Enroflox ™ 100

Enroflox 100
(enrofloxacin)
™
SWINE PRODUCERS ASKED FOR IT,
NORBROOK DELIVERS…
Introducing New Enrof lox™ 100
The Cost-Effective Alternative to Baytril®100
That Stops SRD in its Tracks
F
DA-Approved, One-Dose Swine Respiratory
Disease (SRD) Treatment and Control
 Same Formulation as Baytril 100
S
ame Active Ingredient as Baytril 100
A
pproved in Pigs of All Ages
Enrof lox 100 Injection …
The NEW Choice
For use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in
food-producing animals. Swine intended for human consumption must not be slaughtered within 5 days of
receiving a single-injection dose. Use with caution in animals with known or suspected CNS disorders. Observe
label directions and withdrawal times. 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 trademark of Norbrook Laboratories Limited
Baytril is a registered trademark of Bayer Animal Health
Enroflox
100
(enrofloxacin)
™
NEW Enroflox 100
Swine Respiratory Disease (SRD) is the prevalent cause of nursery pig and grower/finisher deaths.1 Primary
and secondary bacterial pathogens include Actinobacillus pleuropneumoniae (APP), Pasteurella multocida,
Haemophilus parasuis and Streptococcus suis. These infectious agents act together to increase the severity
and duration of the disease. Making sure your swine herd can perform to their optimum without the setbacks
caused by SRD just got easier … and more cost effective!
COMPARE: Enroflox 100 to Baytril 100 In Swine
Active Ingredient:
Enrofloxacin
Single SQ Injection
Injects Easily
Controls SRD-Causing
Bacteria
Enroflox 100
X
X
X
X
Baytril 100
X
X
X
X
Enroflox
100
(enrofloxacin)
™
PRODUCT DESCRIPTION
 Enroflox 100 is a low-cost alternative to Baytril®100
 Enroflox 100 is an FDA-approved sterile, ready-to-use injectable antimicrobial solution
that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent
 Enroflox 100 works as a single-injection in pigs of all ages
 Enroflox 100 is labeled for the treatment of Swine Respiratory Disease (SRD) associated
with Actinobacillus pleuropneumoniae (APP), Pasteurella multocida, Haemophilus
parasuis and Streptococcus suis
DOSAGE ADMINISTRATION IN SWINE
 Enroflox 100 may be administered as a single SQ dose of 7.5 mg/kg of body weight (3.4 mL/100 lbs.)
 Enroflox 100 dose volume should not exceed 5 mL per injection site
Enroflox 100 DOSE AND TREATMENT SCHEDULE IN SWINE
nroflox 100 may be used as single-dose therapy for the treatment and control of Swine Respiratory Disease
E
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and
Streptococcus suis
Enroflox
100
(enrofloxacin)
™
Weight
(lbs.)
Dose Volume
(mL)
50
1.7
100
150
3.4
5.1
200
250
6.8
8.5
PRODUCT AVAILABILITY
Enroflox 100 is available in convenient 100 mL and 250 mL doses
to fit any size operation.
Contact your veterinarian today for more information
or to purchase new Enroflox 100.
Enroflox 100 Injection … The NEW Choice
™
1 National Animal Health Monitoring System. 1996. Swine `95: Grower/Finisher. Part II. Reference of 1995 U.S. Grower/Finisher Health and Management Practices, p. 14–16. U.S.
Department of Agriculture, Fort Collins, Colo.
Enroflox
100
(enrofloxacin)
™
95, Approved by FDA
xacin)
(enrofloxacin)
Dose Volume (mL)
WEIGHT (lb)
1.7
50
3.4
100
5.1
150
6.8
200
8.5
250
Dose Volume (mL)
1.7
3.4
5.1
6.8
8.5
ANADA 200-495, Approved by FDA
Table 1 – Enroflox 100 Dose and Treatment
TableSchedule
1 – Enroflox 100 Dose and Treatment Schedule
oflox™ 100Enroflox™ 100
100 mg/mL Antimicrobial
Injectable Solution
WEIGHT (lb)
50
100
150
200
250
L Antimicrobial
e Solution
N
N
COOH
N
F
N
Subcutaneous injection
can cause a transient
Subcutaneous
local injection can cause a transient local
COOH
tissue reaction that may result in trim loss
tissue
ofreaction
edible that may result in trim loss of edible
tissue at slaughter.
tissue at slaughter.
O
N effects on articular jointThe
The long-term
cartilage
long-term
haveeffects on articular joint cartilage have
not been determined in pigs above market
not been
weight.
determined in pigs above market weight.
RESIDUE WARNINGS:
eous Use in Swine Only.For Subcutaneous Use in Swine Only. RESIDUE WARNINGS:
Animals intended for human consumption
Animals intended for human consumption
must not be slaughtered within 5 daysmust not be slaughtered within 5 days
CAUTION:
of receiving
single-injection
dose. of receiving a single-injection dose.
A.) law restricts this drugFederal
to use by
(U.S.A.)
or on law restricts this drug
to use bya or
on
licensed veterinarian. the order of a licensed veterinarian.
A.) law prohibits the extra-label
Federaluse
(U.S.A.)
of thislaw prohibits the extra-label use of this
HUMAN WARNINGS:
HUMAN WARNINGS:
producing animals.
drug in food producing animals.
For use in animals only.
For use in animals only.
Keep out of the reach of children.
Keep out of the reach of children.
SCRIPTION:
PRODUCT DESCRIPTION:
Avoid
contact with
eyes. In case of contact,
Avoid contact
immediately
with eyes. In case of contact, immediately
0 is a sterile, ready-to-use
Enroflox™
injectable100 is a sterile,
ready-to-use
injectable
flush eyes with copious amounts of water
flushfor
eyes
15 minutes.
with copious amounts of water for 15 minutes.
solution that contains enrofloxacin,
antimicrobial
a solution that
contains
enrofloxacin,
a
In case ofantimicrobial
dermal contact,
wash skin with
In case
soap
ofand
dermal contact, wash skin with soap and
um fluoroquinolone antimicrobial
broad-spectrum
agent. fluoroquinolone
agent.
water. Consult a physician if irritation persists
water. Consult
following
a physician if irritation persists following
reatment with Enroflox 100
Therapeutic
is administered
treatment with
Enroflox
100
is
administered
dermal exposures. Individuals
ocular
with or
a history
dermalofexposures. Individuals with a history of
ose for one day in swine. as
Each
a single
mL ofdose for oneocular
day in or
swine.
Each
mL
of
hypersensitivity to quinolones should avoid
hypersensitivity
this product.
to quinolones should avoid this product.
contains 100 mg of enrofloxacin.
EnrofloxExcipients
100 contains 100
mg
of
enrofloxacin.
Excipients
humans,
is a30risk
In humans, there is a risk of user photosensitization
e base 200 mg, n-butyl alcohol
are L-arginine
30 mg, base 200 In
mg,
n-butylthere
alcohol
mg,of user photosensitization
within a few
after
excessive
exposure
within atofew hours after excessive exposure to
ol (as a preservative) 20 mg
benzyl
and alcohol
water for
(as a preservative)
20hours
mg and
water
for
quinolones. If excessive accidental exposure
quinolones.
occurs,
If excessive accidental exposure occurs,
injection q.s.
avoid direct sunlight. For customer service,
avoid to
direct
obtain
sunlight.
a
For customer service, to obtain a
copy ofAND
the STRUCTURE:
Material Safety Data Sheetcopy
(MSDS)
of theorMaterial
to
Safety Data Sheet (MSDS) or to
OMENCLATURE AND STRUCTURE:
CHEMICAL NOMENCLATURE
report adverse reactions, call Norbrookreport
at 1-866-591-5777.
adverse reactions, call Norbrook at 1-866-591-5777.
-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,
1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,
xo-3-quinolinecarboxylic4-dihydro-4-oxo-3-quinolinecarboxylic
acid.
acid.
PRECAUTIONS:
PRECAUTIONS:
The effects of enrofloxacin on swine reproductive
The effects of enrofloxacin on swine reproductive
CH3CH2
performance, pregnancy and lactationperformance,
have not been
pregnancy and lactation have not been
adequately determined.
adequately determined.
F
O
S:
INDICATIONS:
Enroflox 100 contains different excipients
Enroflox
than 100
other
contains different excipients than other
s indicated for the treatment
Enroflox
and control
100 is indicated
of
for the treatment and control of
enrofloxacin products. The safety andenrofloxacin
efficacy of this
products. The safety and efficacy of this
tory disease (SRD) associated
swine with
respiratory disease (SRD) associated with
formulation in species other than swine
formulation
have not been
in species other than swine have not been
s pleuropneumoniae, Pasteurella
Actinobacillus pleuropneumoniae, Pasteurella
determined.
determined.
aemophilus parasuis and multocida,
Streptococcus
Haemophilus parasuis and Streptococcus
suis.
Quinolone-class drugs should be usedQuinolone-class
with caution in drugs should be used with caution in
animals with known or suspected Central
animals
Nervous
with known or suspected Central Nervous
D ADMINISTRATION:
DOSAGE AND ADMINISTRATION:
System (CNS) disorders. In such animals,
System
quinolones
(CNS) disorders. In such animals, quinolones
s administered as a single
Enroflox
dose for
100
one
is administered
day
as a single dose for one day
have, in rare instances, been associated
have,
with
in CNS
rare instances, been associated with CNS
in swine.
stimulation which may lead to convulsive
stimulation
seizures.which may lead to convulsive seizures.
Quinolone-class drugs have been shown
Quinolone-class
to produce drugs have been shown to produce
nce, behind the ear, a subcutaneous
Administer once,
dose behind the ear, a subcutaneous dose
erosions of cartilage of weight-bearingerosions
joints and
of cartilage
other
of weight-bearing joints and other
of body weight (3.4 mL/100oflb).
7.5 mg/kg of body weight (3.4 mL/100 lb).
signs of arthropathy in immature animals
signs
of of
various
arthropathy in immature animals of various
species. See Animal Safety section forspecies.
additional
See Animal Safety section for additional
dose volume should not Administered
exceed 5 mL per
dose volume should not exceed 5 mL per
information.
information.
injection site.
STORAGE CONDITIONS:
STORAGE CONDITIONS:
Protect from direct sunlight. Do not refrigerate
Protect from
or freeze.
direct sunlight. Do not refrigerate or freeze.
Store below 77°F (25°C). Precipitation may
Store
occur
below
due
77°F
to cold
(25°C). Precipitation may occur due to cold
temperature. To redissolve, warm and then
temperature.
shake theTovial.
redissolve,052670I01
warm and then shake the vial.
An injection site study conducted in pigs
An demonstrated
injection site study conducted in pigs demonstrated
that the formulation may induce a transient
that the
reaction
formulation
in themay induce a transient reaction in the
subcutaneous tissue. No painful responses
subcutaneous
to
tissue. No painful responses to
administration were observed.
administration were observed.
A second study was conducted in twoApigs
second
weighing
study was conducted in two pigs weighing
approximately 23 kg (50 lb), treated with
approximately
50 mg/kg for23 kg (50 lb), treated with 50 mg/kg for
5 consecutive days. There were no clinical
5 consecutive
signs of days. There were no clinical signs of
toxicity or pathological changes.
toxicity or pathological changes.
ANIMAL SAFETY:
ANIMAL SAFETY:
A safety study was conducted in 32 pigs
A safety
weighing
study was conducted in 32 pigs weighing
approximately 57 kg (125 lb) using single
approximately
doses of 5, 15,
57 or
kg (125 lb) using single doses of 5, 15, or
25 mg/kg daily for 15 consecutive days.25Incidental
mg/kg daily for 15 consecutive days. Incidental
lameness of short duration was observed
lameness
in all groups,
of short duration was observed in all groups,
including the saline-treated controls. including
Musculoskeletal
the saline-treated controls. Musculoskeletal
stiffness was observed following the 15
stiffness
and 25 was
mg/kg
observed following the 15 and 25 mg/kg
treatments with clinical signs appearing
treatments
during the
with
second
clinical signs appearing during the second
week of treatment. Clinical signs of lameness
week of treatment.
improved Clinical signs of lameness improved
after treatment ceased and most animals
afterwere
treatment
clinically
ceased and most animals were clinically
normal at necropsy.
normal at necropsy.
OBSERVE LABEL
TOXICOLOGY:
TOXICOLOGY:
DIRECTIONS
The oral LD50 for laboratory rats was greater
The oralthan
LD50 for laboratory rats was greater than
5000 mg/kg of body weight. Ninety-day5000
feeding
mg/kg
studies
of body
in weight. Ninety-day feeding studies in
dogs and rats revealed no observabledogs
adverse
andeffects
rats revealed
at
no observable adverse effects at
treatment rates of 3 and 40 mg/kg respectively.
treatmentChronic
rates of 3 and 40 mg/kg respectively. Chronic
studies in rats and mice revealed no observable
studies in rats
adverse
and mice revealed no observable adverse
effects at 5.3 and 323 mg/kg respectively.
effects
There
at 5.3
wasand
no 323 mg/kg respectively. There was no
evidence of carcinogenic effect in laboratory
evidence
animal
of carcinogenic
models.
effect in laboratory animal models.
A two-generation rat reproduction study
A two-generation
revealed no rat reproduction study revealed no
effect with 10 mg/kg treatments. No teratogenic
effect witheffects
10 mg/kg treatments. No teratogenic effects
were observed in rabbits at doses of 25
were
mg/kg
observed
or in rats
in rabbits
at
at doses of 25 mg/kg or in rats at
50 mg/kg.
50 mg/kg.
052670I01
OBSERVE LABEL
DIRECTIONS
ADVERSE REACTIONS:
ADVERSE REACTIONS: HOW SUPPLIED:
HOW SUPPLIED:
No adverse reactions were observed during
No adverse
clinical
reactions
trials. were
Enroflox
observed
100:during clinical trials.
Enroflox 100:
100 mg/mL 100 mL Bottle
100 mg/mL 100 mL Bottle
MICROBIOLOGY:
MICROBIOLOGY:
100 mg/mL 250 mL Bottle
100 mg/mL 250 mL Bottle
Enrofloxacin is bactericidal and exertsEnrofloxacin
its antibacterial
is bactericidal and exerts its antibacterial
effect by inhibiting bacterial DNA gyrase
effect
(a type
by inhibiting
II
bacterial
REFERENCES:
DNA gyrase (a type II
REFERENCES:
topoisomerase) thereby preventing DNA
topoisomerase)
supercoiling and
thereby preventing
1. Hooper,DNA
D. C.,supercoiling
Wolfson, J. S.,
andQuinolone
1. Hooper,
Antimicrobial
D. C., Wolfson, J. S., Quinolone Antimic
replication which leads to cell death.1replication
Enrofloxacin
which
is leads toAgents,
cell death.
2nd1 ed,
Enrofloxacin
59 - 75,1993.
is
Agents, 2nd ed, 59 - 75,1993.
active against Gram-negative and Gram-positive
active against
bacteria.
Gram-negative and Gram-positive bacteria.
For customer service, to obtain a copyFor
of the
customer
Material
service, to obtain a copy of the Mat
EFFECTIVENESS:
EFFECTIVENESS:
Safety Data Sheet (MSDS) or to reportSafety
adverse
Data
reactions,
Sheet (MSDS) or to report adverse re
A total of 590 pigs were treated with enrofloxacin
A total of 590injection
pigs were treated
call Norbrook
with enrofloxacin
at 1-866-591-5777.
injection
call Norbrook at 1-866-591-5777.
or saline in two separate natural infection
or saline
SRD in
field
twotrials.
separate natural infection SRD field trials.
For the treatment of SRD, the successFor
ratethe
of treatment of SRD, Restricted
the successDrug
rate-of
California. Use OnlyRestricted
as Directed.
Drug - California. Use Only as Directe
enrofloxacin-treated pigs that were defined
enrofloxacin-treated
as “sick and pigs that were defined as “sick and
febrile” (increased respiratory rate, labored
febrile”or(increased
dyspneic respiratory
Maderate,
in the
labored
UK. or dyspneic
Made in the UK.
breathing, depressed attitude and a rectal
breathing,
temperature
depressed
≥ attitude and a rectal temperature ≥
104.0°F) was statistically significantly greater
104.0°F)than
was the
statistically significantly
Norbrook Laboratories
greater thanLimited
the
Norbrook Laboratories Limited
success rate of saline-treated “sick and
success
febrile”
rate
pigs.
of saline-treated
For
Newry,
“sick
BT35
and6PU,
febrile”
Co. Down,
pigs. For
Newry, BT35 6PU, Co. Down,
the control of SRD, mean rectal temperature,
the control
mortality
of SRD, mean rectal
Northern
temperature,
Ireland mortality
Northern Ireland
(one trial) and morbidity were statistically
(onesignificantly
trial) and morbidity were statistically significantly
lower for enrofloxacin-treated pigs in lower
pens containing
for enrofloxacin-treated
a
pigsTIME
in pens containing a
TAKE
TAKE TIME
percentage of “sick and febrile” pigs compared
percentagetoof “sick and febrile” pigs compared to
saline-treated pigs.
saline-treated pigs.
0813-495-I02A