BAYTRIL 100-CA1- enrofloxacin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN)

Available from:

Bayer HealthCare, LLC Animal Health Division

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic 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.

Product summary:

Baytril® 100-CA1: 100 mg/mL       250 mL Bottle

Authorization status:

Conditional New Animal Drug Application

Summary of Product characteristics

BAYTRIL 100-CA1- ENROFLOXACIN INJECTION, SOLUTION
BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION
----------
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
*
Weight (lb)
Single-Dose Therapy
12.5 mg/kg
Dose Volume (mL)
500
28.5
600
34.0
700
40.0
800