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:

Bayer HealthCare LLC Animal Health Division

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 p

Product summary:

Baytril® 100:         100 mg/mL          100 mL Bottle         100 mg/mL          250 mL Bottle         100 mg/mL          500 mL Bottle

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL- ENROFLOXACIN INJECTION, SOLUTION
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
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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) associa