ENROMED- enrofloxacin injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bimeda, Inc.

Laluan pentadbiran:

SUBCUTANEOUS

Jenis preskripsi:

PRESCRIPTION

Tanda-tanda terapeutik:

INDICATIONS: Cattle - Single-Dose Therapy: EnroMed™ 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: EnroMed™ 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: EnroMed™ 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. EnroMed™ 100 is indicated for the control of colibacillosis in groups or pens of

Ringkasan produk:

HOW SUPPLIED: EnroMed™ 100, 100 mg/mL is available in 100 mL, 250 mL and 500 mL multi-dose vials.

Status kebenaran:

Abbreviated New Animal Drug Application

Ciri produk

ENROMED- ENROFLOXACIN INJECTION, SOLUTION
BIMEDA, INC.
----------
APPROVED BY FDA UNDER ANADA # 200-598
ENROMED 100
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:
EnroMed™ 100 is a sterile, ready-to-use injectable antimicrobial
solution that contains
enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.
Each mL of EnroMed™ 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: EnroMed™ 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: EnroMed™ 100 is indicated for the
treatment of
bovine respiratory disease (BRD) associated with _Mannheimia
haemolytica, Pasteurella_
TM
_multocida _and_Histophilus somni_ in beef and non-lactating dairy
cattle.
SWINE: EnroMed™ 100 is indicated for the treatment and control of
swine respiratory
disease (SRD) associate