at7.5 mg/kg of body weight (3.4 mL/100 lb) in a M. hyo challenge model.

Conclusions: The mean total lung lesion scores were signifi cantly reduced in the Baytril 100 group compared to the placebo control group with scores of 4% and 27% (P< 0.0001),respectively. Signifi cant reductions in percentage of days with abnormal cough score were observed in the Baytril 100 group (13.9%, P< 0.0001) compared to the placebo control group (53.8%).

Study #2: M. hyopneumoniae and B. bronchiseptica Treatment — Field StudyObjective: Confi rm the effi cacy of a single subcutaneous injection of Baytril 100 at 7.5 mg/kg for treatment of naturally occurring SRD associated with M. hyo infection.

Conclusions: Overall mean treatment success rates were signifi cantly higher for the Baytril 100 group compared to placebo controls at two study sites. • Site 1: Treatment success rates were 61.3% and 26.7% (P< 0.0001) for the Baytril 100 and placebo control groups, respectively. • Site 2: Treatment success rates were 92.0% and 33.3% (P< 0.0001) for the Baytril 100 and placebo control groups, respectively.B. bronchiseptica were also found to be present in the test population.

Study #3: M. hyopneumoniae and B. bronchiseptica Control — Field StudyObjective: Assess the effi cacy of a single subcutaneous injection of Baytril 100 at7.5 mg/kg for control of naturally occurring SRD associated in a M. hyo infection.

Conclusions: Overall mean treatment success rates were signifi cantly higher for the Baytril 100 group compared to placebo controls. Treatment success rates were 69.5% and 48.5%(P< 0.0001) for the Baytril 100 and placebo control groups, respectively. B. bronchiseptica were also found to be present in the test population.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Extra-label use of this drug in food-producing animals is prohibited. Swine intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.