Technical Specs:
NUFLOR GOLD™
Rx Product
Intervet/Schering-Plough Animal Health
(florfenicol)
NADA 141-265, Approved by FDA.
Injectable Solution, An Antimicrobial
300 mg/mL
For subcutaneous use in beef and
non-lactating dairy cattle only
Not for use in female dairy cattle 20
months of age or older or in calves to be processed for veal
CAUTION: Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: NUFLOR GOLD™ is an
injectable solution of the synthetic antibiotic florfenicol. Each
milliliter of sterile NUFLOR GOLD™ contains 300 mg of florfenicol, 300
mg of 2-pyrrolidone, and triacetin qs.
INDICATIONS: NUFLOR GOLD™ is
indicated for treatment of bovine respiratory disease (BRD) associated
with Mannheimia haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis in beef and non-lactating dairy cattle.
DOSAGE AND ADMINISTRATION: NUFLOR
GOLD™ should be administered once by subcutaneous injection at a dose
rate of 40 mg florfenicol/kg body weight (6 mL/100 lb). Do not
administer more than 15 mL at each site. The injection should be given
only in the neck. Injection sites other than the neck have not been
evaluated.
NUFLOR GOLD™ Dosage Guide ANIMAL WEIGHT
(lb)
|
DOSAGE
(mL)
|
|
100
|
6.0
|
|
200
|
12.0
|
|
300
|
18.0
|
|
400
|
24.0
|
|
500
|
30.0
|
|
600
|
36.0
|
|
700
|
42.0
|
|
800
|
48.0
|
|
900
|
54.0
|
|
1000
|
60.0 |
CONTRAINDICATIONS: Do not use in
animals that have shown hypersensitivity to florfenicol.
WARNINGS: NOT FOR HUMAN USE. KEEP OUT OF
REACH OF CHILDREN. This product contains materials that can be
irritating to skin and eyes. Avoid direct contact with skin, eyes, and
clothing. In case of accidental eye exposure, flush with water for 15
minutes. In case of accidental skin exposure, wash with soap and water.
Remove contaminated clothing. Consult a physician if irritation
persists. Accidental injection of this product may cause local
irritation. Consult a physician immediately. The Material Safety Data
Sheet (MSDS) contains more detailed occupational safety information.
For customer service, to report suspected adverse
reactions, or to obtain a copy of the MSDS, call 1-800-211-3573.
PRECAUTIONS: Not for use in animals
intended for breeding purposes. The effects of florfenicol on bovine
reproductive performance, pregnancy, and lactation have not been
determined. Toxicity studies in dogs, rats, and mice have associated the
use of florfenicol with testicular degeneration and atrophy.
Subcutaneous injection in cattle can cause a transient
local tissue reaction that may result in trim loss of edible tissue at
slaughter.
|
RESIDUE WARNINGS: Animals intended
for human consumption must not be slaughtered within 44 days of
treatment. Do not use in female dairy cattle 20 months of age or older.
Use of florfenicol in this class of cattle may cause milk residues. A
withdrawal period has not been established in pre-ruminating calves. Do
not use in calves to be processed for veal.
|
|
ADVERSE REACTIONS: Transient
inappetence, diarrhea, decreased water consumption, and injection site
swelling have been associated with the use of florfenicol in cattle. In
addition, anaphylaxis and collapse have been reported post-approval with
the use of another formulation of florfenicol in cattle.
CLINICAL PHARMACOLOGY: The
pharmacokinetic disposition of NUFLOR GOLD™ was evaluated in feeder
calves following single subcutaneous injection at a dose rate of 40 mg
florfenicol/kg body weight. Administration of NUFLOR GOLD™ resulted in
florfenicol plasma concentrations of 2 µg (mcg)/mL within two hours of
injection. Table 1. Pharmacokinetic
Parameter Values for Florfenicol Following a Single Subcutaneous
Injection of NUFLOR GOLD™ at a Dose Rate of 40 mg Florfenicol/kg Body
Weight to Feeder Calves (n=24).
|
|
Cmax
(µg/mL)
|
Tmax
(hr)
|
AUClast
(µg*hr/mL)
|
T1/2
(hr)
|
|
n
|
24
|
24
|
24
|
232
|
|
Mean
|
5.93
|
51
|
150
|
37.7
|
|
% CV
|
38.3
|
2-121
|
20.9
|
27.3
|
Cmax: Maximum observed
plasma concentration
Tmax: Time at which Cmax is observed
AUClast: Area under the
plasma-concentration-time curve from time zero to the last quantifiable
concentration that is equal to or greater than the limit of
quantification of the validated analytical method
T1/2: Terminal elimination
half-life
% CV: Percent coefficient of variance
1 Tmax
is presented as the median value or range of observed values (minimum
to maximum)
2 T1/2
value could not be accurately estimated for one calf Table 1. Pharmacokinetic
Parameter Values for Florfenicol Following a Single Subcutaneous
Injection of NUFLOR GOLD™ at a Dose Rate of 40 mg Florfenicol/kg Body
Weight to Feeder Calves (n=24).
|
|
Cmax
(µg/mL)
|
Tmax
(hr)
|
AUClast
(µg*hr/mL)
|
T1/2
(hr)
|
|
n
|
24
|
24
|
24
|
232
|
|
Mean
|
5.93
|
51
|
150
|
37.7
|
|
% CV
|
38.3
|
2-121
|
20.9
|
27.3
|
Cmax: Maximum observed
plasma concentration
Tmax: Time at which Cmax is observed
AUClast: Area under the
plasma-concentration-time curve from time zero to the last quantifiable
concentration that is equal to or greater than the limit of
quantification of the validated analytical method
T1/2: Terminal elimination
half-life
% CV: Percent coefficient of variance
1 Tmax
is presented as the median value or range of observed values (minimum
to maximum)
2 T1/2
value could not be accurately estimated for one calf
| 
