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For: Subcutaneous use in Beef Cattle, Non-Lactating Dairy Cattle and Swine Only.
DESCRIPTION: Baytril 100 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.
INGREDIENT(S): Each mL of Baytril 100 contains 100 mg of enrofloxacin. Excipients are L-arginine base 200 mg, n-butyl alcohol 30 mg, benzyl alcohol (as a preservative) 20 mg and water for injection q.s.
USES AND INDICATIONS: Cattle - Single-Dose Therapy: Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.
Cattle - Multiple-Day Therapy: Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni (previously Haemophilus somnus) in beef and non-lactating dairy cattle.
Swine: Baytril 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
CONTRAINDICATIONS AND PRECAUTION: . Not For Use In Female Dairy Cattle 20 Months of Age or Older Or In Calves To Be Processed For Veal
The effects of enrofloxacin on cattle or swine reproductive performance, pregnancy and lactation have not been adequately determined.
The long-term effects on articular joint cartilage have not been determined in pigs above market weight.
Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
Baytril 100 contains different excipients than other Baytril® products. The safety and efficacy of this formulation in species other than cattle and swine have not been determined.
Quinolone-class drugs 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 which may lead to convulsive seizures.
Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. See Animal Safety section for additional information.
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
Federal (U.S.A.) law prohibits the extra-label use of this drug in food-producing animals.
ADVERSE EFFECTS AND WARNINGS: No adverse reactions were observed during clinical trials.
For animal use only. Keep out of the reach of children and other animals.
DOSAGE AND ADMINISTRATION: Baytril 100 provides flexible dosages and durations of therapy.
Baytril 100 may be administered as a single dose for one day (cattle and swine) or for multiple days (cattle) of therapy. Selection of the appropriate dose and duration of therapy should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response.
Cattle:
Single-Dose Therapy: Administer once, a subcutaneous dose of 7.5 - 12.5 mg/kg of body weight (3.4 - 5.7 mL/100 lb).
Multiple-Day Therapy: Administer daily, a subcutaneous dose of 2.5 - 5.0 mg/kg of body weight (1.1 - 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.
Administered dose volume should not exceed 20 mL per injection site.
Swine:
Administer once, behind the ear, a subcutaneous dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).
Administered dose volume should not exceed 5 mL per injection site.
STORAGE: Protect from direct sunlight. Do not refrigerate, freeze or store at or above 40°C (104°F). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.
MANUFACTURER: BAYER HEALTHCARE LLC.
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