www.norbrookinc.com

The Norbrook logos are registered trademarks of Norbrook Laboratories Limited Enroflox is a trademark of Norbrook Laboratories LimitedBaytril is a registered trademark of Bayer Animal Health

SWINE PRODUCERS ASKED FOR IT, NORBROOK DELIVERS…

FDA-Approved, One-Dose Swine Respiratory Disease (SRD) Treatment and Control

Same Active Ingredient as Baytril® 100

Approved for Pigs of All Ages

Enroflox 1(enrofloxacin)

00®

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.

Enroflox  ® 100(enrofloxacin)

FOR VETERINARY USE ONLY

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 for pigs of all ages Enroflox 100 is approved for the treatment and control of Swine Respiratory Disease (SRD)

associated with Actinobacillus pleuropneumoniae (APP), Pasteurella multocida, Haemophi-lus parasuis and Streptococcus suis

PRODUCT DESCRIPTION

Active Ingredient: Enrofloxacin

Single SQ Injection Injects Easily Controls SRD

Enroflox® 100

Baytril® 100

X

X

X

X

X

X

X

X

ENROFLOX® 100Swine 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.

Enroflox 1(enrofloxacin)

00®

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

DOSAGE ADMINISTRATION IN SWINE

Enroflox 1(enrofloxacin)

00®

Enroflox 100 is available in convenient 100 mL and 250 mL bottles to fit any size operation.

PRODUCT AVAILABILITY

Contact your veterinarian today for more information or to purchase new Enroflox 100.

Enroflox 100 may be used as single-dose therapy for the treatment and control of Swine Respiratory Disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis

ENROFLOX® 100 DOSE AND TREATMENT SCHEDULE IN SWINE

Enroflox 1(enrofloxacin)

00®

Weight(lbs.)

Dose Volume(mL)

50100150200250

1.73.45.16.88.5

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.

ANAD

A 20

0-49

5, A

ppro

ved

by F

DA

For S

ubcu

tane

ous U

se in

Bee

f Cat

tle, N

on-L

acta

ting D

airy

Cat

tle an

d Sw

ine O

nly.

Not f

or U

se in

Fema

le D

airy

Cat

tle 20

Mon

ths o

f Age

or O

lder

Or I

n Cal

ves

To B

e Pro

cess

ed Fo

r Vea

l.

CAUT

ION:

Fede

ral (U

.S.A

.) law

restr

icts t

his dr

ug to

use b

y or o

n the

orde

r of a

lic

ense

d vet

erina

rian.

Fede

ral (U

.S.A

.) law

proh

ibits

the e

xtra-

label

use o

f this

drug

in

food

-pro

ducin

g anim

als.

PROD

UCT D

ESCR

IPTI

ON:

Enro

flox®

100 i

s a st

erile

, read

y-to

-use

injec

table

antim

icrob

ial so

lution

that

co

ntain

s enr

oflox

acin,

a br

oad-

spec

trum

fluor

oquin

olone

antim

icrob

ial

agen

t.Ea

ch m

L of E

nrof

lox 10

0 con

tains

100 m

g of e

nrof

loxac

in. Ex

cipien

ts ar

e L-

argin

ine ba

se 20

0 mg,

n-bu

tyl al

coho

l 30 m

g, be

nzyl

alcoh

ol (a

s a

pres

erva

tive)

20 m

g and

wat

er fo

r injec

tion q

.s.

CHEM

ICAL

NOM

ENCL

ATUR

E AND

STR

UCTU

RE:

1-cy

clopr

opyl-

7-(4-

ethy

l-1-p

ipera

zinyl)

-6-fl

uoro

-1,

4-dih

ydro

-4-o

xo-3

-quin

oline

carb

oxyli

c acid

.

INDI

CATI

ONS:

Cattl

e - S

ingl

e-Do

se Th

erap

y: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t of

bovin

e res

pirat

ory d

iseas

e (BR

D) as

socia

ted w

ith M

annh

eimia

haem

olytic

a, Pa

steur

ella m

ultoc

ida, H

istop

hilus

somn

i and

Myc

oplas

ma

bovis

in be

ef an

d non

-lact

ating

dairy

cattle

; and

for t

he co

ntro

l of B

RD in

be

ef an

d non

-lact

ating

dairy

cattle

at hi

gh ris

k of d

evelo

ping B

RD

asso

ciate

d with

M. h

aemo

lytica

, P. m

ultoc

ida, H

. som

ni an

d M. b

ovis.

Cattl

e - M

ultip

le-D

ay Th

erap

y: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t of

bovin

e res

pirat

ory d

iseas

e (BR

D) as

socia

ted w

ith M

annh

eimia

haem

olytic

a, Pa

steur

ella m

ultoc

ida an

d Hist

ophil

us so

mni in

beef

and

non-

lacta

ting d

airy c

attle

.

Swin

e: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t and

cont

rol o

f swi

ne

resp

irato

ry di

seas

e (SR

D) as

socia

ted w

ith A

ctino

bacil

lus

pleur

opne

umon

iae, P

aste

urell

a mult

ocida

, Hae

moph

ilus p

aras

uis an

d St

rept

ococ

cus s

uis.

DOSA

GE A

ND A

DMIN

ISTR

ATIO

N:En

roflo

x 100

prov

ides f

lexibl

e dos

ages

and d

urat

ions o

f ther

apy.

Enro

flox 1

00 m

ay be

admi

niste

red a

s a si

ngle

dose

for o

ne da

y for

tre

atme

nt an

d con

trol o

f BRD

(cat

tle) a

nd S

RD (s

wine

), or f

or m

ultipl

e day

s fo

r BRD

trea

tmen

t (cat

tle). S

elect

ion of

the a

ppro

priat

e dos

e and

dura

tion

of th

erap

y for

BRD

trea

tmen

t in ca

ttle sh

ould

be ba

sed o

n an a

sses

smen

t of

the s

ever

ity of

the d

iseas

e, pa

thog

en su

scep

tibilit

y and

clini

cal

resp

onse

.

Cattl

e:Si

ngle

-Dos

e The

rapy

(BRD

Trea

tmen

t): A

dmini

ster, b

y sub

cuta

neou

s inj

ectio

n, a s

ingle

dose

of 7.

5-12

.5 mg

/kg of

body

weig

ht (3

.4-5.7

mL/1

00 lb

).

Mul

tiple

-Day

Ther

apy (

BRD

Trea

tmen

t): A

dmini

ster d

aily,

a sub

cuta

neou

s

dose

of 2.

5-5 m

g/kg

of bo

dy w

eight

(1.1-

2.3 m

L/100

lb). T

reat

ment

shou

ld be

re

peat

ed at

24-h

our in

terv

als fo

r thr

ee da

ys. A

dditio

nal tr

eatm

ents

may b

e giv

en on

Day

s 4 an

d 5 to

anim

als th

at ha

ve sh

own c

linica

l impr

ovem

ent b

ut

not to

tal re

cove

ry.

Sing

le-D

ose T

hera

py (B

RD C

ontro

l): A

dmini

ster, b

y sub

cuta

neou

s inj

ectio

n, a s

ingle

dose

of 7.

5 mg/

kg of

body

weig

ht (3

.4 mL

/100 l

b).

Exam

ples o

f con

dition

s tha

t may

cont

ribut

e to c

alves

being

at hi

gh ris

k for

de

velop

ing B

RD in

clude

, but

are n

ot lim

ited t

o, th

e foll

owing

:• T

rans

porta

tion w

ith an

imals

from

two o

r mor

e far

m or

igins

.• A

n exte

nded

tran

spor

t time

with

few

to no

rest

stops

.• A

n env

ironm

enta

l temp

erat

ure c

hang

e of ≥

30°F

durin

g tra

nspo

rtatio

n.• A

≥30

°F ra

nge i

n tem

pera

ture

fluct

uatio

n with

in a 2

4-ho

ur pe

riod.

• Exp

osur

e to w

et or

cold

weat

her c

ondit

ions.

• Exc

essiv

e shr

ink (m

ore t

han w

ould

be ex

pect

ed w

ith a

norm

al loa

d of

cattle

).• S

tress

ful a

rriva

l pro

cess

ing pr

oced

ures

(e.g.

castr

ation

or de

horn

ing).

• Exp

osur

e with

in th

e prio

r 72 h

ours

to an

imals

show

ing cl

inica

l sign

s of

BRD.

Admi

niste

red d

ose v

olume

shou

ld no

t exc

eed 2

0 mL p

er in

jectio

n site

.

Tabl

e 1 –

Enro

flox 1

00 D

ose a

nd Tr

eatm

ent S

ched

ule f

or C

attle

*

Tr

eatm

ent

Cont

rol

Sing

le-D

ose

Mul

tiple

-Day

Si

ngle

-Dos

e

Th

erap

y Th

erap

y Th

erap

y

7.5

- 12

.5 mg

/kg

2.5 -

5.0 m

g/kg

7.5

mg/

kg

WEI

GHT

Dose

Volu

me

Dose

Volu

me

Dose

Volu

me

(lb)

(mL)

(mL)

(mL)

10

0 3.5

- 5.5

1.5 - 2

.0 3.5

20

0 7.0

- 11.0

2.5

- 4.5

7.0

300

10.5

- 17.0

3.5

- 6.5

10.5

40

0 14

.0 - 2

2.5

4.5 - 9

.0 14

.0

500

17.0

- 28.5

5.5

- 11.5

17

.0

600

20.5

- 34.0

7.0

- 13.5

20

.5

700

24.0

- 39.5

8.0

- 16.0

24

.0

800

27.5

- 45.5

9.0

- 18.0

27

.5

900

31.0

- 51.0

10

.0 - 2

0.5

31.0

10

00

34.0

- 57.0

11

.0 - 2

3.0

34.0

11

00

37.5

- 62.5

12

.5 - 2

5.0

37.5

*Dos

e volu

mes h

ave b

een r

ound

ed to

the n

eare

st 0.5

mL w

ithin

the d

ose

rang

e.

Swin

e:Ad

minis

ter, b

y sub

cuta

neou

s (be

hind t

he ea

r) inj

ectio

n, a s

ingle

dose

of 7.

5 mg

/kg of

body

weig

ht (3

.4 mL

/100 l

b).

Admi

niste

red d

ose v

olume

shou

ld no

t exc

eed 5

mL p

er in

jectio

n site

.

Tabl

e 2 –

Enro

flox 1

00 D

ose a

nd Tr

eatm

ent S

ched

ule f

or S

win

e

W

EIGH

T (lb

) Do

se Vo

lume

(mL)

50

1.7

10

0 3.4

15

0 5.1

20

0 6.8

25

0 8.5

RESI

DUE W

ARNI

NGS:

Cattl

e: A

nimals

inte

nded

for h

uman

cons

umpt

ion m

ust n

ot be

sla

ught

ered

with

in 28

days

from

the l

ast tr

eatm

ent. T

his pr

oduc

t is

not a

ppro

ved f

or fe

male

dairy

cattle

20 m

onth

s of a

ge or

olde

r, inc

luding

dry d

airy c

ows.

Use i

n the

se ca

ttle m

ay ca

use d

rug

resid

ues i

n milk

and/

or in

calve

s bor

n to t

hese

cows

. A w

ithdr

awal

perio

d has

not b

een e

stabli

shed

for t

his pr

oduc

t in pr

e-ru

mina

ting

calve

s. Do

not u

se in

calve

s to b

e pro

cess

ed fo

r vea

l.Sw

ine:

Anim

als in

tend

ed fo

r hum

an co

nsum

ption

mus

t not

be

slaug

hter

ed w

ithin

5 day

s of r

eceiv

ing a

single

-injec

tion d

ose.

HUM

AN W

ARNI

NGS:

Not f

or us

e in h

uman

s. Ke

ep ou

t of r

each

of ch

ildre

n. Av

oid co

ntac

t with

eyes

. In ca

se of

cont

act, i

mmed

iately

flush

eyes

with

co

pious

amou

nts o

f wat

er fo

r 15 m

inute

s. In

case

of de

rmal

cont

act, w

ash

skin

with

soap

and w

ater

. Con

sult a

phys

ician

if irr

itatio

n per

sists

follo

wing

oc

ular o

r der

mal e

xpos

ures

. Indiv

iduals

with

a his

tory

of hy

pers

ensit

ivity

to

quino

lones

shou

ld av

oid th

is pr

oduc

t. In h

uman

s, th

ere i

s a ris

k of u

ser

phot

osen

sitiza

tion w

ithin

a few

hour

s afte

r exc

essiv

e exp

osur

e to

quino

lones

. If ex

cess

ive ac

ciden

tal e

xpos

ure o

ccur

s, av

oid di

rect

sunli

ght.

For c

usto

mer s

ervic

e, to

obta

in a c

opy o

f the M

ater

ial S

afet

y Dat

a She

et

(MSD

S) or

to re

port

adve

rse r

eact

ions,

call N

orbr

ook a

t 1-8

66-5

91-5

777.

PREC

AUTI

ONS:

The e

ffect

s of e

nrof

loxac

in on

cattle

or sw

ine re

prod

uctiv

e per

form

ance

, pr

egna

ncy a

nd la

ctat

ion ha

ve no

t bee

n ade

quat

ely de

term

ined.

The l

ong-

term

effe

cts o

n arti

cular

joint

carti

lage h

ave n

ot be

en de

term

ined i

n pig

s abo

ve m

arke

t weig

ht.

Subc

utan

eous

injec

tion c

an ca

use a

tran

sient

loca

l tiss

ue re

actio

n tha

t may

re

sult i

n trim

loss

of ed

ible t

issue

at sl

augh

ter.

Enro

flox 1

00 co

ntain

s diffe

rent

excip

ients

than

othe

r enr

oflox

acin

prod

ucts.

Th

e saf

ety a

nd ef

ficac

y of th

is fo

rmula

tion i

n spe

cies o

ther

than

cattle

and

swine

have

not b

een d

eter

mine

d.

Quino

lone-

class

drug

s sho

uld be

used

with

caut

ion in

anim

als w

ith kn

own o

r su

spec

ted C

entra

l Ner

vous

Sys

tem

(CNS

) diso

rder

s. In

such

anim

als,

quino

lones

have

, in ra

re in

stanc

es, b

een a

ssoc

iated

with

CNS

stim

ulatio

n wh

ich m

ay le

ad to

conv

ulsive

seizu

res.

Quino

lone-

class

drug

s hav

e bee

n sh

own t

o pro

duce

eros

ions o

f car

tilage

of w

eight

-bea

ring j

oints

and o

ther

sig

ns of

arth

ropa

thy i

n imm

atur

e anim

als of

vario

us sp

ecies

. See

Anim

al Sa

fety

sect

ion fo

r add

itiona

l info

rmat

ion.

ADVE

RSE R

EACT

IONS

:No

adve

rse r

eact

ions w

ere o

bser

ved d

uring

clini

cal tr

ials.

For a

dditio

nal in

form

ation

abou

t adv

erse

drug

expe

rienc

e rep

ortin

g for

an

imal

drug

s, co

ntac

t FDA

at 1-

888-

FDA-

VETS

or on

line a

t ht

tp://w

ww.fd

a.gov

/Anim

alVet

erina

ry/S

afet

yHea

lth.

MIC

ROBI

OLOG

Y: En

roflo

xacin

is ba

cter

icida

l and

exer

ts its

antib

acte

rial e

ffect

by in

hibitin

g ba

cter

ial D

NA gy

rase

(a ty

pe II

topo

isome

rase

) ther

eby p

reve

nting

DNA

su

perc

oiling

and r

eplic

ation

whic

h lea

ds to

cell d

eath

.1 Enr

oflox

acin

is ac

tive

again

st Gr

am-n

egat

ive an

d Gra

m-po

sitive

bact

eria.

EFFE

CTIV

ENES

S:Ca

ttle:

A to

tal o

f 845

calve

s with

natu

rally

-occ

urrin

g BRD

wer

e tre

ated

with

en

roflo

xacin

injec

tion i

n eigh

t field

trial

s loc

ated

in fiv

e cat

tle-fe

eding

stat

es.

Resp

onse

to tr

eatm

ent w

as co

mpar

ed to

non-

treat

ed co

ntro

ls. S

ingle-

dose

an

d mult

iple-

day t

hera

py re

gimen

s wer

e eva

luate

d. BR

D an

d mor

tality

wer

e sig

nifica

ntly

redu

ced i

n enr

oflox

acin-

treat

ed ca

lves.

No ad

vers

e rea

ction

s we

re re

porte

d in t

reat

ed an

imals

.Th

e effe

ctive

ness

of en

roflo

xacin

injec

tion f

or th

e con

trol o

f res

pirat

ory

disea

se in

cattle

at hi

gh ris

k of d

evelo

ping B

RD w

as ev

aluat

ed in

a six

-loca

tion s

tudy

in th

e U.S

. and

Can

ada.

A to

tal o

f 1,15

0 cro

ssbr

ed be

ef

calve

s at h

igh ris

k of d

evelo

ping B

RD w

ere e

nroll

ed in

the s

tudy

. En

roflo

xacin

injec

tion (

7.5 m

g/kg

BW

) or a

n equ

ivalen

t volu

me of

ster

ile

salin

e was

admi

niste

red a

s a si

ngle

subc

utan

eous

injec

tion w

ithin

two d

ays

afte

r arri

val. C

attle

wer

e obs

erve

d dail

y for

clini

cal s

igns o

f BRD

and w

ere

evalu

ated

for s

ucce

ss on

Day

14 po

st-tre

atme

nt. T

reat

ment

succ

ess i

n the

en

roflo

xacin

injec

tion g

roup

(497

/573,

87.83

%) w

as si

gnific

antly

high

er (P

= 0.0

013)

than

succ

ess i

n the

salin

e con

trol g

roup

(455

/571,

80.92

%). I

n add

ition,

ther

e wer

e mor

e tre

atme

nt su

cces

ses (

n=13

) than

failu

res (

n=3)

in th

e gro

up

of an

imals

posit

ive fo

r M. b

ovis

on D

ay 0

that

wer

e tre

ated

with

enro

floxa

cin

injec

tion.

No pr

oduc

t-rela

ted a

dver

se re

actio

ns w

ere r

epor

ted.

Swin

e: A

tota

l of 5

90 pi

gs w

ere t

reat

ed w

ith en

roflo

xacin

injec

tion o

r sali

ne

in tw

o sep

arat

e nat

ural

infec

tion S

RD fie

ld tri

als. F

or th

e tre

atme

nt of

SRD

, th

e suc

cess

rate

of en

roflo

xacin

-trea

ted p

igs th

at w

ere d

efine

d as “

sick a

nd

febr

ile” (

incre

ased

resp

irato

ry ra

te, la

bore

d or d

yspn

eic br

eath

ing,

depr

esse

d attit

ude a

nd a

rect

al te

mper

atur

e ≥10

4.0°F

) was

stat

istica

lly

signif

icant

ly gr

eate

r tha

n the

succ

ess r

ate o

f sali

ne-tr

eate

d “sic

k and

fe

brile

” pigs

. For

the c

ontro

l of S

RD, m

ean r

ecta

l temp

erat

ure,

morta

lity (o

ne

trial)

and m

orbid

ity w

ere s

tatis

ticall

y sign

ifican

tly lo

wer f

or

enro

floxa

cin-tr

eate

d pigs

in pe

ns co

ntain

ing a

perc

enta

ge of

“sick

and

febr

ile” p

igs co

mpar

ed to

salin

e-tre

ated

pigs

.

TOXI

COLO

GY:

The o

ral L

D50 f

or la

bora

tory

rats

was g

reat

er th

an 50

00 m

g/kg

of bo

dy

weigh

t. Nine

ty-da

y fee

ding s

tudie

s in d

ogs a

nd ra

ts re

veale

d no o

bser

vable

ad

vers

e effe

cts a

t trea

tmen

t rat

es of

3 an

d 40 m

g/kg

resp

ectiv

ely. C

hron

ic stu

dies i

n rat

s and

mice

reve

aled n

o obs

erva

ble ad

vers

e effe

cts a

t 5.3

and

323 m

g/kg

resp

ectiv

ely. T

here

was

no ev

idenc

e of c

arcin

ogen

ic ef

fect

in

labor

ator

y anim

al mo

dels.

A tw

o-ge

nera

tion r

at re

prod

uctio

n stu

dy re

veale

d no

effe

ct w

ith 10

mg/

kg tr

eatm

ents.

No t

erat

ogen

ic ef

fect

s wer

e obs

erve

d in

rabb

its at

dose

s of 2

5 mg/

kg or

in ra

ts at

50 m

g/kg

.

ANIM

AL S

AFET

Y:Ca

ttle:

Safe

ty stu

dies w

ere c

ondu

cted

in fe

eder

calve

s usin

g sing

le do

ses o

f 5,

15, a

nd 25

mg/

kg fo

r 15 c

onse

cutiv

e day

s and

50 m

g/kg

for 5

cons

ecut

ive

days

. No c

linica

l sign

s of to

xicity

wer

e obs

erve

d whe

n a do

se of

5 mg

/kg

was a

dmini

stere

d for

15 da

ys. C

linica

l sign

s of d

epre

ssion

, inco

ordin

ation

, an

d mus

cle fa

scicu

lation

wer

e obs

erve

d in c

alves

whe

n dos

es of

15 or

25

mg/kg

wer

e adm

iniste

red f

or 10

to 15

days

. Clin

ical s

igns o

f dep

ress

ion,

inapp

eten

ce an

d inc

oord

inatio

n wer

e obs

erve

d whe

n a do

se of

50 m

g/kg

wa

s adm

iniste

red f

or 3

days

. No d

rug-

relat

ed ab

norm

alitie

s in c

linica

l pa

tholo

gy pa

rame

ters

wer

e ide

ntifie

d. No

artic

ular c

artila

ge le

sions

wer

e ob

serv

ed af

ter e

xami

natio

n of s

tifle j

oints

from

anim

als ad

minis

tere

d 25

mg/kg

for 1

5 day

s.

A sa

fety

study

was

cond

ucte

d in 2

3-da

y-old

calve

s usin

g dos

es of

5, 15

, and

25

mg/

kg fo

r 15 c

onse

cutiv

e day

s. No

clini

cal s

igns o

f toxic

ity or

chan

ges i

n cli

nical

path

ology

para

mete

rs w

ere o

bser

ved.

No ar

ticula

r car

tilage

lesio

ns

were

obse

rved

in th

e stifl

e join

ts at

any d

ose l

evel

at 2

days

and 9

days

fo

llowi

ng 15

days

of dr

ug ad

minis

tratio

n.

An in

jectio

n site

stud

y con

duct

ed in

feed

er ca

lves d

emon

strat

ed th

at th

e fo

rmula

tion m

ay in

duce

a tra

nsien

t rea

ction

in th

e sub

cuta

neou

s tiss

ue an

d un

derly

ing m

uscle

. No p

ainfu

l resp

onse

s to a

dmini

strat

ion w

ere o

bser

ved.

Swin

e: A

safe

ty stu

dy w

as co

nduc

ted i

n 32 p

igs w

eighin

g app

roxim

ately

57

kg (1

25 lb

) usin

g sing

le do

ses o

f 5, 1

5, or

25 m

g/kg

daily

for 1

5 con

secu

tive

days

. Inc

ident

al lam

enes

s of s

hort

dura

tion w

as ob

serv

ed in

all g

roup

s, inc

luding

the s

aline

-trea

ted c

ontro

ls. M

uscu

loske

letal

stiffn

ess w

as

obse

rved

follo

wing

the 1

5 and

25 m

g/kg

trea

tmen

ts wi

th cl

inica

l sign

s ap

pear

ing du

ring t

he se

cond

wee

k of tr

eatm

ent.

Clini

cal s

igns o

f lame

ness

im

prov

ed af

ter t

reat

ment

ceas

ed an

d mos

t anim

als w

ere c

linica

lly no

rmal

at

necr

opsy

.

A se

cond

stud

y was

cond

ucte

d in t

wo pi

gs w

eighin

g app

roxim

ately

23 kg

(50

lb), tr

eate

d with

50 m

g/kg

for 5

cons

ecut

ive da

ys. T

here

wer

e no c

linica

l sig

ns of

toxic

ity or

path

ologic

al ch

ange

s.

An in

jectio

n site

stud

y con

duct

ed in

pigs

demo

nstra

ted t

hat th

e for

mulat

ion

may i

nduc

e a tr

ansie

nt re

actio

n in t

he su

bcut

aneo

us tis

sue.

No p

ainfu

l re

spon

ses t

o adm

inistr

ation

wer

e obs

erve

d.

STOR

AGE C

ONDI

TION

S:Pr

otec

t from

dire

ct su

nligh

t. Do n

ot re

frige

rate

or fr

eeze

. Sto

re be

low 77

°F

(25°C

). Pre

cipita

tion m

ay oc

cur d

ue to

cold

temp

erat

ure.

To re

disso

lve, w

arm

and t

hen s

hake

the v

ial.

HOW

SUP

PLIE

D:En

roflo

x 100

:10

0 mg/

mL

100 m

L Bot

tle10

0 mg/

mL

250 m

L Bot

tle

REFE

RENC

ES:

1. Ho

oper

, D. C

., Wolf

son,

J. S.

, Quin

olone

Ant

imicr

obial

Age

nts,

2nd e

d, 59

- 75

,1993

.

For c

usto

mer s

ervic

e, to

obta

in a c

opy o

f the M

ater

ial S

afet

y Dat

a She

et

(MSD

S) or

to re

port

adve

rse r

eact

ions,

call N

orbr

ook a

t 1-8

66-5

91-5

777.

Restr

icte

d Dru

g - C

alifo

rnia

. Use

Onl

y as D

irect

ed.

Mad

e in t

he U

K.

The N

orbr

ook l

ogos

and E

nrof

lox®

are r

egist

ered

trad

emar

ks

of N

orbr

ook L

abor

ator

ies Li

mite

d.

Norb

rook

Labo

rato

ries L

imite

dNe

wry,

BT35

6PU,

Co.

Down

,No

rther

n Ire

land

Mar

ch 20

15

Enro

flox®

100

(enr

oflo

xaci

n)10

0 m

g/m

L A

ntim

icro

bial

Inje

ctab

le S

olut

ion

TAKE

TIM

E

OBSE

RVE

LABE

LDI

RECT

ION

S

NN F

O

COO

H

CH3C

H2

N

1016

70I0

1

Cu

sto

mer

......

......

......

....

No

rbro

ok

Co

un

try.

......

......

......

......

US

AP

rod

uct

......

......

......

......

. E

nro

flox

100

Co

mp

on

ent

......

......

......

Inse

rtR

eso

urc

e C

od

e...

......

....

6405

1016

70R

evis

ion

Lev

el...

......

.....

I01

Ph

arm

a C

od

e....

......

......

240

4S

ize

......

......

......

......

......

. A5

Dim

ensi

on

s...

......

......

... 1

48 x

210

mm

Key

line

(Die

) R

ef..

......

.. N

/A

CO

LOU

RS

US

ED

:P

MS

Blu

e 07

2

PM

S B

lack

Art

wor

k Sp

ecifi

catio

n fo

r NO

RBRO

OK

PRIN

T RO

OM

from

Gar

eth

Gill

espi

e (2

4/04

/201

5)

TIN

T O

F C

OLO

UR

US

ED

:N

orb

roo

k La

bo

rato

ries

Lim

ited

New

ry, B

T35

6Q

Q, N

ort

her

n Ir

elan

d Te

l: +4

4 (0

)28

3026

4435

(Ex

t: 32

78)

Em

ail:

gare

th.g

illes

pie

@n

orb

roo

k.co

.uk

Web

: ww

w.n

orb

roo

k.co

m

AP

PR

OV

ED

AR

TW

OR

K S

EN

T T

O P

RIN

T B

Y:

Des

ign

er:

Dat

e:

Gar

eth

Gill

esp

ie

23/0

4/20

15

ANAD

A 20

0-49

5, A

ppro

ved

by F

DA

For S

ubcu

tane

ous U

se in

Bee

f Cat

tle, N

on-L

acta

ting D

airy

Cat

tle an

d Sw

ine O

nly.

Not f

or U

se in

Fema

le D

airy

Cat

tle 20

Mon

ths o

f Age

or O

lder

Or I

n Cal

ves

To B

e Pro

cess

ed Fo

r Vea

l.

CAUT

ION:

Fede

ral (U

.S.A

.) law

restr

icts t

his dr

ug to

use b

y or o

n the

orde

r of a

lic

ense

d vet

erina

rian.

Fede

ral (U

.S.A

.) law

proh

ibits

the e

xtra-

label

use o

f this

drug

in

food

-pro

ducin

g anim

als.

PROD

UCT D

ESCR

IPTI

ON:

Enro

flox®

100 i

s a st

erile

, read

y-to

-use

injec

table

antim

icrob

ial so

lution

that

co

ntain

s enr

oflox

acin,

a br

oad-

spec

trum

fluor

oquin

olone

antim

icrob

ial

agen

t.Ea

ch m

L of E

nrof

lox 10

0 con

tains

100 m

g of e

nrof

loxac

in. Ex

cipien

ts ar

e L-

argin

ine ba

se 20

0 mg,

n-bu

tyl al

coho

l 30 m

g, be

nzyl

alcoh

ol (a

s a

pres

erva

tive)

20 m

g and

wat

er fo

r injec

tion q

.s.

CHEM

ICAL

NOM

ENCL

ATUR

E AND

STR

UCTU

RE:

1-cy

clopr

opyl-

7-(4-

ethy

l-1-p

ipera

zinyl)

-6-fl

uoro

-1,

4-dih

ydro

-4-o

xo-3

-quin

oline

carb

oxyli

c acid

.

INDI

CATI

ONS:

Cattl

e - S

ingl

e-Do

se Th

erap

y: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t of

bovin

e res

pirat

ory d

iseas

e (BR

D) as

socia

ted w

ith M

annh

eimia

haem

olytic

a, Pa

steur

ella m

ultoc

ida, H

istop

hilus

somn

i and

Myc

oplas

ma

bovis

in be

ef an

d non

-lact

ating

dairy

cattle

; and

for t

he co

ntro

l of B

RD in

be

ef an

d non

-lact

ating

dairy

cattle

at hi

gh ris

k of d

evelo

ping B

RD

asso

ciate

d with

M. h

aemo

lytica

, P. m

ultoc

ida, H

. som

ni an

d M. b

ovis.

Cattl

e - M

ultip

le-D

ay Th

erap

y: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t of

bovin

e res

pirat

ory d

iseas

e (BR

D) as

socia

ted w

ith M

annh

eimia

haem

olytic

a, Pa

steur

ella m

ultoc

ida an

d Hist

ophil

us so

mni in

beef

and

non-

lacta

ting d

airy c

attle

.

Swin

e: En

roflo

x 100

is in

dicat

ed fo

r the

trea

tmen

t and

cont

rol o

f swi

ne

resp

irato

ry di

seas

e (SR

D) as

socia

ted w

ith A

ctino

bacil

lus

pleur

opne

umon

iae, P

aste

urell

a mult

ocida

, Hae

moph

ilus p

aras

uis an

d St

rept

ococ

cus s

uis.

DOSA

GE A

ND A

DMIN

ISTR

ATIO

N:En

roflo

x 100

prov

ides f

lexibl

e dos

ages

and d

urat

ions o

f ther

apy.

Enro

flox 1

00 m

ay be

admi

niste

red a

s a si

ngle

dose

for o

ne da

y for

tre

atme

nt an

d con

trol o

f BRD

(cat

tle) a

nd S

RD (s

wine

), or f

or m

ultipl

e day

s fo

r BRD

trea

tmen

t (cat

tle). S

elect

ion of

the a

ppro

priat

e dos

e and

dura

tion

of th

erap

y for

BRD

trea

tmen

t in ca

ttle sh

ould

be ba

sed o

n an a

sses

smen

t of

the s

ever

ity of

the d

iseas

e, pa

thog

en su

scep

tibilit

y and

clini

cal

resp

onse

.

Cattl

e:Si

ngle

-Dos

e The

rapy

(BRD

Trea

tmen

t): A

dmini

ster, b

y sub

cuta

neou

s inj

ectio

n, a s

ingle

dose

of 7.

5-12

.5 mg

/kg of

body

weig

ht (3

.4-5.7

mL/1

00 lb

).

Mul

tiple

-Day

Ther

apy (

BRD

Trea

tmen

t): A

dmini

ster d

aily,

a sub

cuta

neou

s

dose

of 2.

5-5 m

g/kg

of bo

dy w

eight

(1.1-

2.3 m

L/100

lb). T

reat

ment

shou

ld be

re

peat

ed at

24-h

our in

terv

als fo

r thr

ee da

ys. A

dditio

nal tr

eatm

ents

may b

e giv

en on

Day

s 4 an

d 5 to

anim

als th

at ha

ve sh

own c

linica

l impr

ovem

ent b

ut

not to

tal re

cove

ry.

Sing

le-D

ose T

hera

py (B

RD C

ontro

l): A

dmini

ster, b

y sub

cuta

neou

s inj

ectio

n, a s

ingle

dose

of 7.

5 mg/

kg of

body

weig

ht (3

.4 mL

/100 l

b).

Exam

ples o

f con

dition

s tha

t may

cont

ribut

e to c

alves

being

at hi

gh ris

k for

de

velop

ing B

RD in

clude

, but

are n

ot lim

ited t

o, th

e foll

owing

:• T

rans

porta

tion w

ith an

imals

from

two o

r mor

e far

m or

igins

.• A

n exte

nded

tran

spor

t time

with

few

to no

rest

stops

.• A

n env

ironm

enta

l temp

erat

ure c

hang

e of ≥

30°F

durin

g tra

nspo

rtatio

n.• A

≥30

°F ra

nge i

n tem

pera

ture

fluct

uatio

n with

in a 2

4-ho

ur pe

riod.

• Exp

osur

e to w

et or

cold

weat

her c

ondit

ions.

• Exc

essiv

e shr

ink (m

ore t

han w

ould

be ex

pect

ed w

ith a

norm

al loa

d of

cattle

).• S

tress

ful a

rriva

l pro

cess

ing pr

oced

ures

(e.g.

castr

ation

or de

horn

ing).

• Exp

osur

e with

in th

e prio

r 72 h

ours

to an

imals

show

ing cl

inica

l sign

s of

BRD.

Admi

niste

red d

ose v

olume

shou

ld no

t exc

eed 2

0 mL p

er in

jectio

n site

.

Tabl

e 1 –

Enro

flox 1

00 D

ose a

nd Tr

eatm

ent S

ched

ule f

or C

attle

*

Tr

eatm

ent

Cont

rol

Sing

le-D

ose

Mul

tiple

-Day

Si

ngle

-Dos

e

Th

erap

y Th

erap

y Th

erap

y

7.5

- 12

.5 mg

/kg

2.5 -

5.0 m

g/kg

7.5

mg/

kg

WEI

GHT

Dose

Volu

me

Dose

Volu

me

Dose

Volu

me

(lb)

(mL)

(mL)

(mL)

10

0 3.5

- 5.5

1.5 - 2

.0 3.5

20

0 7.0

- 11.0

2.5

- 4.5

7.0

300

10.5

- 17.0

3.5

- 6.5

10.5

40

0 14

.0 - 2

2.5

4.5 - 9

.0 14

.0

500

17.0

- 28.5

5.5

- 11.5

17

.0

600

20.5

- 34.0

7.0

- 13.5

20

.5

700

24.0

- 39.5

8.0

- 16.0

24

.0

800

27.5

- 45.5

9.0

- 18.0

27

.5

900

31.0

- 51.0

10

.0 - 2

0.5

31.0

10

00

34.0

- 57.0

11

.0 - 2

3.0

34.0

11

00

37.5

- 62.5

12

.5 - 2

5.0

37.5

*Dos

e volu

mes h

ave b

een r

ound

ed to

the n

eare

st 0.5

mL w

ithin

the d

ose

rang

e.

Swin

e:Ad

minis

ter, b

y sub

cuta

neou

s (be

hind t

he ea

r) inj

ectio

n, a s

ingle

dose

of 7.

5 mg

/kg of

body

weig

ht (3

.4 mL

/100 l

b).

Admi

niste

red d

ose v

olume

shou

ld no

t exc

eed 5

mL p

er in

jectio

n site

.

Tabl

e 2 –

Enro

flox 1

00 D

ose a

nd Tr

eatm

ent S

ched

ule f

or S

win

e

W

EIGH

T (lb

) Do

se Vo

lume

(mL)

50

1.7

10

0 3.4

15

0 5.1

20

0 6.8

25

0 8.5

RESI

DUE W

ARNI

NGS:

Cattl

e: A

nimals

inte

nded

for h

uman

cons

umpt

ion m

ust n

ot be

sla

ught

ered

with

in 28

days

from

the l

ast tr

eatm

ent. T

his pr

oduc

t is

not a

ppro

ved f

or fe

male

dairy

cattle

20 m

onth

s of a

ge or

olde

r, inc

luding

dry d

airy c

ows.

Use i

n the

se ca

ttle m

ay ca

use d

rug

resid

ues i

n milk

and/

or in

calve

s bor

n to t

hese

cows

. A w

ithdr

awal

perio

d has

not b

een e

stabli

shed

for t

his pr

oduc

t in pr

e-ru

mina

ting

calve

s. Do

not u

se in

calve

s to b

e pro

cess

ed fo

r vea

l.Sw

ine:

Anim

als in

tend

ed fo

r hum

an co

nsum

ption

mus

t not

be

slaug

hter

ed w

ithin

5 day

s of r

eceiv

ing a

single

-injec

tion d

ose.

HUM

AN W

ARNI

NGS:

Not f

or us

e in h

uman

s. Ke

ep ou

t of r

each

of ch

ildre

n. Av

oid co

ntac

t with

eyes

. In ca

se of

cont

act, i

mmed

iately

flush

eyes

with

co

pious

amou

nts o

f wat

er fo

r 15 m

inute

s. In

case

of de

rmal

cont

act, w

ash

skin

with

soap

and w

ater

. Con

sult a

phys

ician

if irr

itatio

n per

sists

follo

wing

oc

ular o

r der

mal e

xpos

ures

. Indiv

iduals

with

a his

tory

of hy

pers

ensit

ivity

to

quino

lones

shou

ld av

oid th

is pr

oduc

t. In h

uman

s, th

ere i

s a ris

k of u

ser

phot

osen

sitiza

tion w

ithin

a few

hour

s afte

r exc

essiv

e exp

osur

e to

quino

lones

. If ex

cess

ive ac

ciden

tal e

xpos

ure o

ccur

s, av

oid di

rect

sunli

ght.

For c

usto

mer s

ervic

e, to

obta

in a c

opy o

f the M

ater

ial S

afet

y Dat

a She

et

(MSD

S) or

to re

port

adve

rse r

eact

ions,

call N

orbr

ook a

t 1-8

66-5

91-5

777.

PREC

AUTI

ONS:

The e

ffect

s of e

nrof

loxac

in on

cattle

or sw

ine re

prod

uctiv

e per

form

ance

, pr

egna

ncy a

nd la

ctat

ion ha

ve no

t bee

n ade

quat

ely de

term

ined.

The l

ong-

term

effe

cts o

n arti

cular

joint

carti

lage h

ave n

ot be

en de

term

ined i

n pig

s abo

ve m

arke

t weig

ht.

Subc

utan

eous

injec

tion c

an ca

use a

tran

sient

loca

l tiss

ue re

actio

n tha

t may

re

sult i

n trim

loss

of ed

ible t

issue

at sl

augh

ter.

Enro

flox 1

00 co

ntain

s diffe

rent

excip

ients

than

othe

r enr

oflox

acin

prod

ucts.

Th

e saf

ety a

nd ef

ficac

y of th

is fo

rmula

tion i

n spe

cies o

ther

than

cattle

and

swine

have

not b

een d

eter

mine

d.

Quino

lone-

class

drug

s sho

uld be

used

with

caut

ion in

anim

als w

ith kn

own o

r su

spec

ted C

entra

l Ner

vous

Sys

tem

(CNS

) diso

rder

s. In

such

anim

als,

quino

lones

have

, in ra

re in

stanc

es, b

een a

ssoc

iated

with

CNS

stim

ulatio

n wh

ich m

ay le

ad to

conv

ulsive

seizu

res.

Quino

lone-

class

drug

s hav

e bee

n sh

own t

o pro

duce

eros

ions o

f car

tilage

of w

eight

-bea

ring j

oints

and o

ther

sig

ns of

arth

ropa

thy i

n imm

atur

e anim

als of

vario

us sp

ecies

. See

Anim

al Sa

fety

sect

ion fo

r add

itiona

l info

rmat

ion.

ADVE

RSE R

EACT

IONS

:No

adve

rse r

eact

ions w

ere o

bser

ved d

uring

clini

cal tr

ials.

For a

dditio

nal in

form

ation

abou

t adv

erse

drug

expe

rienc

e rep

ortin

g for

an

imal

drug

s, co

ntac

t FDA

at 1-

888-

FDA-

VETS

or on

line a

t ht

tp://w

ww.fd

a.gov

/Anim

alVet

erina

ry/S

afet

yHea

lth.

MIC

ROBI

OLOG

Y: En

roflo

xacin

is ba

cter

icida

l and

exer

ts its

antib

acte

rial e

ffect

by in

hibitin

g ba

cter

ial D

NA gy

rase

(a ty

pe II

topo

isome

rase

) ther

eby p

reve

nting

DNA

su

perc

oiling

and r

eplic

ation

whic

h lea

ds to

cell d

eath

.1 Enr

oflox

acin

is ac

tive

again

st Gr

am-n

egat

ive an

d Gra

m-po

sitive

bact

eria.

EFFE

CTIV

ENES

S:Ca

ttle:

A to

tal o

f 845

calve

s with

natu

rally

-occ

urrin

g BRD

wer

e tre

ated

with

en

roflo

xacin

injec

tion i

n eigh

t field

trial

s loc

ated

in fiv

e cat

tle-fe

eding

stat

es.

Resp

onse

to tr

eatm

ent w

as co

mpar

ed to

non-

treat

ed co

ntro

ls. S

ingle-

dose

an

d mult

iple-

day t

hera

py re

gimen

s wer

e eva

luate

d. BR

D an

d mor

tality

wer

e sig

nifica

ntly

redu

ced i

n enr

oflox

acin-

treat

ed ca

lves.

No ad

vers

e rea

ction

s we

re re

porte

d in t

reat

ed an

imals

.Th

e effe

ctive

ness

of en

roflo

xacin

injec

tion f

or th

e con

trol o

f res

pirat

ory

disea

se in

cattle

at hi

gh ris

k of d

evelo

ping B

RD w

as ev

aluat

ed in

a six

-loca

tion s

tudy

in th

e U.S

. and

Can

ada.

A to

tal o

f 1,15

0 cro

ssbr

ed be

ef

calve

s at h

igh ris

k of d

evelo

ping B

RD w

ere e

nroll

ed in

the s

tudy

. En

roflo

xacin

injec

tion (

7.5 m

g/kg

BW

) or a

n equ

ivalen

t volu

me of

ster

ile

salin

e was

admi

niste

red a

s a si

ngle

subc

utan

eous

injec

tion w

ithin

two d

ays

afte

r arri

val. C

attle

wer

e obs

erve

d dail

y for

clini

cal s

igns o

f BRD

and w

ere

evalu

ated

for s

ucce

ss on

Day

14 po

st-tre

atme

nt. T

reat

ment

succ

ess i

n the

en

roflo

xacin

injec

tion g

roup

(497

/573,

87.83

%) w

as si

gnific

antly

high

er (P

= 0.0

013)

than

succ

ess i

n the

salin

e con

trol g

roup

(455

/571,

80.92

%). I

n add

ition,

ther

e wer

e mor

e tre

atme

nt su

cces

ses (

n=13

) than

failu

res (

n=3)

in th

e gro

up

of an

imals

posit

ive fo

r M. b

ovis

on D

ay 0

that

wer

e tre

ated

with

enro

floxa

cin

injec

tion.

No pr

oduc

t-rela

ted a

dver

se re

actio

ns w

ere r

epor

ted.

Swin

e: A

tota

l of 5

90 pi

gs w

ere t

reat

ed w

ith en

roflo

xacin

injec

tion o

r sali

ne

in tw

o sep

arat

e nat

ural

infec

tion S

RD fie

ld tri

als. F

or th

e tre

atme

nt of

SRD

, th

e suc

cess

rate

of en

roflo

xacin

-trea

ted p

igs th

at w

ere d

efine

d as “

sick a

nd

febr

ile” (

incre

ased

resp

irato

ry ra

te, la

bore

d or d

yspn

eic br

eath

ing,

depr

esse

d attit

ude a

nd a

rect

al te

mper

atur

e ≥10

4.0°F

) was

stat

istica

lly

signif

icant

ly gr

eate

r tha

n the

succ

ess r

ate o

f sali

ne-tr

eate

d “sic

k and

fe

brile

” pigs

. For

the c

ontro

l of S

RD, m

ean r

ecta

l temp

erat

ure,

morta

lity (o

ne

trial)

and m

orbid

ity w

ere s

tatis

ticall

y sign

ifican

tly lo

wer f

or

enro

floxa

cin-tr

eate

d pigs

in pe

ns co

ntain

ing a

perc

enta

ge of

“sick

and

febr

ile” p

igs co

mpar

ed to

salin

e-tre

ated

pigs

.

TOXI

COLO

GY:

The o

ral L

D50 f

or la

bora

tory

rats

was g

reat

er th

an 50

00 m

g/kg

of bo

dy

weigh

t. Nine

ty-da

y fee

ding s

tudie

s in d

ogs a

nd ra

ts re

veale

d no o

bser

vable

ad

vers

e effe

cts a

t trea

tmen

t rat

es of

3 an

d 40 m

g/kg

resp

ectiv

ely. C

hron

ic stu

dies i

n rat

s and

mice

reve

aled n

o obs

erva

ble ad

vers

e effe

cts a

t 5.3

and

323 m

g/kg

resp

ectiv

ely. T

here

was

no ev

idenc

e of c

arcin

ogen

ic ef

fect

in

labor

ator

y anim

al mo

dels.

A tw

o-ge

nera

tion r

at re

prod

uctio

n stu

dy re

veale

d no

effe

ct w

ith 10

mg/

kg tr

eatm

ents.

No t

erat

ogen

ic ef

fect

s wer

e obs

erve

d in

rabb

its at

dose

s of 2

5 mg/

kg or

in ra

ts at

50 m

g/kg

.

ANIM

AL S

AFET

Y:Ca

ttle:

Safe

ty stu

dies w

ere c

ondu

cted

in fe

eder

calve

s usin

g sing

le do

ses o

f 5,

15, a

nd 25

mg/

kg fo

r 15 c

onse

cutiv

e day

s and

50 m

g/kg

for 5

cons

ecut

ive

days

. No c

linica

l sign

s of to

xicity

wer

e obs

erve

d whe

n a do

se of

5 mg

/kg

was a

dmini

stere

d for

15 da

ys. C

linica

l sign

s of d

epre

ssion

, inco

ordin

ation

, an

d mus

cle fa

scicu

lation

wer

e obs

erve

d in c

alves

whe

n dos

es of

15 or

25

mg/kg

wer

e adm

iniste

red f

or 10

to 15

days

. Clin

ical s

igns o

f dep

ress

ion,

inapp

eten

ce an

d inc

oord

inatio

n wer

e obs

erve

d whe

n a do

se of

50 m

g/kg

wa

s adm

iniste

red f

or 3

days

. No d

rug-

relat

ed ab

norm

alitie

s in c

linica

l pa

tholo

gy pa

rame

ters

wer

e ide

ntifie

d. No

artic

ular c

artila

ge le

sions

wer

e ob

serv

ed af

ter e

xami

natio

n of s

tifle j

oints

from

anim

als ad

minis

tere

d 25

mg/kg

for 1

5 day

s.

A sa

fety

study

was

cond

ucte

d in 2

3-da

y-old

calve

s usin

g dos

es of

5, 15

, and

25

mg/

kg fo

r 15 c

onse

cutiv

e day

s. No

clini

cal s

igns o

f toxic

ity or

chan

ges i

n cli

nical

path

ology

para

mete

rs w

ere o

bser

ved.

No ar

ticula

r car

tilage

lesio

ns

were

obse

rved

in th

e stifl

e join

ts at

any d

ose l

evel

at 2

days

and 9

days

fo

llowi

ng 15

days

of dr

ug ad

minis

tratio

n.

An in

jectio

n site

stud

y con

duct

ed in

feed

er ca

lves d

emon

strat

ed th

at th

e fo

rmula

tion m

ay in

duce

a tra

nsien

t rea

ction

in th

e sub

cuta

neou

s tiss

ue an

d un

derly

ing m

uscle

. No p

ainfu

l resp

onse

s to a

dmini

strat

ion w

ere o

bser

ved.

Swin

e: A

safe

ty stu

dy w

as co

nduc

ted i

n 32 p

igs w

eighin

g app

roxim

ately

57

kg (1

25 lb

) usin

g sing

le do

ses o

f 5, 1

5, or

25 m

g/kg

daily

for 1

5 con

secu

tive

days

. Inc

ident

al lam

enes

s of s

hort

dura

tion w

as ob

serv

ed in

all g

roup

s, inc

luding

the s

aline

-trea

ted c

ontro

ls. M

uscu

loske

letal

stiffn

ess w

as

obse

rved

follo

wing

the 1

5 and

25 m

g/kg

trea

tmen

ts wi

th cl

inica

l sign

s ap

pear

ing du

ring t

he se

cond

wee

k of tr

eatm

ent.

Clini

cal s

igns o

f lame

ness

im

prov

ed af

ter t

reat

ment

ceas

ed an

d mos

t anim

als w

ere c

linica

lly no

rmal

at

necr

opsy

.

A se

cond

stud

y was

cond

ucte

d in t

wo pi

gs w

eighin

g app

roxim

ately

23 kg

(50

lb), tr

eate

d with

50 m

g/kg

for 5

cons

ecut

ive da

ys. T

here

wer

e no c

linica

l sig

ns of

toxic

ity or

path

ologic

al ch

ange

s.

An in

jectio

n site

stud

y con

duct

ed in

pigs

demo

nstra

ted t

hat th

e for

mulat

ion

may i

nduc

e a tr

ansie

nt re

actio

n in t

he su

bcut

aneo

us tis

sue.

No p

ainfu

l re

spon

ses t

o adm

inistr

ation

wer

e obs

erve

d.

STOR

AGE C

ONDI

TION

S:Pr

otec

t from

dire

ct su

nligh

t. Do n

ot re

frige

rate

or fr

eeze

. Sto

re be

low 77

°F

(25°C

). Pre

cipita

tion m

ay oc

cur d

ue to

cold

temp

erat

ure.

To re

disso

lve, w

arm

and t

hen s

hake

the v

ial.

HOW

SUP

PLIE

D:En

roflo

x 100

:10

0 mg/

mL

100 m

L Bot

tle10

0 mg/

mL

250 m

L Bot

tle

REFE

RENC

ES:

1. Ho

oper

, D. C

., Wolf

son,

J. S.

, Quin

olone

Ant

imicr

obial

Age

nts,

2nd e

d, 59

- 75

,1993

.

For c

usto

mer s

ervic

e, to

obta

in a c

opy o

f the M

ater

ial S

afet

y Dat

a She

et

(MSD

S) or

to re

port

adve

rse r

eact

ions,

call N

orbr

ook a

t 1-8

66-5

91-5

777.

Restr

icte

d Dru

g - C

alifo

rnia

. Use

Onl

y as D

irect

ed.

Mad

e in t

he U

K.

The N

orbr

ook l

ogos

and E

nrof

lox®

are r

egist

ered

trad

emar

ks

of N

orbr

ook L

abor

ator

ies Li

mite

d.

Norb

rook

Labo

rato

ries L

imite

dNe

wry,

BT35

6PU,

Co.

Down

,No

rther

n Ire

land

Mar

ch 20

15

Enro

flox®

100

(enr

oflo

xaci

n)10

0 m

g/m

L A

ntim

icro

bial

Inje

ctab

le S

olut

ion

TAKE

TIM

E

OBSE

RVE

LABE

LDI

RECT

ION

S

NN F

O

COO

H

CH3C

H2

N

1016

70I0

1

Cu

sto

mer

......

......

......

....

No

rbro

ok

Co

un

try.

......

......

......

......

US

AP

rod

uct

......

......

......

......

. E

nro

flox

100

Co

mp

on

ent

......

......

......

Inse

rtR

eso

urc

e C

od

e...

......

....

6405

1016

70R

evis

ion

Lev

el...

......

.....

I01

Ph

arm

a C

od

e....

......

......

240

4S

ize

......

......

......

......

......

. A5

Dim

ensi

on

s...

......

......

... 1

48 x

210

mm

Key

line

(Die

) R

ef..

......

.. N

/A

CO

LOU

RS

US

ED

:P

MS

Blu

e 07

2

PM

S B

lack

Art

wor

k Sp

ecifi

catio

n fo

r NO

RBRO

OK

PRIN

T RO

OM

from

Gar

eth

Gill

espi

e (2

4/04

/201

5)

TIN

T O

F C

OLO

UR

US

ED

:N

orb

roo

k La

bo

rato

ries

Lim

ited

New

ry, B

T35

6Q

Q, N

ort

her

n Ir

elan

d Te

l: +4

4 (0

)28

3026

4435

(Ex

t: 32

78)

Em

ail:

gare

th.g

illes

pie

@n

orb

roo

k.co

.uk

Web

: ww

w.n

orb

roo

k.co

m

AP

PR

OV

ED

AR

TW

OR

K S

EN

T T

O P

RIN

T B

Y:

Des

ign

er:

Dat

e:

Gar

eth

Gill

esp

ie

23/0

4/20

15

0815-495-I01G