| FDA Approved Animal Drug Products Online Database System |
| Drug Product Abstract |
Please note that the US Code of Federal Regulations (21 CFR version April 1, 2000) is the official source of regulatory information concerning approved animal drug products.
| Tradename(s) | Baytril 100 Injectable Solution |
| Sponsor | Bayer Corp., Agriculture Division, Animal Health |
| Ingredient(s) | Enrofloxacin |
| Species | Cattle, beef, all; Cattle, calves, excluding veal calves |
| Route(s) | Subcutaneous |
| DoseForm(s) | Liquid |
| Withdrawal Time | Cattle: 28 days before slaughter. |
CFR Indications
| 522.812 Enrofloxacin solution.
Specifications. Each milliliter of sterile solution contains either 22.7 milligrams of enrofloxacin when intended for use in dogs or 100 milligrams of enrofloxacin when intended for use in cattle. Conditions of use: Cattle Amount: Single-dose therapy: 7.5 to 12.5 milligrams enrofloxacin per kilogram of body weight (3.4 to 5.7 milliliters per 100 pounds). Multiple-day therapy: 2.5 to 5.0 milligrams per kilogram of body weight (1.1 to 2.3 milliliters per 100 pounds) administered subcutaneously once daily for 3 to 5 days. Indications: For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. Limitations: For subcutaneous use in cattle only. Do not inject more than 20 milliliters at each site. Do not slaughter within 28 days of last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. The effect of enrofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined. 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. |
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