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ZOETIS DRY COW TUBES STAND UP TO THE COMPETITION. BRAND SPECTRAMAST ® DC* (ceftiofur hydrochloride) Sterile Suspension ALBADRY PLUS ® (penicillin G procaine and novobiocin sodium) Suspension ToMORROW ® Cefa-Dri ® (cephapirin benzathine) Orbenin ® -DC (benzathine cloxacillin) Dry-Clox ® (benzathine cloxacillin) ACTIVE INGREDIENT Ceftiofur 500 mg Penicillin 200,000 IU and novobiocin 400 mg Cephapirin 300 mg Cloxacillin 500 mg Cloxacillin 500 mg INDICATIONS Treatment Treatment of subclinical mastitis Treatment of mastitis Treatment and prophylaxis of mastitis Treatment of mastitis LABELED PATHOGENS Staph. aureus Strep. dysgalactiae Strep. uberis Staph. aureus Strep. agalactiae Staph. aureus Strep. agalactiae Staph. aureus Strep. agalactiae Staph. aureus Strep. agalactiae PRE-SLAUGHTER WITHDRAWAL* 16 days 30 days 42 days 28 days 30 days MILK DISCARD** 0 hours 72 hours 72 hours 0 hours 0 hours DRY PERIOD LENGTH 30 days 30 days 30 days 28 days 30 days AVAILABILITY R x OTC OTC R x R x YEAR INTRODUCED 2005 1983 1978 1975 1975 *After last administration (or treatment) **Milk discard times begin at first milking post freshening and require completion of a minimum dry cow period. DRY COW | MILK QUALITY ***Zero milk discard period after calving following a 30-day dry cow period. KEY FEATURES: Unique combination of penicillin and novobiocin provides reliable therapy for subclinical mastitis in dry cows Has a synergistic effect on bacterial isolates from bovine intramammary infections 1 Bactericidal activity against the two common mastitis- causing pathogens — Staph. aureus and Strep. agalactiae Helps eliminate single-antibiotic failures and reduces the likelihood of resistance KEY FEATURES: Attacks more major mastitis-causing pathogens, including Staphylococcus aureus, Streptococcus dysgalactiae and Strep. uberis Shortest meat withdrawal — allows you to maximize your management options Zero milk discard*** — so you can get them back in the milking string faster Greater flexibility in milk and cattle management decisions Important Safety Information: Inappropriate dosage or treatment intervals with SPECTRAMAST DC and/or failure to complete a minimum dry cow period (30 days) may result in violative milk residues. In cows completing a 30-day dry cow period, no milk discard is necessary. Following treatment with SPECTRAMAST DC, a 16-day pre-slaughter withdrawal is required. As with all drugs, SPECTRAMAST DC should not be used in animals found to be hypersensitive to the product. 1 Wheeler SJ, Edmondson PW, et al. Effect of Penicillin/Novobiocin (TETRADELTA Dry Cow, ALBADRY PLUS ® Sterile Suspension) Dry Cow Therapy on Somatic Cell Count of Dairy Cows Over the Dry Period. Proc International Buiatrics Congress 2000. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2013 Zoetis Inc. All rights reserved. GDR13164 Important Safety Information: Do not use ALBADRY PLUS less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days following udder infusion. See full Prescribing Information attached.
2

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Page 1: MiLk QUALiTY ZOETIS DRY COW TUBES STAND UP TO · PDF fileZOETIS DRY COW TUBES STAND UP TO THE COMPETITION. ... mastitis Treatment of mastitis ... no pre-slaughter withdrawal period

ZOETIS DRY COW TUBESSTAND UP TO THE COMPETITION.

BRAND SPECTRAMAST® DC* (ceftiofur hydrochloride)

Sterile Suspension

ALBADRY PLUS®

(penicillin G procaine and novobiocin sodium)

Suspension

ToMORROW®

Cefa-Dri®

(cephapirin benzathine)

Orbenin®-DC (benzathine cloxacillin)

Dry-Clox®

(benzathine cloxacillin)

ACTivE iNgREDiENT Ceftiofur

500 mgPenicillin 200,000 IU and

novobiocin 400 mg

Cephapirin 300 mg

Cloxacillin 500 mg

Cloxacillin 500 mg

iNDiCATiONS TreatmentTreatment

of subclinical mastitis

Treatment of mastitis

Treatment and prophylaxisof mastitis

Treatmentof mastitis

LABELED PAThOgENS Staph. aureus

Strep. dysgalactiaeStrep. uberis

Staph. aureusStrep. agalactiae

Staph. aureusStrep. agalactiae

Staph. aureusStrep. agalactiae

Staph. aureusStrep. agalactiae

PRE-SLAUghTER WiThDRAWAL*

16 days 30 days 42 days 28 days 30 days

MiLk DiSCARD** 0 hours 72 hours 72 hours 0 hours 0 hours

DRY PERiOD LENgTh

30 days 30 days 30 days 28 days 30 days

AvAiLABiLiTY Rx OTC OTC Rx Rx

YEARiNTRODUCED

2005 1983 1978 1975 1975

*After last administration (or treatment)**Milk discard times begin at first milking post freshening and require completion of a minimum dry cow period.

DRY COW | MiLk QUALiTY

***Zero milk discard period after calving following a 30-day dry cow period.

kEY FEATURES:• Unique combination of penicillin and novobiocin provides

reliable therapy for subclinical mastitis in dry cows• Has a synergistic effect on bacterial isolates from bovine

intramammary infections1

• Bactericidal activity against the two common mastitis- causing pathogens — Staph. aureus and Strep. agalactiae

• Helps eliminate single-antibiotic failures and reduces the likelihood of resistance

kEY FEATURES:• Attacks more major mastitis-causing pathogens, including

Staphylococcus aureus, Streptococcus dysgalactiae and Strep. uberis

• Shortest meat withdrawal — allows you to maximize your management options• Zero milk discard*** — so you can get them back in the

milking string faster• Greater flexibility in milk and cattle management decisions

important Safety information: Inappropriate dosage or treatment intervals with SPECTRAMAST DC and/or failure to complete a minimum dry cow period (30 days) may result in violative milk residues. In cows completing a 30-day dry cow period, no milk discard is necessary. Following treatment with SPECTRAMAST DC, a 16-day pre-slaughter withdrawal is required. As with all drugs, SPECTRAMAST DC should not be used in animals found to be hypersensitive to the product.

1 Wheeler SJ, Edmondson PW, et al. Effect of Penicillin/Novobiocin (TETRADELTA™ Dry Cow, ALBADRY PLUS® Sterile Suspension) Dry Cow Therapy on Somatic Cell Count of Dairy Cows Over the Dry Period. Proc International Buiatrics Congress 2000. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2013 Zoetis Inc. All rights reserved. GDR13164

important Safety information: Do not use ALBADRY PLUS less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days following udder infusion. See full Prescribing Information attached.

Page 2: MiLk QUALiTY ZOETIS DRY COW TUBES STAND UP TO · PDF fileZOETIS DRY COW TUBES STAND UP TO THE COMPETITION. ... mastitis Treatment of mastitis ... no pre-slaughter withdrawal period

For I

ntr

amam

mar

y In

fusi

on in

Dry

Dai

ry C

attle

Onl

y

FO

R U

SE

IN A

NIM

AL

S O

NLY

— N

OT

FO

R H

UM

AN

US

E

CA

UT

ION

: Fe

dera

l (US

A) la

w re

stric

ts th

is d

rug

to u

se b

y or

on

the

orde

r of

a

licen

sed

vete

rinar

ian.

DE

SC

RIP

TIO

N:

Cefti

ofur

hy

droc

hlor

ide

is

a ce

phal

ospo

rin

antib

iotic

.

Chem

ical

Stru

ctur

e of

Ce

ftiof

ur H

ydro

chlo

ride

Ch

emic

al N

ame

of

C

efti

ofu

r H

ydro

chlo

rid

e5-

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cycl

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min

o]-3

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nylc

arbo

nyl)

thio

]met

hyl]-

8-ox

o,

hydr

ochl

orid

e.

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ftiof

ur

Hydr

ochl

orid

e St

erile

Su

spen

sion

is

an

oi

l-bas

ed

ster

ile s

uspe

nsio

n.

Ea

ch 1

0 m

L PL

ASTE

T® Di

spos

able

Syr

inge

Con

tain

s:

Cefti

ofur

Equ

ival

ents

(as

the

hydr

ochl

orid

e sa

lt) ..

......

......

......

......

......

......

......

.500

mg

Mic

rocr

ysta

lline

Wax

......

......

......

......

......

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......

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......

......

......

...70

0 m

gLa

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l M 1

944

CS ..

......

......

......

......

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......

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......

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0 m

gCo

ttons

eed

Oil ..

......

......

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......

......

......

......

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q.s.

IND

ICA

TIO

NS

FO

R U

SE

SP

EC

TR

AM

AS

DC

Ce

ftiof

ur

Hydr

ochl

orid

e St

erile

Su

s-pe

nsio

n is

in

dica

ted

for

the

treat

men

t of

su

bclin

ical

m

astit

is

in

dairy

ca

ttle

at

the

time

of

dry

off

asso

ciat

ed

with

S

taph

yloc

occu

s au

reus

, S

trep

toco

ccus

dy

sgal

actia

e, a

nd S

trep

toco

ccus

ub

eris

. S

PE

CT

RA

MA

ST

® D

C C

eftio

fur

Hydr

ochl

orid

e St

erile

Sus

pens

ion

has

been

pr

oven

effe

ctiv

e ag

ains

t Sta

phyl

ococ

cus

aure

us,

Str

epto

cocc

us d

ysga

-la

ctia

e, a

nd S

trep

toco

ccus

ube

ris.

DO

SA

GE

Infu

se o

ne (1

) syr

inge

into

eac

h af

fect

ed q

uarte

r at t

he ti

me

of d

ry o

ff.

DIR

EC

TIO

NS

FO

R U

SIN

G P

LA

ST

ET

® D

ISP

OS

AB

LE

SY

RIN

GE

Th

e sy

ringe

is

de

sign

ed

to

prov

ide

the

choi

ce

of

eith

er

inse

rtion

of

th

e fu

ll ca

nnul

a as

ha

s tra

ditio

nally

be

en

prac

ticed

, or

in

serti

on o

f no

mor

e th

an 1

/8 i

nch

of t

he c

annu

la,

as r

epor

ted

by E

berh

art,

R.J.

, et

. al

. 19

87.

Curre

nt C

once

pts

of B

ovin

e M

astit

is,

3rd

Editi

on,

Natio

nal

Mas

titis

Cou

ncil,

Arli

ngto

n, V

A.

a.

Fu

ll in

sert

ion

: Re

mov

e th

e re

d en

d ca

p by

pul

ling

stra

ight

up

as

show

n.

Gent

ly

inse

rt th

e fu

ll ca

nnul

a in

to

the

teat

ca

nal;

care

fully

infu

se th

e pr

oduc

t.

b.

Par

tial

in

sert

ion

: Re

mov

e th

e re

d en

d ca

p by

pul

ling

stra

ight

up

as

sh

own.

Ge

ntly

in

sert

the

expo

sed

white

tip

in

to

the

teat

ca

nal;

ca

refu

lly in

fuse

the

prod

uct.

AD

MIN

IST

RA

TIO

N

Tr

eatm

ent:

W

ash

teat

s th

orou

ghly

wi

th

warm

wa

ter

cont

aini

ng

a su

itabl

e da

iry

antis

eptic

. Dr

y te

ats

thor

ough

ly.

Milk

ou

t ud

der

com

-pl

etel

y. Us

ing

an

alco

hol

pad

prov

ided

, wi

pe

off

the

end

of

the

affe

c-

ted

teat

us

ing

a se

para

te

pad

for

each

te

at.

Choo

se

the

desi

red

inse

rtion

le

ngth

(fu

ll or

pa

rtial

) an

d in

sert

tip

into

te

at

cana

l; pu

sh

plun

ger

to

disp

ense

en

tire

cont

ents

, m

assa

ge

the

quar

ter

to

dist

ri-

bute

th

e su

spen

sion

in

to

the

milk

ci

ster

n.

Rei

nfe

ctio

n:

After

su

cces

sful

treatm

ent,

rein

fectio

n m

ay

occu

r un

less

good

he

rd

man

agem

ent,

sani

tatio

n,

and

mec

hani

cal

safe

ty

mea

sure

s ar

e pr

actic

ed.

Affe

cted

cow

s sh

ould

be

watc

hed

care

fully

to

dete

ct

recu

rrenc

e of

infe

ctio

n an

d po

ssib

le s

prea

d to

oth

er a

nim

als.

CO

NT

RA

IND

ICA

TIO

NS

As w

ith a

ll dr

ugs,

the

use

of S

PE

CT

RA

MA

ST

® D

C S

teril

e Su

spen

sion

is

cont

rain

dica

ted

in a

nim

als

prev

ious

ly fo

und

to b

e hy

pers

ensi

tive

to th

e dr

ug.

WA

RN

ING

S

Pe

nici

llins

an

d ce

phal

ospo

rins

can

caus

e al

lerg

ic

reac

tions

in

se

n-

sitiz

ed

indi

vidu

als.

To

pica

l ex

posu

res

to

such

an

timic

robi

als,

in

clud

ing

cefti

ofur

, m

ay

elic

it m

ild

to

seve

re

alle

rgic

re

actio

ns

in

som

e in

divi

du-

als.

Re

peat

ed

or

prol

onge

d ex

posu

re

may

le

ad

to

sens

itiza

tion.

Av

oid

dire

ct

cont

act

of

the

prod

uct

with

th

e sk

in,

eyes

, m

outh

an

d cl

othi

ng.

Sens

itiza

tion

of

the

skin

m

ay

be

avoi

ded

by

wear

ing

late

x gl

oves

.Per

sons

wi

th

a kn

own

hype

rsen

sitiv

ity

to

peni

cil-

lin

or

ceph

alos

porin

s sh

ould

av

oid

expo

sure

to

th

is

prod

uct.

In

ca

se

of

acci

dent

al

eye

expo

sure

, flu

sh

with

wa

ter

for

15

min

utes

. In

ca

se

of

acci

dent

al

skin

ex

posu

re,

wash

wi

th

soap

an

d wa

ter.

Rem

ove

cont

amin

ated

cl

othi

ng.

If al

lerg

ic

reac

tion

occu

rs

(e.g

., sk

in

rash

, hiv

es, d

ifficu

lt br

eath

ing)

, see

k m

edic

al a

ttent

ion.

Th

e m

ater

ial

safe

ty

data

sh

eet

cont

ains

m

ore

deta

iled

occu

- pa

tiona

l sa

fety

in

form

atio

n.

To

repo

rt ad

vers

e ef

fect

s in

us

ers,

to

ob

tain

m

ore

info

rmat

ion

or

to

obta

in

a m

ater

ial

safe

ty

data

sh

eet,

call

1-80

0-36

6-52

88.

RE

SID

UE

WA

RN

ING

S

1. M

ilk

take

n fro

m

cows

co

mpl

etin

g a

30-d

ay

dry

cow

pe

riod

may

be

us

ed

for

food

wi

th

no

milk

di

scar

d

due

to c

eftio

fur r

esid

ues.

2. F

ollo

wing

la

bel

use,

no

pr

e-sl

augh

ter

with

draw

al

pe

riod

is

requ

ired

for

neon

atal

ca

lves

bo

rn

from

treate

d co

ws re

gard

less o

f col

ostru

m co

nsum

ptio

n.

3. F

ollo

wing

in

tram

amm

ary

infu

sion

, a

16-d

ay

pre-

slau

ghte

r wi

thdr

awal

pe

riod

is

requ

ired

for

treat

ed

cows

.4.

Use

of

th

is pr

oduc

t in

a

man

ner

othe

r th

an

indi

cated

un

der D

OSAG

E m

ight

resu

lt in

viol

ative

resid

ues.

CL

INIC

AL

MIC

RO

BIO

LO

GY

Cefti

ofur

is

a

broa

d-sp

ectru

m

ceph

alos

porin

an

tibio

tic

that

ex

- er

ts

its

effe

ct

by

inhi

bitin

g ba

cter

ial

cell

wall

synt

hesi

s.

Like

ot

her

ß-la

ctam

an

timic

robi

al

agen

ts,

the

ceph

alos

porin

s in

hibi

t ce

ll wa

ll sy

nthe

sis

by

inte

rferin

g wi

th

the

enzy

mes

es

sent

ial

for

pept

idog

ly-

can

synt

hesi

s.

This

ef

fect

re

sults

in

ly

sis

of

the

bact

eria

l ce

ll an

d ac

coun

ts

for

the

bact

eric

idal

na

ture

of

th

ese

agen

ts.

Cefti

ofur

ha

s de

mon

stra

ted

in

vitr

o ac

tivity

ag

ains

t cl

inic

al

isol

ates

an

d is

o-la

tes

from

di

agno

stic

la

bora

torie

s.

The

resu

lts

of

susc

eptib

il-ity

tes

ting

of t

hese

iso

late

s ag

ains

t ce

ftiof

ur a

re p

rese

nted

in

Tabl

es 1

and

2.

Appr

opria

te re

fere

nce s

train

s wer

e als

o su

scep

tibili

ty te

sted

and

thei

r min

imum

inhi

bi-

tory

con

cent

ratio

n (M

IC) v

alue

s an

d zo

ne o

f inh

ibiti

on w

ith a

30

μg d

isk

are

pres

ente

d in

Tabl

e 4.

Tab

le 1

. Cef

tio

fur

MIC

val

ues

fo

r is

ola

tes

fro

m a

mu

lti-

site

cl

inic

al fi

eld

stu

dy

eval

uat

ing

su

bcl

inic

al m

asti

tis

in

dry

dai

ry c

ow

s in

th

e U

.S. d

uri

ng

200

0

Org

anis

mN

o.

MIC

90*

(μg

/mL

)M

IC r

ang

e(μ

g/m

L)

Sta

phyl

ococ

cus

aure

us30

01.

0≤

0.06

to 2

.0

Str

epto

cocc

us d

ysga

lact

iae

55≤

0.06

≤0.

06 to

>64

.0

Str

epto

cocc

us u

beris

581.

0≤

0.06

to 4

.0

* Th

e M

IC fo

r 90%

of t

he is

olat

es.

Tab

le 2

. Cef

tio

fur

MIC

val

ues

* fo

r m

asti

tis

pat

ho

gen

s

fro

m d

iag

no

stic

lab

ora

tori

es in

th

e U

.S. a

nd

Can

ada

Org

anis

mN

o.

Dat

e is

ola

ted

MIC

90**

(μg

/mL

)M

IC r

ang

e(μ

g/m

L)

Sta

phyl

ococ

cus

aure

us

135

1991

–199

21.

00.

13 to

2.0

1019

931.

00.

25 to

1.0

107

1995

1.0

0.25

to 2

.0

6120

001.

0≤

0.06

to 2

.0Co

agul

ase

(-)

stap

hylo

cocc

i13

920

00–2

001

1.0

≤0.

06 to

2.0

Str

epto

cocc

us

dysg

alac

tiae

1519

91–1

992

1.0

≤0.

06 to

2.0

1519

93≤

0.00

39No

rang

e†

152

1997

–199

90.

250.

25 to

4.0

6420

00≤

0.06

≤0.

06 to

0.5

Str

epto

cocc

us

uber

is

2219

91–1

992

0.5

≤0.

06 to

4.0

1519

930.

03≤0

.003

9 to

0.06

133

1997

–199

90.

50.

5 to

8.0

2020

001.

0<0

.06

to 2

.0

Esc

heric

hia

coli

3919

91–1

992

1.0

0.25

to 1

.0

4019

930.

50.

13 to

1.0

5220

000.

5≤

0.06

to 1

.0

* T

he

abov

e in

vi

tro

data

ar

e av

aila

ble,

bu

t th

eir

clin

ical

si

gnifi

canc

e

is u

nkno

wn.

** T

he M

IC fo

r 90%

of t

he is

olat

es.

† No

rang

e, a

ll is

olat

es y

ield

ed th

e sa

me

valu

e.

Ba

sed

on

phar

mac

okin

etic

, m

ilk

resi

due

and

clin

ical

ef

fect

iven

ess

stud

ies

in d

airy

cat

tle fo

llowi

ng in

tram

amm

ary

infu

sion

of c

eftio

fur a

nd th

e M

IC a

nd

disk

(30

μg)

diff

usio

n da

ta fr

om m

astit

is p

atho

gens

, the

follo

wing

bre

akpo

ints

are

re

com

men

ded

by th

e Cl

inic

al a

nd L

abor

ator

ies

Stan

dard

s In

stitu

te (C

LSI)

(Tab

le 3

).

Tab

le 3

. Cu

rren

t re

com

men

ded

inte

rpre

tive

cri

teri

a

esta

blis

hed

by

CL

SI f

or

ceft

iofu

r fo

r B

ovi

ne

Mas

titi

s

Bo

vin

e M

asti

tis

Org

anis

ms

Dis

k C

on

ten

tZ

on

e d

iam

eter

(m

m)

MIC

bre

akp

oin

t

(μg

/mL

)

SI

RS

IR

Sta

phyl

ococ

cus

aure

us

30 μ

g≥

2118

–20

≤17

≤ 2

.04.

0≥

8.0

Str

epto

cocc

us

dysg

alac

tiae

Str

epto

cocc

us

uber

isS

trep

toco

ccus

ag

alac

tiae

Esc

heric

hia

coli

S –

Susc

eptib

le

I

– In

term

edia

te

R

– R

esis

tant

St

anda

rdize

d pr

oced

ures

re

quire

th

e us

e of

la

bora

tory

co

ntro

l or

gani

sms

for

both

st

anda

rdize

d di

ffusi

on

tech

niqu

es

and

stan

- da

rdize

d di

lutio

n te

chni

ques

. Th

e 30

μg

ce

ftiof

ur

sodi

um

disk

sh

ould

gi

ve

the

follo

wing

zo

ne

diam

eter

s an

d th

e ce

ftiof

ur

sodi

um

stan

dard

re

fere

nce

powd

er

(or

disk

) sh

ould

pr

ovid

e th

e fo

llowi

ng

MIC

va

lues

fo

r the

refe

renc

e st

rain

. The

cef

tiofu

r sod

ium

dis

ks o

r sta

ndar

d re

fere

nce

powd

er is

ap

prop

riate

for c

eftio

fur h

ydro

chlo

ride

(Tab

le 4

).

Tab

le 4

. Acc

epta

ble

qu

alit

y co

ntr

ol r

ang

es f

or

ceft

iofu

r

agai

nst

CL

SI r

eco

mm

end

ed A

mer

ican

Typ

e

Cu

ltu

re C

olle

ctio

n (

AT

CC

) re

fere

nce

str

ain

s

Org

anis

m (

AT

CC

No

.)Z

on

e d

iam

eter

* (m

m)

MIC

ran

ge

(μg

/mL

)

Esc

heric

hia

coli

(259

22)

26 to

31

0.25

to 1

.0

Sta

phyl

ococ

cus

aure

us (2

9213

)—

0.25

to 1

.0

Sta

phyl

ococ

cus

aure

us (2

5923

)27

to 3

1—

Pse

udom

onas

aer

ugin

osa

(278

53)

14 to

18

16.0

to 6

4.0

*All

test

ing

perfo

rmed

usi

ng a

30

μg d

isk.

EF

FE

CT

IVE

NE

SS

The

effe

ctiv

enes

s of

a

sing

le

intra

mam

mar

y (IM

M)

infu

sion

of

ce

ftiof

ur

hydr

ochl

orid

e fo

r th

e tre

atm

ent

of

subc

linic

al

mas

ti-tis

pr

esen

t at

th

e tim

e of

dr

y of

f wa

s de

mon

stra

ted

in

a ra

ndom

-ize

d bl

ock

desi

gn

stud

y. Ni

nete

en

vete

rinar

y in

vest

igat

ors

enro

lled

cows

in

21

herd

s an

d fro

m th

ese

21 h

erds

, 431

cow

s an

d 17

08 q

uarte

rs m

et e

nrol

lmen

t cr

iteria

in th

e st

udy

and

calv

ed w

ithin

a 4

5 to

60

day

perio

d fo

llowi

ng e

nrol

lmen

t. Th

e en

rollm

ent c

riter

ia w

ere

whol

e ud

der

som

atic

cel

l cou

nts

grea

ter

than

400

,000

ce

lls/m

L or

a l

inea

r so

mat

ic c

ell

coun

t sc

ore

grea

ter

than

or

equa

l to

5.

Milk

m

icro

biol

ogic

sa

mpl

es

were

ob

tain

ed

prio

r to

tre

atm

ent

and

at

Days

3

and

5 po

st-c

alvi

ng.

Ther

e we

re

5 tre

atm

ent

grou

ps

incl

u-

ding

a

nega

tive

cont

rol

grou

p.

Ther

e we

re

43

cows

in

th

e ne

gativ

e co

ntro

l gr

oup

and

51

cows

in

th

e 50

0 m

g ce

ftiof

ur

grou

p th

at

had

a po

sitiv

e pr

e-tre

atm

ent

milk

cu

lture

th

at

were

ev

alua

ted

for

treat

-m

ent

succ

ess.

Th

e pr

imar

y de

cisi

on

varia

ble

was

the

mic

robi

olog

ic

(ther

apeu

tic)

cure

in

wh

ich

bact

eria

is

olat

ed

pre-

treat

men

t we

re

abse

nt fr

om b

oth

post

-trea

tmen

t sam

ples

.

In

an

othe

r st

udy

in

elev

en

stud

y he

rds,

44

6 co

ws

with

a

so-

mat

ic

cell

coun

t (S

CC)

grea

ter

than

or

eq

ual

to

400,

000

cells

/mL

or

a lin

ear

scor

e gr

eate

r th

an

or

equa

l to

5

were

en

rolle

d.

Cows

wi

th

a dr

y pe

riod

of a

t lea

st 4

5 da

ys w

ere

bloc

ked

by la

ctat

ion

(1st

+ 2

nd o

r ≥3r

d). A

sin

gle

quar

ter m

ilk sa

mpl

e was

asep

tical

ly o

btai

ned

from

all f

our q

uarte

rs fo

r bac

teria

l cul

ture

pr

ior t

o tre

atm

ent a

nd o

n Da

ys 3

and

5 p

ost-c

alvi

ng. T

here

wer

e 4

treat

men

t gro

ups

incl

udin

g a

nega

tive

cont

rol.

Ther

e we

re 8

4 co

ws in

the

nega

tive

cont

rol a

nd 7

3 in

th

e 50

0 m

g ce

ftiof

ur g

roup

that

had

a p

ositi

ve p

re-tr

eatm

ent m

ilk c

ultu

re th

at w

ere

eval

uate

d fo

r tre

atm

ent s

ucce

ss. T

he p

rimar

y de

cisi

on v

aria

ble

was

the

mic

robi

olog

ic

(ther

apeu

tic) c

ure i

n wh

ich

bact

eria

isol

ated

pre

-trea

tmen

t wer

e abs

ent f

rom

bot

h po

st-

treat

men

t sam

ples

.

Ce

ftiof

ur

was

foun

d to

be

ef

fect

ive

agai

nst

Sta

phyl

ococ

cus

au-

reus

, S

trep

toco

ccus

dy

sgal

actia

e,

and

Str

epto

cocc

us

uber

is,

when

co

mpa

red

to

nega

tive

cont

rols

. Th

is

intra

mam

mar

y ce

ftiof

ur

form

ula-

tio

n wa

s we

ll to

lera

ted.

No

adve

rse

form

ulat

ion

rela

ted

even

ts w

ere

note

d du

ring

the

entir

e st

udy.

A la

rge

mul

ti-lo

catio

n fie

ld d

ose

confi

rmat

ion

stud

y an

d a

pilo

t stu

dy

dem

onst

rate

d th

at 5

00 m

g of

cef

tiofu

r inf

used

onc

e pe

r qua

rter a

t the

tim

e of

dry

off

was e

ffect

ive f

or th

e tre

atm

ent o

f sub

clin

ical

mas

titis

in d

airy

cattl

e at t

he ti

me o

f dry

off.

AN

IMA

L S

AF

ET

Y

An

udd

er ir

ritat

ion

stud

y wa

s co

nduc

ted

in 2

2 he

alth

y la

ctat

ing

dairy

cow

s to

as

sess

udd

er ir

ritat

ion

follo

wing

a s

ingl

e in

tram

amm

ary

infu

sion

of a

ste

rile

oil-b

ased

su

spen

sion

con

tain

ing

500

mg

of c

eftio

fur i

nto

all f

our q

uarte

rs fo

llowe

d by

milk

-out

12

hou

rs la

ter.T

hrou

ghou

t the

10

day

post

-trea

tmen

t obs

erva

tion

perio

d th

ere

was

a cl

inic

ally

in

sign

ifica

nt

rise

in

SCC

to

mea

n le

vels

<2

00,0

00

cells

/mL

from

th

e pr

e-in

fusi

on

leve

l of

<6

9,00

0 ce

lls/m

L.

No

clin

ical

si

gns

of

ud-

der

irrita

tion

(swe

lling

, pa

in,

or

redn

ess)

, ch

ange

s in

re

ctal

te

m-

pera

ture

, or c

hang

es in

milk

pro

duct

ion

were

not

ed in

this

stud

y. Cl

inic

al o

bser

vatio

ns

were

mad

e du

ring

a GL

P re

sidu

e de

plet

ion

stud

y of

36

cows

follo

wing

a s

ingl

e in

tra-

mam

mar

y in

fusi

on o

f a s

teril

e oi

l-bas

ed s

uspe

nsio

n co

ntai

ning

500

mg

of c

eftio

fur

into

all

four

qua

rters

at t

he e

nd o

f lac

tatio

n. N

o re

port

of u

dder

irrit

atio

n or

adv

erse

re

actio

n wa

s no

ted

in th

e da

ily v

isua

l obs

erva

tions

ove

r th

e 14

day

s im

med

iate

ly

follo

wing

trea

tmen

t. Co

llect

ivel

y, th

ese

stud

ies

dem

onst

rate

that

the

intra

mam

mar

y in

fusi

on o

f an

oil-b

ased

ste

rile

susp

ensi

on c

onta

inin

g 50

0 m

g of

cef

tiofu

r onc

e in

to

all f

our q

uarte

rs a

t the

end

of l

acta

tion

is c

linic

ally

saf

e an

d no

n-irr

itatin

g to

the

udde

r of

non

-lact

atin

g da

iry c

ows.

MIL

K A

ND

TIS

SU

E R

ES

IDU

E D

EP

LE

TIO

N

A

met

abol

ism

stu

dy in

cat

tle u

sing

rad

iola

bele

d ce

ftiof

ur p

rovi

ded

the

data

to

esta

blis

h to

lera

nces

for c

eftio

fur-r

elat

ed re

sidu

es (a

s de

sfur

oylc

eftio

fur)

in ti

ssue

and

m

ilk. T

hese

tole

ranc

es o

f cef

tiofu

r res

idue

s are

0.1

ppm

in m

ilk, 0

.4 p

pm in

kidn

ey, 2

.0

ppm

in li

ver a

nd 1

.0 p

pm in

mus

cle.

Pi

vota

l re

sidu

e de

clin

e st

udie

s we

re c

ondu

cted

to

asse

ss t

he d

eple

tion

of

cefti

ofur

-rel

ated

resi

dues

, mea

sure

d as

des

furo

ylce

ftiof

ur u

sing

the

offic

ial a

naly

tical

m

etho

d, in

tiss

ues

of tr

eate

d co

ws, i

n m

ilk fr

om tr

eate

d co

ws, a

nd in

tiss

ues

of c

alve

s bo

rn to

trea

ted

cows

. In

thes

e st

udie

s, n

onm

astit

ic c

ows

rece

ived

500

mg

of c

eftio

fur

per

quar

ter

into

all

four

qua

rters

onc

e at

dry

off.

The

milk

res

idue

dep

letio

n st

udy

dem

onst

rate

d th

at m

ilk p

rodu

ced

at ca

lvin

g m

ay b

e use

d fo

r hum

an co

nsum

ptio

n wi

th

no d

isca

rd p

erio

d wh

en th

e tre

atm

ent t

o ca

lvin

g in

terv

al is

30

days

or m

ore.

The

tiss

ue

depl

etio

n st

udy

mea

sure

d re

sidu

es in

the

tissu

es o

f tre

ated

cow

s an

d in

the

tissu

es o

f ne

onat

al c

alve

s bo

rn to

trea

ted

cows

. In

neon

atal

cal

ves

born

to tr

eate

d co

ws, t

issu

e re

sidu

es w

ere l

ess t

han

the c

odifi

ed to

lera

nces

for k

idne

y, liv

er an

d m

uscl

e. T

hese

dat

a su

ppor

t a z

ero

day

pre-

slau

ghte

r with

draw

al p

erio

d fo

r cal

ves

born

to tr

eate

d co

ws

when

the

treat

men

t to

calv

ing

inte

rval

is 3

0 da

ys o

r m

ore,

reg

ardl

ess

of c

olos

trum

co

nsum

ptio

n. T

he ti

ssue

resi

due

depl

etio

n da

ta s

uppo

rt a

16-d

ay p

re-s

laug

hter

with

-dr

awal

per

iod

follo

wing

intra

mam

mar

y in

fusi

on fo

r tre

ated

cow

s.

STO

RA

GE

CO

ND

ITIO

NS

Stor

e at

con

trolle

d ro

om te

mpe

ratu

re 2

0° to

25°

C (6

8° to

77°

F).

Prot

ect f

rom

lig

ht. S

tore

pla

stet

s in

car

ton

until

use

d.

HO

W S

UP

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f 12–

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ispo

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e Syr

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12

indi

vidu

ally

wr

appe

d 70

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sopr

opyl

alc

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pad

s an

d in

pai

ls c

onta

inin

g 12

unb

roke

n pa

ckag

es o

f 12-

10 m

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ASTE

T® D

ispo

sabl

e Sy

ringe

s wi

th 1

44 i

ndiv

idua

lly

wra

pped

70%

isop

ropy

l alc

ohol

pad

s.

NA

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www.

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and

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so

diu

m s

usp

ensi

on

Fo

r th

e Tr

eatm

ent o

f Su

bcl

inic

al M

astit

is in

Dry

Cow

s

Fo

r U

dder

Inst

illat

ion

in D

ry C

ows

On

ly

FO

R U

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IN A

NIM

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NLY

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OT

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UM

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Res

tric

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On

ly a

s D

irec

ted

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ia)

DE

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isp

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Nov

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um e

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novo

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......

......

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......

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400

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icill

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pro

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e ...

......

......

......

......

......

......

......

......

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200,

000

IUC

hlor

obut

anol

anh

ydro

us

(chl

oral

der

ivat

ive—

used

as

a pr

eser

vativ

e) ...

50

mg

in a

spe

cial

blan

d ve

hicl

e M

anuf

actu

red

by a

non

-ste

riliz

ing

proc

ess.

IND

ICA

TIO

NS

FO

R U

SE

ALB

AD

RY

PLU

S S

uspe

nsio

n is

ind

icat

ed f

or t

he t

reat

men

t, in

dry

co

ws

only

, of

sub

clin

ical

mas

titis

cau

sed

by s

usce

ptib

le s

trai

ns o

f S

taph

yloc

occu

s au

reus

and

Str

epto

cocc

us a

gala

ctia

e.

WA

RN

ING

S 1

. Do

not u

se le

ss th

an 3

0 da

ys p

rior

to c

alvi

ng.

2. M

ilk fr

om tr

eate

d co

ws

mus

t not

be

used

for

food

dur

ing

the

first

72

hou

rs a

fter

calv

ing.

3. T

reat

ed a

nim

als

mus

t no

t be

sla

ught

ered

for

foo

d fo

r 30

day

s fo

llow

ing

udde

r in

fusi

on.

PR

EC

AU

TIO

NS

Adm

inis

trat

ion

of th

is p

rodu

ct in

any

man

ner o

ther

than

sho

wn

unde

r D

OS

AG

E m

ay r

esul

t in

drug

res

idue

s.

DO

SA

GE

Infu

se o

ne t

ube

per

quar

ter

at s

tart

of

dry

perio

d (b

ut n

ot le

ss t

han

30 d

ays

prio

r to

cal

ving

).

Sh

ake

Wel

l Bef

ore

Usi

ng

DIR

EC

TIO

NS

FO

R U

SIN

G T

HE

FL

EX

I-TU

BE

® S

YS

TE

MT

he F

LEX

I-T

UB

E is

des

igne

d to

pro

vide

the

choi

ce o

f eith

er in

sert

ion

of th

e fu

ll ca

nnul

a, a

s ha

s tr

aditi

onal

ly b

een

prac

ticed

, or i

nser

tion

of

no m

ore

than

1 ⁄8 i

nch

of th

e ca

nnul

a, a

s re

com

men

ded

by th

e N

atio

nal

Mas

titis

Cou

ncil.

a. F

ull

Inse

rtio

n:

Rem

ove

the

blue

end

cap

by

pulli

ng s

trai

ght

up.

Gen

tly in

sert

the

ful

l can

nula

into

the

tea

t ca

nal;

care

fully

infu

se

the

prod

uct.

b. P

arti

al I

nse

rtio

n:

Rem

ove

both

the

blu

e en

d ca

p an

d th

e re

d ca

nnul

a by

pus

hing

sid

eway

s. G

ently

inse

rt th

e ex

pose

d bl

ue ti

p in

to th

e te

at c

anal

; car

eful

ly in

fuse

the

prod

uct.

AD

MIN

IST

RA

TIO

NA

t th

e tim

e of

dry

ing

off,

but

not

less

tha

n 30

day

s pr

ior

to c

alvi

ng,

milk

the

udde

r dr

y. W

ash

the

teat

s an

d ud

der

thor

ough

ly w

ith w

arm

w

ater

con

tain

ing

a su

itabl

e da

iry a

ntis

eptic

. Dry

the

teat

s an

d ud

der

tho

rou

gh

ly.

Infu

se e

ach

qu

art

er

usi

ng

th

e f

ollo

win

g p

roce

du

re.

Usi

ng th

e al

coho

l pad

s pr

ovid

ed, s

crub

eac

h te

at e

nd c

lean

usi

ng a

se

para

te p

ad fo

r ea

ch t

eat.

War

m A

LBA

DR

Y P

LUS

Sus

pens

ion

to

body

tem

pera

ture

and

sha

ke th

orou

ghly

. Cho

ose

the

desi

red

inse

rtio

n le

ngth

(ful

l or p

artia

l) an

d in

sert

tip

into

teat

can

al. I

nstil

l ent

ire c

onte

nts

into

the

quar

ter.

Mas

sage

the

udde

r af

ter

trea

tmen

t to

dist

ribut

e th

e A

LBA

DR

Y P

LUS

Sus

pens

ion

thro

ugho

ut th

e qu

arte

rs. U

sing

a s

uita

ble

teat

dip

, dip

all

teat

s fo

llow

ing

trea

tmen

t.

Dis

card

Em

pty

Con

tain

er; D

O N

OT

RE

-US

E

KE

EP

OU

T O

F R

EA

CH

OF

CH

ILD

RE

N

STO

RA

GE

CO

ND

ITIO

NS

Sto

re a

t con

trol

led

room

tem

pera

ture

20°

to 2

5°C

(68

° to

77°

F)

[see

U

SP

].

HO

W S

UP

PL

IED

ALB

AD

RY

PLU

S S

uspe

nsio

n is

ava

ilabl

e in

unb

roke

n pa

ckag

es o

f 12

-10

mL

PLA

ST

ET

Dis

posa

ble

Syr

inge

s w

ith 1

2 in

divi

dual

ly w

rapp

ed

70%

isop

ropy

l alc

ohol

pad

s an

d un

brok

en p

acka

ges

of 1

44-1

0 m

L P

LAS

TE

T D

ispo

sabl

e S

yrin

ges

with

144

indi

vidu

ally

wra

pped

70%

is

opro

pyl a

lcoh

ol p

ads.

For

a co

py o

f th

e M

ater

ial S

afet

y D

ata

She

et (

MS

DS

) or

to

repo

rt

adve

rse

reac

tions

cal

l Pfiz

er A

nim

al H

ealth

at 1

-800

-366

-528

8.

NA

DA

#55

-098

, Ap

pro

ved

by

FD

AM

ade

in th

e U

nite

d K

ingd

om fo

r

By

Nor

broo

k La

bora

torie

s Li

mite

d N

ewry

, BT

35 6

JP, N

orth

ern

Irel

and

Rev

ised

Dec

embe

r 19

99

812

404

007