Country: United States
Language: English
Source: NLM (National Library of Medicine)
ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN)
Elanco US Inc.
SUBCUTANEOUS
PRESCRIPTION
Baytril 100-CA1 is indicated for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.
Baytril 100-CA1: 100 mg/mL 250 mL Bottle REVISED: January 2022
Conditional New Animal Drug Application
BAYTRIL 100-CA1- ENROFLOXACIN INJECTION, SOLUTION ELANCO US INC. ---------- BAYTRIL 100-CA1 (ENROFLOXACIN) 100 MG/ML ANTIMICROBIAL INJECTABLE SOLUTION For subcutaneous use in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves. CONDITIONALLY APPROVED BY FDA PENDING A FULL DEMONSTRATION OF EFFECTIVENESS UNDER APPLICATION NUMBER 141-527. CAUTION: 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. PRODUCT DESCRIPTION: Baytril 100-CA1 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent. Each mL of Baytril 100-CA1 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. CHEMICAL NOMENCLATURE AND STRUCTURE: 1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. ® INDICATIONS: Baytril 100-CA1 is indicated for the treatment of clinical anaplasmosis associated with _Anaplasma marginale_ in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves. DOSAGE AND ADMINISTRATION: Baytril 100-CA1 should be administered as a single dose for treatment of clinical anaplasmosis. Administer, by subcutaneous injection, a single dose of 12.5 mg/kg of body weight (5.7 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site. BAYTRIL 100-CA1 DOSE FOR ANAPLASMOSIS* *Dose volumes have been rounded to the nearest 0.5 mL. Weight (lb) Single-Dose Therapy 12.5 mg/kg Dose Volume (mL) 500 28.5 600 Read the complete document