Enroflox Injection

Enroflox
Injection
(enrofloxacin)
®
For Dogs 2.27%
KEY BENEFITS
DOSAGE AND ADMINISTRATION
ame active ingredient, formulation and dosing
S
regimen as Baytril® Injectable Solution 2.27%
Concentration-dependent and bactericidal
Kills a broad range of Gram (+) and Gram (-) Bacteria
Significant savings versus Baytril Injectable
Solution 2.27%
Concentration (mcg/mL)
Serum Concentrations Of Enrofloxacin Following A
Single Oral Or Intramuscular Dose At 2.5 mg/kg In Dogs
1.2
Dogs Injectable
1.0
Dogs Tablets
0.8
0.6
Enroflox Injection May Be
Administered As Follows:
Weight Of Enroflox® Injection
For Dogs* 2.5 mg/kg
Animal
4.5 kg (10 lb.)
6.8 kg (15 lb.)
9.1 kg (20 lb.)
11.3 kg (25 lb.)
13.6 kg (30 lb.)
15.9 kg (35 lb.)
18.1 kg (40 lb.)
20.4 kg (45 lb.)
22.7 kg (50 lb.)
0.50 mL
0.75 mL
1.00 mL
1.25 mL
1.50 mL
1.75 mL
2.00 mL
2.25 mL
2.50 mL
*The initial Enroflox Injection administration should be followed
12 hours later by initiation of enrofloxacin tablet therapy.
0.4
HOW SUPPLIED:
0.2
0
Enroflox Injection may be used as the initial dose
at 2.5 mg/kg. It should be administered intramuscularly
(IM) as a single dose, followed by initiation of
enrofloxacin tablet therapy.
0
1
2
3
4
5
6
7
8
Time In Hours
9 10 11 12
Enroflox® (enrofloxacin) Injection is a fluoroquinolone
designed for the management of bacterial diseases, with
broad-spectrum activity against both gram-negative and
gram-positive bacteria including those causing dermal,
urinary and respiratory tract infections. Each mL of injectable solution contains 22.7 mg of enrofloxacin. Enroflox
Injection is available for dogs only.
Enroflox Injection is available in 20 mL and exclusive
100 mL vials to fit any practice.
Enroflox
Injection
(enrofloxacin)
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra label use of this
drug in food-producing animals. CONTRAINDICATIONS: Enrofloxacin is contraindicated in dogs known to be hypersensitive to quinolones. The
safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. The use of enrofloxacin is
contraindicated in small and medium breed dogs during the rapid growth phase (between 2 and 8 months of age). WARNINGS: For
use in animals only. The use of this product in cats may result in Retinal Toxicity. Keep out of reach of children. Observe
label directions and see product labeling for full product information.
FOR VETERINARY USE ONLY
www.norbrookinc.com
The Norbrook logos are registered trademarks of Norbrook Laboratories Limited
Enroflox is a registered trademark of Norbrook Laboratories Limited
Baytril is a registered trademark of Bayer Animal Health
®
, Approved by FDA
Isolates
30
20
20
10
10
20
10
Organisms
MIC
Range (mcg/mL)
E. coli0.06-2.0
P. mirabilis
0.125-2.0
K. pneumoniae
0.06-0.5
P. aeruginosa
1.0-8.0
Enterobacter
0.06-1.0 spp.
Staph.0.125-0.5
(coag. +)
Strep. (alpa
0.5-8.0hemol.)
Isolates
30
20
20
10
10
20
10
MIC Range (mcg/mL)
0.06-2.0
0.125-2.0
0.06-0.5
1.0-8.0
0.06-1.0
0.125-0.5
0.5-8.0
TABLEUrinary
II – MICPathogens
Values for Enrofloxacin Against Canine Urinary Pathogens
ANADA 200-513, Approved by FDA
TABLE II – MIC Values for Enrofloxacin Against Canine
(Diagnostic laboratory isolates, 1985)
(Diagnostic laboratory isolates, 1985)
Organisms
E. coli
P. mirabilis
K. pneumoniae
P. aeruginosa
Enterobacter spp.
®
Enroflox™
roflox™(enrofloxacin)
floxacin)
2.27%
Staph.Dogs
(coag. +)
tion For DogsInjection For
Strep. (alpa hemol.)
in the
Body: Enrofloxacin penetrates into all canine tissues
Distribution in the Body: Enrofloxacin penetratesDistribution
into all canine
tissues
and
body fluids.
Concentrations
of drug equal to or greater than the MIC
and body fluids. Concentrations of drug equal to or
greater
than the
MIC
for manyinpathogens
(See
For Dogs Only
for many pathogens (See Tables I, II and III) are reached
most tissues
by Tables I, II and III) are reached in most tissues by
two hours
afterhours
dosing
at 2.5 mg/kg and are maintained for 8-12 hours after
two hours after dosing at 2.5 mg/kg and are maintained
for 8-12
after
Particularly
CAUTION:
dosing. Particularly high levels of enrofloxacin aredosing.
found in
urine. A high levels of enrofloxacin are found in urine. A
summary
the body
fluid/tissue
drug levels at 2 to 12 hours after dosing at
drug to use
by or
on fluid/tissue
the order ofdrug
a levels at 2 to
of the
body
12 hoursofafter
dosing
at
law restricts this drug to use by orFederal
on the (U.S.A.)
order oflaw
a restricts thissummary
2.5 mg/kg is given in Table III.
licensed veterinarian.
2.5 mg/kg is given in Table III.
arian.
Isolates
2
3
2
1
4
10
6
4
5
Organisms
MIC
Range (mcg/mL)
Bacteroides
2 spp.
Bordatella
bronchiseptica
0.125-0.5
Brucella
canis
0.125-0.25
Clostridium
0.5 perfringens
Escherichia
coli
≤0.016-0.031
Klebsiella
spp.
0.031-0.5
Proteus
mirabilis
0.062-0.125
Pseudomonas
0.5-8 aeruginosa
Staphylococcus
spp.
0.125
Isolates
2
3
2
1
4
10
6
4
5
MIC Range (mcg/mL)
2
0.125-0.5
0.125-0.25
0.5
≤0.016-0.031
0.031-0.5
0.062-0.125
0.5-8
0.125
TABLE IIIin– Dogs
Body Fluid/Tissue distribution of Enrofloxacin in Dogs
Federal law prohibitsTABLE
the extralabel
of this drugdistribution of Enrofloxacin
III – Bodyuse
Fluid/Tissue
eral law prohibits the extralabel use of this drug
Single Oral Dose = 2.5 mg/kg (1.13 mg/lb)
in food-producing
Single Oralanimals.
Dose = 2.5 mg/kg (1.13 mg/lb)
in food-producing animals.
Post-treatment Enrofloxacin Levels Canine (n=2) Post-treatment Enrofloxacin Levels Canine (n=2)
DESCRIPTION:
2 Hr.
8 Hr.
Enrofloxacin
is a synthetic
agent from the class of the 2 Hr. Body Fluids (mcg/mL)
Body Fluids (mcg/mL)
8 Hr.
a synthetic chemotherapeutic agent
from the class
of the chemotherapeutic
43.05
55.35
quinoloneactivity
carboxylic
acida derivatives.
Urine It has antibacterial activity against a43.05 Urine
55.35
oxylic acid derivatives. It has antibacterial
against
0.53
0.66
broad
spectrum
Gram Inegative
and
Gram positive bacteria (See Tables I 0.53 Eye Fluids 0.66
Eye
Fluids
of Gram negative and Gram positive
bacteria
(SeeofTables
1.01
0.36
and II). Each22.7
mLmg,
of injectable solution
Wholecontains:
Blood enrofloxacin 22.7 mg,
1.01 Whole Blood 0.36
L of injectable solution contains: enrofloxacin
0.67
0.33
alcohol
mg, potassiumPlasma
hydroxide for pH adjustment and water 0.67 Plasma
0.33
30 mg, potassium hydroxide for pHn-butyl
adjustment
and30water
Tissues (mcg/g) Hematopoietic System
for injection, q.s.
Tissues (mcg/g) Hematopoietic System
.
3.02
1.36
Liver
3.02 Liver
1.36
1.45
0.85
STRUCTURAL FORMULA:
Spleen
1.45 Spleen
0.85
MENCLATURE AND STRUCTURALCHEMICAL
FORMULA: NOMENCLATURE AND
2.10
1.22
Bone Marrow
2.10 Bone Marrow1.22
-(4-ethyl-1-piperazinyl)-6-fluoro-1,1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,
1.32
0.91
4-dihydro-4-oxo-3-quinolinecarboxylic
Lymph acid.
Node
1.32 Lymph Node 0.91
-3-quinolinecarboxylic acid.
Urogenital System
Urogenital System
CH3CH2
3CH2
1.87
0.99
Kidney
1.87 Kidney
0.99
N
N
1.36
0.98
Bladder Wall
1.36 Bladder Wall 0.98
1.36
1.10
Testes
1.36 Testes
1.10
1.36
2.20
Prostate
1.36 Prostate
2.20
1.59
0.29
Uterine Wall
1.59 Uterine Wall 0.29
N
N GastrointestinalN and Cardiopulmonary Systems Gastrointestinal and Cardiopulmonary Systems
N
1.34
0.82
Lung
1.34 Lung
0.82
1.88
0.78
Heart
1.88 Heart
0.78
3.24
2.16
Stomach
3.24 Stomach
2.16
COOH
F
COOH
F
2.10
1.11
Small Intestine
2.10 Small Intestine1.11
Other
Other
0.52
0.40
Fat
0.52 Fat
0.40
O
O
0.66
0.48
ACTIONS:
Skin
0.66 Skin
0.48
1.62
0.77
Microbiology:
Quinolone
acid derivatives are classified as DNA 1.62 Muscle
Muscle
0.77
Quinolone carboxylic acid derivatives
are classified
as DNA carboxylic
0.25
0.24
gyrase
inhibitors.
The mechanism
of action of these compounds is very 0.25 Brain
Brain
0.24
s. The mechanism of action of these
compounds
is very
0.45
0.21
not yet
fully understood.
The site
of action is bacterial gyrase,0.45 Mammary Gland
Mammary
Gland
0.21
t yet fully understood. The site of complex
action is and
bacterial
gyrase,
1.65
9.97
a synthesis
enzyme. The
effect of Escherichia coli is the
Feces
1.65 Feces
9.97
moting enzyme. The effect of Escherichia
colipromoting
is the
of DNA synthesis through prevention of DNA supercoiling.
A synthesis through prevention of inhibition
DNA supercoiling.
Pharmacokinetics:
In dogs, the absorption and elimination characteristics
other
things, such compounds
lead to the cessation
cell
Pharmacokinetics:
In dogs,ofthe
absorption and elimination
characteristics
ngs, such compounds lead to the Among
cessation
of cell
of the oral
formulation are linear (plasma concentrations increase
respiration
and division. They may
alsooral
interrupt
bacterial
of the
formulation
are membrane
linear (plasma concentrations
increase
division. They may also interrupt bacterial
membrane
proportionally
with
dose) when enrofloxacin is administered at up to 11.5
integrity.1
proportionally with dose) when enrofloxacin is administered
at up
to 11.5
2 Approximately 80% of the orally administered dose
mg/kg,
twice daily.
administered
dose
mg/kg, twice daily.2 Approximately 80% of the orally
Enrofloxacin
is bactericidal,
withenters
activity
against
bothcirculation
Gram negative
and The eliminating
enters the systemic
circulation unchanged. The eliminating organs, based
the
systemic
unchanged.
organs, based
bactericidal, with activity against both
Gram negative
and
Gram positive bacteria.
concentrations
(MICs)
on thethe
drug’s
time, can readily remove the drug with no
on theinhibitory
drug’s body
clearance time,
can readily remove
drugbody
with clearance
no
acteria. The minimum inhibitory concentrations
(MICs) The minimum
were determined
isolatesthat
representing
9 genera
of
indicationThe
thatprimary
the eliminating mechanisms are saturated. The primary
indication
the eliminating
mechanisms
are saturated.
d for a series of 37 isolates representing
9 genera offor a series of 37
from
naturalofinfections in
dogs,
because
of excretion is via the urine. The absorption and elimination
route
of selected
excretionprincipally
is via the urine.
Theofabsorptionroute
and elimination
atural infections in dogs, selected bacteria
principally
because
resistance
to one or more of the characteristics
following antibiotics:
ampicillin,
characteristics
beyond this point are unknown. Saturable absorption
beyond
this point are unknown. Saturable
absorption
e or more of the following antibiotics:
ampicillin,
cephalothin,
colistin, chloramphenicol,
gentamicin,
and/or
elimination
and/or erythromycin,
elimination processes
may occur at greater
doses.
When processes may occur at greater doses. When
istin, chloramphenicol, erythromycin,
gentamicin,
penicillin, streptomycin,
tetracycline,
triple sulfa process
and
saturation
of the absorption
process occurs, the plasma concentration of
saturation
of the absorption
occurs, the plasma
concentration
of
icillin, streptomycin, tetracycline, kanamycin,
triple sulfa and
sulfa/trimethoprim.
The MIC values
for enrofloxacin
isolates based
theonactive
moiety will
be less than predicted, based on the concept of dose
the active
moiety willagainst
be lessthese
than predicted,
the concept
of dose
im. The MIC values for enrofloxacin
against these isolates
are presented
in Table
of these organisms were found to be
proportionality.
proportionality.
n Table I. Most strains of these organisms
were found
to I.beMost strains
enrofloxacin
in vitro but the clinical significance has not
nrofloxacin in vitro but the clinicalsusceptible
significancetohas
not
been determined for some of theFollowing
isolates. an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb),
Following
an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb), enrofloxacin
enrofloxacin
d for some of the isolates.
50% ofand
its maximum
serum concentration in 15 minutes and peak
reached 50% of its maximum serum concentrationreached
in 15 minutes
peak
The susceptibility
of using
organisms to
enrofloxacin
should
be determined
serumhalf-life
level was
reached
serum
level was
reached
in one hour.using
The elimination
in dogs
is in one hour. The elimination half-life in dogs is
ty of organisms to enrofloxacin should
be determined
enrofloxacin
mcg disks.
for susceptibility
testing
should
be
approximately 2 ½ -3 hours at that dose.
approximately
2 ½ -3 hours
at that
dose.
mcg disks. Specimens for susceptibility
testing 5should
be Specimens
collected prior to the initiation of enrofloxacin therapy.
o the initiation of enrofloxacin therapy.
A graph
the mean serum levels following a dose of 2.5 mg/kg
A graph indicating the mean serum levels following
a doseindicating
of 2.5 mg/kg
TABLEPathogens
I – MIC Values for Enrofloxacin
Against
Canine
(1.13inmg/lb)
(1.13 mg/lb)
in dogs
(oralPathogens
and intramuscular) is shown
FigureinI.dogs (oral and intramuscular) is shown in Figure I.
Values for Enrofloxacin Against Canine
(Diagnostic laboratory isolates, 1984)
oratory isolates, 1984)
ringens
p.
chiseptica
s
eruginosa
s spp.
MIC (µg/mL)
≤ 0.5
1
≥2
Zone Diameter (mm)
Interpretation
≥ 21
Susceptible
(S)
18-20
Intermediate
(I)
17
Resistant≤(R)
(90, dogs
45 andreceived
14 days)10prior to breeding or when female dogs received
onafter
pharmacokinetic
enrofloxacin
in dogs after
a female
(90, 45studies
and 14ofdays)
prior to breeding
or when
Breakpoint: Based on pharmacokinetic studies ofBreakpoint:
enrofloxacinBased
in dogs
a
daily treatments
single
oral half
administration
of 2.5 mg consecutive
enrofloxacin/kg
(i.e. half of
dailyBW
treatments
ofthe
15 mg/kg/day at 4consecutive
intervals; between
30 and 0 of 15 mg/kg/day at 4 intervals; betwee
single oral administration of 2.5 mg enrofloxacin/kg
BW (i.e.
of the
to breeding,
early pregnancy (between 10th and 30th day
lowest-end
single
daily
dose range)days
and prior
the data
listed in Tables
I and II, the(betweendays
to breeding,
early pregnancy
10th prior
and 30th
days), late
lowest-end single daily dose range) and the data listed
in Tables
I and
II, the
pregnancy
following
for canine
isolates.
pregnancy
(between
40th and 60th days), and during
lactation(between
(the first 40th
28 and 60th days), and during lactation (the f
following breakpoints are recommended for canine
isolates.breakpoints are recommended
days).
days).
MIC (µg/mL)
Interpretation
DRUG INTERACTIONS:
≤ 0.5 INTERACTIONS:
Susceptible (S)
DRUG
Concomitant
therapy
with other drugs that are metabolized in the liv
1
Intermediate
(I) drugs that are metabolized
Concomitant
therapy
with other
in the
liver may
reduce
clearance rates of the quinolone and the other drug.
≥ 2 the clearance
Resistant
reduce
rates (R)
of the quinolone and the
otherthe
drug.
Zone Diameter (mm)
≥ 21
18-20
≤ 17
Enrofloxacin
has of
been
administered to dogs at a daily dosage rate o
A report
of “Susceptible”
that the pathogen
is likely
to be inhibited
has been
administered
to dogs at a daily
dosage rate
10 mg/kg
A report of “Susceptible” indicates that the pathogen
is likely
to be inhibitedindicatesEnrofloxacin
concurrently
with a wide variety of other health products including
generally achievable
A report of
“Intermediate”
concurrently
with
a wide varietyisofa other health products
including
by generally achievable plasma levels. A report ofby“Intermediate”
is a plasma levels.
technical
and isolates fallinganthelmintics
into this category
should befebantel),
retested. insecticidesanthelmintics
(praziquantel,
(pyrethrins), (praziquantel,
heartworm febantel), insecticides (pyrethrins), hea
technical buffer and isolates falling into this category
shouldbuffer
be retested.
preventatives
(diethylcarbamazine) and other antibiotics (ampicillin
Alternatively
the organism
if the infection isand
in aother antibiotics
preventativestreated
(diethylcarbamazine)
(ampicillin,
Alternatively the organism may be successfully treated
if the infection
is in amay be successfully
gentamicin
penicillin). No incompatibilities are known with
body A
site
where
drug is physiologically
concentrated.
report of “Resistant”
gentamicin
sulfate, A
penicillin).
No incompatibilities
are knownsulfate,
with other
body site where drug is physiologically concentrated.
report
of “Resistant”
drugs at this time.
thattothe
are unlikely to be inhibitory
drugs at this time.
indicates that the achievable drug concentrationsindicates
are unlikely
beachievable
inhibitory drug concentrations
and other therapy should be selected.
and other therapy should be selected.
WARNINGS:
WARNINGS:
Standardized
proceduresforrequire the
use
of
laboratory
control
organisms
for
Standardized procedures require the use of laboratory
control organisms
usemay
in animals
The use of this product in cats may result
For use
animals only.
The use
of thisThe
product inFor
cats
result inonly.
Retinal
both standardized
disk diffusion
andinstandardized
dilution
assays.
both standardized disk diffusion assays and standardized
dilution assays.
The assays
Toxicity. Keep out of reach of children.
Toxicity.
Keep
outdiameters
of reach of
children.
5 µgdiameters
enrofloxacin
following
zone
and
5 µg enrofloxacin disk should give the following zone
anddisk should give the
Avoid contact
with with
eyes. In case of contact, immediately flush eyes
contact with
case
of contact, immediately
flush eyes
powder should provideAvoid
the following
MICeyes.
valuesInfor
reference
enrofloxacin powder should provide the followingenrofloxacin
MIC values for
reference
amounts
ofwash
water for 15 minutes. In case of dermal contac
copious amounts of water for 15 minutes. In casecopious
of dermal
contact,
strains.
strains.
skin withpersists
soap and
water. Consult a physician if irritation persists fo
skin with soap and water. Consult a physician if irritation
following
ocular
or dermal exposure.
QC Strain
MICocular
(µg/mL)
Zone
DiameterIndividuals
(mm)
or dermal
exposure.
with a history
of hypersensitivity
to Individuals with a history of hypersensi
QC Strain
MIC (µg/mL)
Zone Diameter
(mm)
quinolones shoulduser
avoid this product. In humans, there is a risk of u
E. coli ATCC 25922
0.008 - 0.03
32 - 40
quinolones
should
avoid
this
product.
In
humans,
there
is
a
risk
of
E. coli ATCC 25922
0.008 - 0.03
32
40
photosensitization
within a few hours after excessive exposure to q
P. aeruginosa
1-4
15 - 19
photosensitization
within
a few hours after excessive
exposure to quinolones.
P. aeruginosa ATCC 27853
1-4
15 - 19 ATCC 27853
If excessive
S. aureus
27 -exposure
31
If excessive accidental
occurs, avoid direct
sunlight.accidental exposure occurs, avoid direct sunlight.
S. aureus ATCC 25923
27 -ATCC
31 25923
For customer
service,
S. aureus ATCC 29213
0.03
For- 0.12
customer service, to obtain a copy of the Material
Safety Data
Sheetto obtain a copy of the Material Safety Data S
S. aureus ATCC 29213
0.03 - 0.12
(MSDS)
or to report adverse reactions call Norbrook at 1-866-591-5
(MSDS) or to report adverse reactions call Norbrook
at 1-866-591-5777.
INDICATIONS:
INDICATIONS:
™ (brand of enrofloxacin) Injectable Solution is indicated for the
PRECAUTION:
Enroflox
is indicated
for the
PRECAUTION:
Enroflox™ (brand of enrofloxacin) Injectable Solution
of diseases
with bacteria
susceptible
to with caution
Quinolone-class
should
management of diseases in dogs associated withmanagement
bacteria susceptible
to in dogs associated
Quinolone-class
drugs should
be used
in animals withdrugs
known
or be used with caution in animals with
enrofloxacin.
suspected
Nervous System (CNS) disorders. In such anima
enrofloxacin.
suspected Central Nervous System (CNS) disorders.
In suchCentral
animals,
quinolones
in rare instances, been associated with CNS stimu
quinolones have, in rare instances, been associated
with CNShave,
stimulation
EFFICACY CONFIRMATION:
EFFICACY CONFIRMATION:
which may lead to convulsive seizures.
which may lead to convulsive seizures.
Clinical
efficacy
Clinical efficacy was established in dermal infections
(wounds
andwas established in dermal infections (wounds and
with susceptible
strains of Escherichia
Klebsiella
drugs
abscesses) associated with susceptible strains ofabscesses)
Escherichiaassociated
coli, Klebsiella
Quinolone-class
drugs havecoli,
been
associated withQuinolone-class
cartilage erosions
in have been associated with cartilage erosion
pneumoniae,
Proteus
mirabilis, andweight-bearing
Staphylococcusjoints
intermedius;
weight-bearing
andofother forms of arthropathy in immature an
pneumoniae, Proteus mirabilis, and Staphylococcus
intermedius;
respiratory
and otherrespiratory
forms of arthropathy
in immature joints
animals
various species.
infections
(pneumonia,
tonsillitis, rhinitis)
infections (pneumonia, tonsillitis, rhinitis) associated
with susceptible
strains
variousassociated
species. with susceptible strains
of Escherichia
coliassociated
and Staphylococcus aureus and urinary cystitis associated
of Escherichia coli and Staphylococcus aureus and
urinary cystitis
The use
of fluoroquinolones
The coli,
use of
fluoroquinolones
in cats has been reported
to adversely
affect the in cats has been reported to adversely
with
susceptible
Proteus
mirabilis, and
with susceptible strains of Escherichia coli, Proteus
mirabilis,
and strains of Escherichia
retina.
Such products should be used with caution in cats.
retina. Such products should be used with caution
in cats.
Staphylococcus aureus
Staphylococcus aureus
DOSAGE AND ADMINISTRATION:
DOSAGE AND ADMINISTRATION:
CONTRAINDICATIONS:
CONTRAINDICATIONS:
Enroflox
for Dogs
Enroflox
Injection
for Dogs may be
dose Injection
at 2.5 mg/kg.
It may be used as the initial dose at 2.5 mg
Enrofloxacin
is contraindicated
in dogs
known
to be hypersensitive
to used as the initial
Enrofloxacin is contraindicated in dogs known to be
hypersensitive
to
be administered
should be administered intramuscularly (IM) as a should
single dose,
followed byintramuscularly (IM) as a single dose, follow
quinolones.
quinolones.
initiation of enrofloxacin tablet therapy.
initiation of enrofloxacin tablet therapy.
on the
studies
discussed under the section on Animal Safety Summary,
Based on the studies discussed under the sectionBased
on Animal
Safety
Summary,
Enroflox
EnrofloxinInjection
Dogs may
be administered
as
follows:Injection for Dogs may be administered as follows:
of enrofloxacin
contraindicated
small andfor
medium
breeds
of dogs
the use of enrofloxacin is contraindicated in smallthe
anduse
medium
breeds of isdogs
during the
rapidThe
growth
during the rapid growth phase (between 2 and 8 months
of age).
safephase
use (between 2 and 8 months of age). The safe use
Weight
Animal
Enroflox™ Injection for Dog
forOfDogs*
Animal
Enroflox™ Injection
of enrofloxacin
not been
in largeOfand
giant breeds during the
of enrofloxacin has not been established in large and
giant breedshas
during
the establishedWeight
2.5 mg/kg
2.5 mg/kg
rapid growth
phase.
Large
rapid growth phase. Large breeds may be in this phase
for up to
one year
of breeds may be in this phase for up to one year of
9.1 kg (20 lb)
1.00 mL
9.1 kg (20 lb)
1.00 mL
age andfield
thetrials
giantutilizing
breeds for
In
clinical
field
trials
utilizing
a
age and the giant breeds for up to 18 months. In clinical
a up to 18 months.
27.2 kg (60 lb)
3.00 mL
kg (60
lb)
3.00 mL
oral doseorofjoint
5.0 mg/kg, there were no 27.2
reports
of lameness
or joint
daily oral dose of 5.0 mg/kg, there were no reportsdaily
of lameness
problems
in any breed. However, controlled
studies
with
histological
problems in any breed. However, controlled studies
with histological
*Theshould
initial be
Enroflox
Injection
*The initial
Enroflox
Injection
for Dogs administration
followed
12 for Dogs administration should be follo
examination
havelater
not by
been
conducted
in the largetablet
or therapy.
examination of the articular cartilage have not been
conductedofinthe
thearticular
large orcartilage
hours later by initiation of enrofloxacin tablet therapy.
hours
initiation
of enrofloxacin
giant breeds.
giant breeds.
The lower
limit in
ofdogs
the dose range was based on efficacy studies in d
The lower limit of the dose range was based on efficacy
studies
ADVERSE REACTIONS:
ADVERSE REACTIONS:
administered at 2.5 mg/kg twice daily. Targ
where enrofloxacin was administered at 2.5 mg/kgwhere
twiceenrofloxacin
daily. Targetwas
animal
drug-related
side effects
in 122
clinicalstudies
cases treated
withto establish
No drug-related side effects were reported in 122No
clinical
cases treated
with were reported
safety
toxicology
studies were used to establish the upper limit
safety and
toxicology
were used
theand
upper
limit of the
an enrofloxacin
injectable
an enrofloxacin injectable solution followed by enrofloxacin
tablets
at 5.0 solution followed by enrofloxacin tablets at 5.0
dose
range
and
treatment
duration.
dose
range
and
treatment
duration.
mg/kg per day.
mg/kg per day.
To report adverse reactions, call Norbrook
at 1-866-591-5777
To report adverse reactions, call Norbrook at 1-866-591-5777
STORAGE:
STORAGE:
59°-77°F
Excursions permitted up to 86°F (30°C)
Store at 59°-77°F (15°-25°C). Excursions permittedStore
up toat86°F
(30°C).(15°-25°C).
Brief
ANIMAL SAFETY SUMMARY:
ANIMAL SAFETY SUMMARY:
exposure
temperature
exposure to temperature up to 104°F (40°C) may be
toleratedtoprovided
the up to 104°F (40°C) may be tolerated provid
dogs
receiving
enrofloxacin
orally
a dailytemperature
dosage ratedoes
of 52not
mg/kg
for 77°F (25°C);
Adult dogs receiving enrofloxacin orally at a dailyAdult
dosage
rate
of 52 mg/kg
for
mean kinetic
temperature
does not exceed 77°F (25°C); however, su
meanatkinetic
exceed
however,
such
weeks
had only isolated
of vomition
Adultfrom directexposure
13 weeks had only isolated incidences of vomition13and
inappetence.
Adult incidences
minimized. Protect from direct sunlight. Do not
exposure
shouldand
beinappetence.
minimized. Protect
sunlight.should
Do notbe
freeze.
dogs receiving
tablet formulation for 30 consecutive days at a daily
dogs receiving the tablet formulation for 30 consecutive
days at athe
daily
treatment
25 mg/kg
did not exhibitHOW
significant
clinical signs nor were there
treatment of 25 mg/kg did not exhibit significant clinical
signsofnor
were there
HOW SUPPLIED:
SUPPLIED:
upon theparameters.
clinical chemistry, Enroflox
hematological
or histological
effects upon the clinical chemistry, hematologicaleffects
or histological
Enroflox
Injection
for Dogs Vialparameters.
Sizes 20 mL and 100
mL Injection for Dogs Vial Sizes 20 mL and 100 mL
dosesinappetence,
of 125 mg/kg for up to 11 days induced vomition, inappetence,
Daily doses of 125 mg/kg for up to 11 days inducedDaily
vomition,
REFERENCES:
depression,
difficult 50
locomotion andREFERENCES:
death while adult dogs receiving 50
depression, difficult locomotion and death while adult
dogs receiving
1
1 Dougherty,
Dougherty, T.J.
and Saukkonen, J.J. Membrane Permeability Chan
mg/kg/day
for 14 days had clinical signs
of vomition
inappetence.J.J. Membrane Permeability
T.J. and Saukkonen,
Changes
mg/kg/day for 14 days had clinical signs of vomition
and inappetence.
Associated
with DNA Gyrase Inhibitors in Escherichia coli. Antimic
Associated with DNA Gyrase Inhibitors in Escherichia
coli. Antimicrob.
Adultat
dogs
for
threeand
treatments
at 12.5
Adult dogs dosed intramuscularly for three treatments
12.5dosed
mg/kgintramuscularly
followed
Agents
Chemoth.,
V. 28,mg/kg
Aug. followed
1985: 200-206. Agents and Chemoth., V. 28, Aug. 1985: 200-206.
by 57 oraldid
treatments
at 12.5 mg/kg, all at 12 hour intervals, did not exhibit
by 57 oral treatments at 12.5 mg/kg, all at 12 hour intervals,
not exhibit
2 Walker, R.D., et al. Pharmacokinetic Evaluation of Enrofloxacin Ad
2
significant
clinical signs or effects
upon
theetclinical
chemistry,
Walker,
R.D.,
al. Pharmacokinetic
Evaluation of
Enrofloxacin Administered
either significant clinical signs or effects upon theeither
clinical
chemistry,
Orally
to Healthy
Dogs. Am.J.Res., V. 53, No. 12, Dec. 1992: 2315-231
hematological or histological parameters.
Orally to Healthy Dogs. Am.J.Res., V. 53, No. 12, Dec.
1992:
2315-2319.
hematological or histological parameters.
047670I01
OBSERVE LABEL
DIRECTIONS
TAKE TIME
Made in the UK.
Oralwith
treatment
of 15 torates
28 week
growing
puppies
in the
UK. with daily dosage rates of
Oral treatment of 15 to 28 week old growing puppies
daily dosage
of old Made
25 mg/kg
abnormal
carriage of the carpal joint and weakness in
25 mg/kg has induced abnormal carriage of the carpal
jointhas
andinduced
weakness
in
Norbrook
logos are registered trademarks of Norbrook Laborat
The Norbrook
logos
are is
registered
Norbrook
Laboratories
the hindquarters.
Significant improvement
of clinical
signs
observedtrademarks of The
the hindquarters. Significant improvement of clinical
signs is observed
Limited.
Limited.
following
drug lesions
withdrawal.
studies have identified lesions of the
following drug withdrawal. Microscopic studies have
identified
of theMicroscopic
articular
cartilage
following
articular cartilage following 30 day treatments at either
5, 15
or 25 mg/kg
in 30 day treatments at either 5, 15 or 25 mg/kg in
Enroflox
Enroflox
is
a
trademark
of
Norbrook
Laboratories
Limited. is a trademark of Norbrook Laboratories Limited.
thisorage
group. Clinical
signs of difficult ambulation or associated cartilage
this age group. Clinical signs of difficult ambulation
associated
cartilage
Norbrook Laboratories Limited
Norbrook
Laboratories
Limited
lesions
havefollowing
not beendaily
observed in 29
to 34 week
old puppies
following daily
lesions have not been observed in 29 to 34 week old
puppies
Newry, BT35 6PU, Co. Down,
Newry,days
BT35nor
6PU,
Down,
treatments
25puppies
mg/kg for
30 consecutive
in Co.
2 week
old puppies with
treatments of 25 mg/kg for 30 consecutive days nor
in 2 weekofold
with
Northern Ireland
Northern Ireland
the same treatment schedule.
the same treatment schedule.
Tests
no effect on circulatingTAKE
microfilariae
or adult heartworms
Tests indicated no effect on circulating microfilariae
or indicated
adult heartworms
TIME
(Dirofilaria
dogs were treated at a daily dosage rate of 15 mg/kg
(Dirofilaria immitis) when dogs were treated at a daily
dosageimmitis)
rate of when
15 mg/kg
for 30
days. No effect on cholinesterase values was observed.
for 30 days. No effect on cholinesterase values was
observed.
OBSERVE
LABEL parameters when male
Noparameters
adverse effects
reproductive
No adverse effects were observed on reproductive
whenwere
maleobserved on
DIRECTIONSof 15 mg/kg/day at 3 intervals
receivedat103consecutive
dogs received 10 consecutive daily treatments of dogs
15 mg/kg/day
intervals daily treatments
ENROFLOX INJ FOR DOGS
ENROFLOX INJ FOR DOGS
The urinary
inhibitory
activity on 120 isolates of seven canine urinary pathogens
ctivity on 120 isolates of seven canine
pathogens
was also investigated and is listed
in Table
II.
Figure
1 – Serum
Concentrations of Enrofloxacin Figure 1 – Serum Concentrations of Enrofloxacin
gated and is listed in Table II.
a Single
Following a Single Oral or Intramuscular Dose at Following
2.5 mg/kg in
Dogs. Oral or Intramuscular Dose at 2.5 mg/kg in Dogs.
1014-513-I01F