Baytril 100-CA1: Product Information (Page 2 of 2)

ADVERSE REACTIONS:

No adverse reactions were observed during Baytril® 100 clinical trials.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY:

Pharmacokinetics: Following a single subcutaneous dose of 12.5 mg/kg body weight in eight beef heifers and steers, enrofloxacin reached a mean maximum plasma concentration (Cmax ) of 1.39 mg/L at 4.25 hours after dosing. Ciprofloxacin, which is the main active metabolite of enrofloxacin, started appearing in the blood approximately 20 minutes after dosing and had a Cmax of 0.59 mg/L at 6.25 hours after dosing. The mean area under the concentration curve to the last quantifiable concentration timepoint (AUClast ) for enrofloxacin and ciprofloxacin was 12.38 and 7.13 mg*hr/L, respectively. The mean half-life was 4.15 hours for enrofloxacin and 5.15 hours for ciprofloxacin.

Mechanism of Action: Enrofloxacin and ciprofloxacin work by inhibiting the function of the topoisomerases gyrase and topoisomerase IV in the bacterial cell. Typically, gyrase is the primary target in Gram-negative bacteria, and topoisomerase IV is the primary target in Gram-positive bacteria. These enzymes are necessary for bacterial DNA synthesis. Their inhibition by these drugs leads to several types of lethal cell damage by mechanisms that are complex and not completely understood, and results in cessation of cell respiration and division.

MICROBIOLOGY:

Enrofloxacin is bactericidal and exerts its antibacterial effect by inhibiting bacterial DNA gyrase (a type II topoisomerase) thereby preventing DNA supercoiling and replication which leads to cell death.1 Enrofloxacin is active against Gram-negative and Gram-positive bacteria.

REASONABLE EXPECTATION OF EFFECTIVENESS:

Baytril® 100-CA1 is conditionally approved pending a full demonstration of effectiveness. Additional information for conditional approvals can be found by searching https://www.fda.gov for “conditional approval”. Baytril® 100-CA1 (enrofloxacin) has a reasonable expectation of effectiveness for treatment of clinical anaplasmosis in the conditionally approved classes of cattle when administered for the conditionally approved dosage regimen based on published scientific literature and reports from studies conducted by the sponsor. The information evaluated effectiveness across a variety of study designs, including differences in: dose, frequency, duration, and route of administration; animal class and age (including young calves and adult cows); infection method (natural vs. challenge); and product formulation. Despite the variation in study design, the studies consistently showed that administration of enrofloxacin in A. marginale -infected cattle resulted in a decrease in parasitemia and, when evaluated, improvement in clinical variables (hematocrit and rectal temperatures).

ANIMAL SAFETY:

Safety studies were conducted in feeder calves using single doses of 5, 15 and 25 mg/kg for 15 consecutive days and 50 mg/kg for 5 consecutive days. No clinical signs of toxicity were observed when a dose of 5 mg/kg was administered for 15 days. Clinical signs of depression, incoordination and muscle fasciculation were observed in calves when doses of 15 or 25 mg/kg were administered for 10 to 15 days. Clinical signs of depression, inappetance and incoordination were observed when a dose of 50 mg/kg was administered for 3 days. No drug-related abnormalities in clinical pathology parameters were identified. No articular cartilage lesions were observed after examination of stifle joints from animals administered 25 mg/kg for 15 days.

A safety study was conducted in 23-day-old calves using doses of 5, 15 and 25 mg/kg for 15 consecutive days. No clinical signs of toxicity or changes in clinical pathology parameters were observed. No articular cartilage lesions were observed in the stifle joints at any dose level at 2 days and 9 days following 15 days of drug administration.

An injection site study conducted in feeder calves demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue and underlying muscle. No painful responses to administration were observed.

Reproductive Safety: Two reproductive safety studies were conducted to evaluate the effect of enrofloxacin administered to pregnant cows. In one study, enrofloxacin was administered to 347 beef cows at critical times (folliculogenesis, and early, middle, and late organogenesis) during the first trimester of pregnancy. In the second study, enrofloxacin was administered to 30 late gestation (third trimester) dairy cows. A nontreated control group was included in both studies. Reproductive efficiencies (conception rate and pregnancy attrition rate for the first trimester study; and calving rate, calving failure rate, abortion rate, stillborn rate, and dystocia scores for both studies) and cow health were evaluated. Calves born to study cows were assessed for congenital anomalies, body weight, and general health through 60 days post-partum. Enrofloxacin treatment had no adverse effect on reproduction or cow health in either study. Three calves in the first trimester study that were born to enrofloxacin-treated cows died due to perforating gastrointestinal ulcers. No congenital anomalies were observed in either study, and calf body weights and general health were otherwise normal.

STORAGE CONDITIONS:

Protect from direct sunlight. Do not refrigerate or freeze. Store at 20-30ºC (68-86ºF), excursions permitted up to 40ºC (104ºF). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.

HOW SUPPLIED:

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

REVISION DATE:

January 2020

REFERENCES:

1. Hooper, D. C., Wolfson, J. S., Quinolone Antimicrobial Agents, 2nd ed., 59-75, 1993.

For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Bayer Veterinary Product Support at 1-800-422-9874. For product questions call 1-800-255-6826.
Bayer logo

87079104 LV2001
©2020 Bayer HealthCare LLC
Baytril® 100-CA1
Bayer, the Bayer Cross and Baytril are registered trademarks of Bayer.
Bayer HealthCare LLC, Animal Health Division
Shawnee Mission, Kansas 66201 U.S.A.
Made in Germany

Principal Display Panel – 250 mL Carton Label

Baytril 100-CA1 (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution 250 mL Carton Label
(click image for full-size original)

Baytril® 100-CA1
(enrofloxocin)

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.

250 mL

Bayer HealthCare LLC, Animal Health Division
Shawnee Mission, Kansas 66201 U.S.A.
Made in Germany

Principal Display Panel – 250 mL Unit Label

Baytril 100-CA1 (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution 250 mL Unit Label
(click image for full-size original)

Baytril® 100-CA1
(enrofloxocin)

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.

250 mL

Bayer

BAYTRIL 100-CA1
enrofloxacin injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-3025
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENROFLOXACIN (ENROFLOXACIN) ENROFLOXACIN 100 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-3025-02 1 BOTTLE in 1 CARTON contains a BOTTLE (0859-3025-01)
1 NDC:0859-3025-01 250 mL in 1 BOTTLE This package is contained within the CARTON (0859-3025-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Conditional NADA NADA141527 04/10/2020
Labeler — Bayer HealthCare, LLC Animal Health Division (152266193)

Revised: 11/2020 Bayer HealthCare, LLC Animal Health Division

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