Baytril 100-CA1: Product Information

BAYTRIL 100-CA1- enrofloxacin injection, solution
Bayer HealthCare, LLC Animal Health Division


Animals image

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.

Chemical structureChemical structure

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

34.0

700

40.0

800

45.5

900

51.5

1000

57.0

1100

62.5

1200

68.5

1300

74.0

1400

80.0

1500

85.5

1600

91.0

1700

97.0

1800

102.5

1900

108.5

2000

114.0

Use within 30 days of first puncture and puncture a maximum of 30 times with a needle or 4 times with a dosage delivery device. Any product remaining beyond these parameters should be discarded.

RESIDUE WARNINGS:

arrow Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for use in female dairy cattle 20 months of age or older including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. arrow

HUMAN WARNINGS:

Not for use in humans. Keep out of reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.

PRECAUTIONS:

The effects of enrofloxacin on bull reproductive performance have not been adequately determined.

Subcutaneous injection in cattle can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Baytril® 100 and Baytril® 100-CA1 contain different excipients than other Baytril® products. The safety and efficacy of this formulation in species other than cattle has 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.

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