BAYTRIL- enrofloxacin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Elanco US Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Cattle - Single-Dose Therapy: Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis . Cattle - Multiple-Day Therapy: Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle. Swine: Baytril 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. Baytril 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs whe

Product summary:

Baytril® 100: 100 mg/mL 100 mL Bottle 100 mg/mL 250 mL Bottle 100 mg/mL 500 mL Bottle REFERENCES: For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 1-800-428-4441. Elanco 90206956_PA600217X Revised: January 2022 Baytril is sold by Elanco or its affiliates and is not a product of Bayer. The product name Baytril is owned by Bayer and used under license. Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates. Baytril® 100 Approved by FDA under NADA # 141-068 Manufactured for: Elanco US Inc. Greenfield, IN 46140 U.S.A Made in Germany

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL- ENROFLOXACIN INJECTION, SOLUTION
ELANCO US INC.
----------
_ELANCO_™ BAYTRIL 100
(enrofloxacin)
100 MG/ML ANTIMICROBIAL
INJECTABLE SOLUTION
For Subcutaneous Use In Beef Cattle And Non-Lactating Dairy Cattle
For Intramuscular Or Subcutaneous Use In Swine
Not For Use In Female Dairy Cattle 20 Months Of Age Or Older
Or In Calves To Be Processed For Veal
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.
To assure responsible antimicrobial drug use, enrofloxacin should only
be used as a
second-line drug for colibacillosis in swine following consideration
of other therapeutic
options.
PRODUCT DESCRIPTION:
Baytril 100 is a sterile, ready-to-use injectable antimicrobial
solution that contains
enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.
Each mL of Baytril 100 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:
CATTLE - SINGLE-DOSE THERAPY: Baytril 100 is indicated for the
treatment of bovine
respiratory disease (BRD) associated with _Mannheimia haemolytica,
Pasteurella_
®
_multocida, Histophilus somni_ and _Mycoplasma bovis_ in beef and
non-lactating dairy cattle;
and for the control of BRD in beef and non-lactating dairy cattle at
high risk of
developing BRD associated with _M. haemolytica, P. multocida, H.
somni_ and _M. bovis_.
CATTLE - MULTIPLE-DAY THERAPY: Baytril 100 is indicated for the
treatment of bovine
respiratory disease (BRD) associated with _Mannheimia haemolytica,
Pasteurella_
_multocida_ and _Histophilus somni_ in beef and non-lactating dairy
cattle.
SWINE: Baytril 100 is indicated for the treatment and control of swine
respiratory
disease (SRD) associated with _Actinobacillu