ENROFLOX 100- enrofloxacin injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Ladda ner Produktens egenskaper (SPC)
21-01-2019

Aktiva substanser:

enrofloxacin (UNII: 3DX3XEK1BN) (enrofloxacin - UNII:3DX3XEK1BN)

Tillgänglig från:

MWI/VetOne

Administreringssätt:

SUBCUTANEOUS

Receptbelagda typ:

PRESCRIPTION

Terapeutiska indikationer:

Cattle - Single-Dose Therapy: Enroflox 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: Enroflox 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: Enroflox 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 . Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pig

Produktsammanfattning:

Enroflox 100:

Bemyndigande status:

Abbreviated New Animal Drug Application

Produktens egenskaper

                                ENROFLOX 100- ENROFLOXACIN INJECTION, SOLUTION
MWI/VETONE
----------
ANADA 200-495, Approved by FDA
VETone
ENROFLOX
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:
Enroflox
100 is a sterile, ready-to-use injectable antimicrobial solution that
contains enrofloxacin, a
broad-spectrum fluoroquinolone antimicrobial agent. Each mL of
Enroflox 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-3quinolinecarboxylic acid.
INDICATIONS:
CATTLE - SINGLE-DOSE THERAPY: Enroflox 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: Enroflox 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: Enroflox 100 is indicated for the treatment and control of
swine respiratory disease (SRD)
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