300 PRO LA - Norbrook Laboratories

300 PRO LA
℞
®
(OXYTETRACYCLINE 300 mg/mL)
METAPHYLAXIS
BRD
PINKEYE
FOOTROT
SCOURS
THE LONG-ACTING ANTIBIOTIC
FOR BRD AND PINKEYE
300
300 PRO LA - Proven Benefits At The
PRO LA
®
Right Price. The Practical Treatment.
300 PRO LA (oxytetracycline) is a versatile, broadspectrum antibiotic available only through veterinarians.
Its high cure rate and longer duration make it ideal
for multiple treatment protocols including where BRD
metaphylaxis is indicated. 300 PRO LA® is approved for
use in beef cattle, non-lactating dairy cattle, calves,
pre-ruminating (veal) calves and swine.
(oxytetracycline 300 mg/mL)
®
300 PRO LA® Offers These Advantages:
• Long Lasting - Studies have shown when 300
PRO LA® is administered once intramuscularly or
subcutaneously to cattle at 13.6 mg per pound body
weight, blood concentrations of greater than 0.2 μg/mL
have been observed for at least 7 to 8 days
• Proven - 300 PRO LA® is a patented formulation
developed by Norbrook Laboratories. This unique
formulation has been proven by field use in the United
States, Canada and several countries around the globe
• Multi-Species Approval - 300 PRO LA® is approved for
use in beef cattle, non-lactating dairy cattle, calves,
including pre-ruminating (veal) calves and swine
• High Cure Rate - Data analysis from field studies
conclude this product to be effective in the control
of respiratory diseases of cattle at high risk of
development of BRD associated with Pasteurella spp.
• Safety - Oxytetracycline 300 PRO LA® has a proven
history of safe use
• Broad-Spectrum - The active ingredient,
oxytetracycline at 300 mg/mL, is effective against
a wide range of diseases caused by susceptible
gram-positive and gram-negative bacteria
www.norbrookinc.com
FOR VETERINARY USE ONLY
The Norbrook logos are registered trademarks of Norbrook Laboratories Limited
300 PRO LA® is a registered trademark of Norbrook Laboratories Limited
®
Cattle
Disease
BRD (Pneumonia,
Shipping fever complex)
Pinkeye
Scours
Footrot
Diphtheria
Leptospirosis
Wooden tongue
Acute metritis and
wound infections
Disease
Bacteria
Pasteurella spp.
Histophilus spp.
Moraxella bovis
Escherichia coli
Fusobacterium necrophorum
Fusobacterium necrophorum
Leptospira pomona
Actinobacillus lignieresii
Strains of staphylococcal
and streptococcal organisms
sensitive to oxytetracycline
Swine
Bacteria
Bacterial enteritis (scours, colibacillosis)
Escherichia coli
Bacterial Pneumonia
Leptospirosis
Infectious enteritis (baby pig scours,
colibacillosis) in suckling pigs
Pasteurella multocida
Leptospira pomona
Escherichia coli
• Economical- Excellent per-dose value
• Convenient Packaging - 100 mL, 250 mL and 500 mL
bottles.
Observe label directions and withdrawal times. Not for use in lactating dairy
animals. Adverse reactions, including injection site swelling, restlessness,
ataxia, trembling, respiratory abnormalities (labored breathing), collapse and
possibly death have been reported. See product labeling
for full product information.
PLASMA LEVELS
Mean Plasma Oxytetracycline Levels In Cattle
From 3 to 9 Days Post Administration of
300 PRO LA® at 9 mg/lb. and 13.6 mg/lb.
1.2
6
13.6 mg/lb.
9 mg/lb.
0.8
0.6
4
3
0.4
2
0.2
1
72
96
120
144
Hours
168
13.6 mg/lb.
9 mg/lb.
5
μg/mL
1.0
μg/mL
7
Mean Plasma Oxytetracycline Levels In Cattle
After Administration of 300 PRO LA®
at 9 mg/lb. and 13.6 mg/lb.
192
216
24
48
72
96
120
Hours
144
168
192
• Rapid absorption with effective levels in less than 1 hour
• Extra-long acting, up to 8 days based upon the MIC for the bacteria associated with BRD
•G
ood distribution into the lungs, liver, spleen and kidneys and into body fluids such as synovial and
cerebrospinal fluids
FLEXIBLE DOSAGE- CATTLE
Single IM/SQ Dose
13.6 mg/lb.
•M
etaphylactic use in cattle at high risk
of developing BRD associated with
Mannheimia (Pasteurella) haemolytica
Single IM/SQ Dose
9 mg/lb. - 13.6 mg/lb.
IM/SQ/IV Dose
3 mg/lb. - 5 mg/lb.
• Bacterial Pneumonia caused by
Pasteurella spp. (shipping fever)
• S cours (E. coli)
• Infectious bovine keratoconjunctivitis
(pinkeye) caused by Moraxella bovis
• L eptospirosis (L. Pomona)
•D
iphtheria (F. necrophorum)
• Wooden Tongue (A. lignieresii)
•A
cute metritis and wound infections
(strains of staphylococcal and streptococcal
organisms sensitive to oxytetracycline)
FLEXIBLE DOSAGE- SWINE
Single IM Dose
3 mg/lb. - 5 mg/lb.
Single IM Dose
9 mg/lb.
•B
acterial Pneumonia caused by
Pasteurella multocida
METAPHYLAXIS
BRD
• Bacterial Enteritis (scours, colibacillosis)
caused by Escherichia coli
• Leptospirosis caused by Leptospira
pomona
PINKEYE
FOOTROT
Single Dose (Sows Only)
3 mg/lb.
• Infectious Enteritis (baby pig scours,
colibacillosis) in suckling pigs caused
by Escherichia coli
SCOURS
216
CATTLE DOSAGE GUIDE
The chart below illustrates the conversion of mg/lb. to mL’s in cattle. See product label for dosage, administration
and associated indications. For administration in swine, see product label.
Cattle Weight (lb.)
Number of mL’s
9 mg/lb.
13.6 mg/lb.
100
3.0
4.5
200
6.0
9.0
300
9.0
13.6
400
12.0
18.1
500
15.0
22.6
600
18.0
27.2
700
21.0
31.7
800
24.0
36.3
900
27.0
40.8
1000
30.0
45.3
1100
33.0
49.8
1200
36.0
54.4
PRODUCT INFORMATION
• Store at room temperature (59° - 86° F)
• Withdrawal period: Discontinue treatment 28 days
pre-slaughter when administered by IM, SQ or IV
PRO LA
ABOUT NORBROOK
Founded in 1968, Norbrook Laboratories Ltd has grown to become one of the
world’s leading veterinary and human pharmaceutical companies. Norbrook
develops, manufactures and markets products to over 120 countries worldwide.
300 PRO LA® IS AVAILABLE ONLY THROUGH VETERINARIANS
300
®
(oxytetracycline 300 mg/mL)
℞
NADA 141-143, APPROVED
NADA 141-143,
BY FDA
APPROVED BY FDA
enteritis (scours, colibacillosis)
enteritis (scours,
caused
colibacillosis)
by Escherichia
caused by Escherichia
coli; pneumonia caused
coli; pneumonia
by Pasteurella
caused
multocida;
by Pasteurella
and multocida; and
leptospirosis caused
leptospirosis
by Leptospira
caused
pomona.
by Leptospira pomona.
In sows 300 PRO LA
In sows
is indicated
300 PRO
asLA
an isaid
indicated
in control
asofan aid in control of
infectious enteritisinfectious
(baby pigenteritis
scours, (baby
colibacillosis)
pig scours,
in colibacillosis) in
suckling pigs caused
suckling
by Escherichia
pigs caused
coli.
by Escherichia coli.
300300
PROPRO
LA LA
(Oxytetracycline)
(Oxytetracycline)
Injection
Injection
PHARMACOLOGY:PHARMACOLOGY:
Oxytetracycline isOxytetracycline
derived from theismetabolic
derived from
activity
the metabolic
of
activity of
ANTIBIOTIC ANTIBIOTIC
the actinomycete,the
Streptomyces
actinomycete,
rimosus.
Streptomyces
Oxytetracycline
rimosus. Oxytetracycline
is an antimicrobialisagent
an antimicrobial
that is effective
agentinthat
the is
treatment
effective in the treatment
Each mL containsEach
300 mg
mLofcontains
oxytetracycline
300 mg ofbase
oxytetracycline
as
base
of a wide
as range ofofdiseases
a wide range
caused
of by
diseases
susceptible
caused by susceptible
amphoteric oxytetracycline.
amphoteric oxytetracycline.
gram-positive andgram-positive
gram-negative
and
bacteria.
gram-negative bacteria.
For Use in Beef Cattle,
For Use
Non-lactating
in Beef Cattle,
Dairy
Non-lactating
Cattle, Calves,
Dairy Cattle,
The antibiotic
Calves, activity
The antibiotic
of oxytetracycline
activity ofisoxytetracycline
not appreciablyis not appreciably
Including Pre-ruminating
Including(Veal)
Pre-ruminating
Calves and(Veal)
Swine.Calves and Swine.
diminished in the presence
diminishedofinbody
the presence
fluids, serum
of body
or fluids, serum or
exudates.
exudates.
READ ENTIRE BROCHURE
READ ENTIRE
CAREFULLY
BROCHURE
BEFORE
CAREFULLY
USING BEFORE USING
THIS PRODUCT. THIS PRODUCT.
Studies have shown
Studies
that the
have
half-life
shownofthat
oxytetracycline
the half-life ofinoxytetracycline in
blood following intramuscular
blood following
treatment
intramuscular
with 300treatment
PRO LA with 300 PRO LA
Caution: Federal law
Caution:
restricts
Federal
this drug
law restricts
to use bythis
or on
drug
theto use at
by5ormg
onper
thepoundatof5bodyweight
mg per pound
is approximately
of bodyweight23
is hours
approximately 23 hours
order of a licensedorder
veterinarian.
of a licensed veterinarian.
in cattle and 18 hours
in cattle
in swine.
and 18 hours in swine.
INTRODUCTION: INTRODUCTION:
Studies have shown
Studies
whenhave
300 PRO
shown
LA when
is
300 PRO LA is
300 PRO LA (Oxytetracycline)
300 PRO LA (Oxytetracycline)
Injection is a sterile,
Injection
ready is
to a sterile,
administered
ready to onceadministered
intramuscularly
oncetointramuscularly
cattle or swine to
at cattle or swine at
use solution of theuse
broad-spectrum
solution of theantibiotic
broad-spectrum antibiotic 9 mg per pound of9bodyweight,
mg per pound
blood
of bodyweight,
oxytetracycline
blood oxytetracycline
oxytetracycline dihydrate.
oxytetracycline
Oytetracycline
dihydrate.
is an
Oytetracycline is anconcentration of greater
concentration
than 0.2ofmcg/mL
greaterhave
than been
0.2 mcg/mL have been
antimicrobial agent
antimicrobial
that is effective
agentinthat
treatment
is effective
of a wide
in treatment
observed
of a wide
for 3 to 4observed
days. for 3 to 4 days.
range of diseasesrange
caused
of by
diseases
susceptible
caused
gram-positive
by susceptible gram-positive
and gram-negative
and
bacteria.
gram-negative bacteria.
Studies have shown
Studies
whenhave
300 PRO
shown
LA when
is
300 PRO LA is
administered onceadministered
intramuscularly
onceorintramuscularly
subcutaneouslyortosubcutaneously to
300 PRO LA should300
bePRO
stored
LA at
should
roombe
temperature
stored at room
59°-86°F
temperature
cattle59°-86°F
at 13.6 mg per
cattle
pound
at 13.6
of bodyweight,
mg per pound
blood
of bodyweight, blood
(15°-30°C). The antibiotic
(15°-30°C).
activity
The antibiotic
of oxytetracyline
activity is
ofnot
oxytetracyline
oxytetracycline
is not
concentration
oxytetracycline
of greater
concentration
than 0.2ofmcg/mL
greater than 0.2 mcg/mL
appreciably diminished
appreciably
in the presence
diminishedofinbody
the presence
fluids, of body
have
fluids,
been observed
have
forbeen
at least
observed
7 to 8 days.
for at least 7 to 8 days.
serum or exudates.
serum or exudates.
DOSAGE AND ADMINISTRATION:
DOSAGE AND ADMINISTRATION:
INGREDIENTS: INGREDIENTS:
Beef cattle, non-lactating
Beef cattle,
dairy
non-lactating
cattle, calves,
dairy
including
cattle, calves, including
300 PRO LA (Oxytetracycline)
300 PRO LA (Oxytetracycline)
Injection is a sterile,
Injection is a sterile,
pre-ruminating (veal)
pre-ruminating
calves:
(veal) calves:
pre-constituted solution
pre-constituted
of the broad-spectrum
solution of theantibiotic
broad-spectrumA antibiotic
single intramuscular
A single
or subcutaneous
intramuscular dosage
or subcutaneous
of 13.6 mgdosage of 13.6 mg
oxytetracycline dihydrate.
oxytetracycline
Each mL
dihydrate.
containsEach
300 mg
mL contains 300
of oxytetracycline
mg
ofper
oxytetracycline
pound of bodyweight,
per pound
300ofPRO
bodyweight,
LA is
300 PRO LA is
oxytetracycline asoxytetracycline
base, 40% (v/v)as
glycerol
base, 40%
formal,
(v/v)10%
glycerol formal,
recommended
10%
forrecommended
the control of respiratory
for the control
disease
of respiratory
in
disease in
(v/v) polyethylene(v/v)
glycol
polyethylene
200, 2.7% (w/v)
glycol
magnesium
200, 2.7% (w/v)
oxide,magnesium
cattle at
oxide,
high risk cattle
of developing
at high risk
BRDofassociated
developingwith
BRD associated with
0.4% (w/v) sodium0.4%
formaldehyde
(w/v) sodium
sulphoxylate
formaldehyde
(as asulphoxylate Mannheimia
(as a
(Pasteurella)
Mannheimia
haemolytica.
(Pasteurella) haemolytica.
preservative) and preservative)
monoethanolamine
and monoethanolamine
(as required to (as required to
At a single intramuscular
At a single
or subcutaneous
intramuscular dose
or subcutaneous
range of
dose range of
adjust pH).
adjust pH).
9 to 13.6 mg of oxytetracycline
9 to 13.6 mg ofper
oxytetracycline
pound of bodyweight,
per pound of bodyweight,
300 PRO LA is recommended
300 PRO LA in
is the
recommended
treatment ofinthe
the treatment of the
INDICATIONS: INDICATIONS:
conditions:
following conditions:
300 PRO LA is intended
300 PRO
for LA
useisinintended
treatment
forfor
usethe
in treatment forfollowing
the
following diseasesfollowing
when due
diseases
to
when due to
(1) Bacterial pneumonia
(1) Bacterial
caused
pneumonia
by Pasteurella
caused
sppby Pasteurella spp
oxytetracycline-susceptible
oxytetracycline-susceptible
organisms:
organisms:
(shipping
fever)
in
(shipping
calves
and
fever)
yearlings
in
calves
where
and yearlings where
retreatment is impractical
retreatment
dueistoimpractical
husbandry due
conditions,
to husbandry conditions,
Beef cattle, non-lactating
Beef cattle,
dairy
non-lactating
cattle, calves,
dairy
including
cattle, calves, including
such as cattle on such
range,asorcattle
where
ontheir
range,
repeated
or where their repeated
pre-ruminating (veal)
pre-ruminating
calves:
(veal) calves:
restraint is inadvisable.
restraint is inadvisable.
300 PRO LA is indicated
300 PRO
in LA
theistreatment
indicatedofinpneumonia
the treatment
andof pneumonia and
(2) Infectious
(2) Infectious
kertaconjunctivitis
bovine kertaconjunctivitis
(pink eye) caused(pink eye) caused
shipping fever complex
shipping
associated
fever complex
with Pasteurella
associatedspp.,
with Pasteurella
spp., bovine
by Moraxella bovis.
by Moraxella bovis.
and Histophilus spp.
and300
Histophilus
PRO LA is
spp.
indicated
300 PRO
forLA
theis indicated for the
treatment of infectious
treatment
bovine
of infectious
keratoconjunctivitis
bovine keratoconjunctivitis
(pink
(pinkindications
For other
For 300
other
PRO
indications
LA is to be
300administered
PRO LA is to be administered
eye) caused by Moraxella
eye) caused
bovis,
byfoot-rot
Moraxella
andbovis,
diphtheria
foot-rot and diphtheria
intramuscularly,
subcutaneously
intramuscularly,orsubcutaneously
intravenously atoraintravenously
level
at a level
caused by Fusobacterium
caused by
necrophorum;
Fusobacterium
bacterial
necrophorum;
enteritisbacterial
enteritis
of
3
to
5
mg
of
oxytetracycline
of
3
to
5
mg
of
per
oxytetracycline
pound
of
bodyweight
per
pound
of
bodyweight
(scours) caused by
(scours)
Escherichia
caused
coli;
bywooden
Escherichia
tongue
coli; wooden tongue
per day. In treatment
per day.
of foot-rot
In treatment
and advanced
of foot-rot
cases
andof
advanced cases of
caused by Actinobacillus
caused by
lignieresi;
Actinobacillus
leptospirosis
lignieresi;
caused
leptospirosis caused
other
indicated
diseases,
other
indicated
a
dosage
diseases,
level
of
5
a
mg
dosage
per
pound
level
of
5
mg
per pound
by Leptospira pomona;
by Leptospira
and wound
pomona;
infections
and wound
and acute
infections and
acute
of bodyweight
perofday
bodyweight
is recommended.
per day isTreatment
recommended.
should Treatment should
metritis caused bymetritis
strainscaused
of staphylococcal
by strains ofand
staphylococcal and
be
continued
hours
following
24
to
48
remission
hours
following
of
disease
remission
of disease
streptococcal organisms
streptococcal
sensitive
organisms
to oxytetracycline.
sensitive toAlso,
oxytetracycline.
Also, 24 tobe48continued
signs,
signs,
to
exceed
however,
a
total
not
of
to
four
exceed
(4)
a
total of four (4)
it is indicated for the
it iscontrol
indicated
of respiratory
for the control
disease
of respiratory
in
disease
inhowever, not
consecutive days.consecutive
If improvement
days.
is Ifnot
improvement
noted withinis24
not
tonoted within 24 to
cattle at high risk cattle
of developing
at high risk
BRDofassociated
developingwith
BRD associated
48 with
hours of the beginning
48 hoursofoftreatment,
the beginning
diagnosis
of treatment,
and diagnosis and
Mannheimia (Pasteurella)
Mannheimia
haemolytica.
(Pasteurella) haemolytica.
therapy should betherapy
re-evaluated.
should be re-evaluated.
Swine:
Swine:
Do not administerDo
intramuscularly
not administerinintramuscularly
the neck of small
in the neck of small
300 PRO LA is indicated
300 PRO
in LA
theistreatment
indicatedofinbacterial
the treatment of bacterial
calves due to lackcalves
of sufficient
due tomuscle
lack of sufficient
mass.
muscle mass.
Use extreme careUse
when
extreme
administering
care when
thisadministering
product by this product
symptoms
by may suggest
symptoms
an overgrowth
may suggest
of an
non-susceptible
overgrowth of non-susceptible
intravenous injection.
intravenous
Perivascular
injection.
injection
Perivascular
or leakage
injection or
organisms.
leakage If superinfections
organisms. Ifoccur,
superinfections
the use of this
occur, the use of this
from an intravenous
from
injection
an intravenous
may cause
injection
severemay
swelling
cause severe
product
swelling
should beproduct
discontinued
shouldand
be discontinued
appropriate specific
and appropriate specific
at the injection site.
at the injection site.
therapy should betherapy
instituted.
should be instituted.
Swine:
Swine:
Since bacteriostatic
Since
drugs
bacteriostatic
may interfere
drugs
withmay
the interfere with the
A single dosage ofA9single
mg ofdosage
oxytetracycline
of 9 mg ofper
oxytetracycline
pound of
perbactericidal
pound of actionbactericidal
of penicillin,
action
it is advisable
of penicillin,
to avoid
it is advisable to avoid
bodyweight administered
bodyweight
intramuscularly
administeredisintramuscularly
recommended is recommended
giving 300 PRO LAgiving
in conjunction
300 PRO LA
with
in penicillin.
conjunction with penicillin.
in the treatment ofinbacterial
the treatment
pneumonia
of bacterial
caused
pneumonia
by
caused by
Pasteurella multocida
Pasteurella
in swine,
multocida
where retreatment
in swine, where
is retreatment
STORAGE:
is
STORAGE:
impractical due toimpractical
husbandry due
conditions
to husbandry
or where
conditions or where
Store at room temperature,
Store at room
59-86°F
temperature,
(15-30°C).59-86°F
Keep from
(15-30°C). Keep from
repeated restraintrepeated
is inadvisable.
restraint is inadvisable.
freezing.
freezing.
300 PRO LA can also
300be
PRO
administered
LA can alsoby
beintramuscular
administered by intramuscular
WARNINGS:
WARNINGS:
injection at a levelinjection
of 3 to 5 at
mga of
level
oxytetracycline
of 3 to 5 mg ofper
oxytetracycline per
pound of bodyweight
pound
perofday.
bodyweight
Treatment
pershould
day. Treatment
be
should be WARNINGS: Discontinue
WARNINGS:
treatment
Discontinue
at leasttreatment
28
at least 28
continued 24 to 48continued
hours following
24 to 48remission
hours following
of disease
remission of disease
days prior to slaughter
days prior
of cattle
to slaughter
and swine.
of cattle
Not and swine. Not
signs; however, not
signs;
to exceed
however,
a total
not of
to four
exceed
(4) a total of four (4)
for use in lactatingfordairy
use animals.
in lactating
Rapid
dairy animals. Rapid
consecutive days.consecutive
If improvement
days.is Ifnot
improvement
noted withinis24
not
tonoted within
intravenous
24 to
administration
intravenous
may
administration
result in animal
may result in animal
48 hours of the beginning
48 hoursofoftreatment,
the beginning
diagnosis
of treatment,
and diagnosis and
collapse. Oxytetracycline
collapse.should
Oxytetracycline
be
should be
therapy should betherapy
re-evaluated.
should be re-evaluated.
administered intravenously
administered
slowly
intravenously
over a period
slowly over a period
of at least 5 minutes.
of at least 5 minutes.
For sows, administer
For once
sows,intramuscularly
administer once3 intramuscularly
mg of
3 mg of
oxytetracycline per
oxytetracycline
pound of bodyweight
per pound
approximately
of bodyweight approximately
The Material Safety
TheData
Material
SheetSafety
(MSDS)
Data
contains
Sheet more
(MSDS) contains more
eight (8) hours before
eightfarrowing
(8) hours or
before
immediately
farrowing
after
or immediatelydetailed
after occupational
detailed
safety
occupational
information.safety
To report
information. To report
completion of farrowing
completion
as anofaid
farrowing
in the control
as an of
aid in the control
adverse
of
effects, obtain
adverse
an effects,
MSDS or
obtain
for assistance,
an MSDS or for assistance,
infectious enteritisinfectious
in baby pigs.
enteritis in baby pigs.
contact Norbrookcontact
at 1-913-599-5777.
Norbrook at 1-913-599-5777.
tissue at slaughter.
tissue at slaughter.
9 mg
dosage
3 or
5 mg/lb volume of3 or 5 mg/lb volume of
of undiluted
diluted 300 PRO LA diluted 300 PRO LA
For swine weighing
For25swine
lbs ofweighing
bodyweight
25 lbs
andofunder,
bodyweight and under,
CAUTION:
CAUTION:
300 PRO LA should300
bePRO
administered
LA shouldundiluted
be administered
for treatment
undiluted for
Intramuscular
treatment or subcutaneous
Intramuscular injection
or subcutaneous
may result
injection
in
may result in
at 9 mg/lb but should
at 9be
mg/lb
administered
but shoulddiluted
be administered
for treatment
diluted for
local
treatment
tissue reactions
localwhich
tissuepersists
reactions
beyond
whichthe
persists
slaughter
beyond the slaughter
at 3 or 5 mg/lb. at 3 or 5 mg/lb.
withdrawal period.withdrawal
This may result
period.
in This
trim may
loss result
of edible
in trim loss of edible
9 mg dosage
of undiluted
0.30 mL10 lb
0.15 mL5 lb
Bodyweight
5 lb
1.0 mL 50 mg/mL
0.6 mL
0.30 mL50 mg/mL 0.6 mL
1.0 mL
37.5 mg/mL 0.4 mL
0.7 mL37.5 mg/mL
0.7 mL swelling
0.4 mL
0.15 mL
may cause
may
at cause
the injection
swelling
site.
at the injection site.
Intramuscular injection
Intramuscular
in the rump
injection
area may
in the
cause
rumpmild
area may cause mild
300 PRO LA
300 PRO LA
temporary
temporary
associated
lameness
with swelling
associated
at the
with swelling at the
5 mg/lb Dilution*
5 mg/lblameness
Bodyweight 3 mg/lb
9 mg/lb
9 mg/lbDilution* 3 mg/lb
injection site. Subcutaneous
injection site.
injection
Subcutaneous
in the neck
injection
area in the neck area
10 lb
053670I01
053670I01
ADVERSE
ADVERSE REACTIONS:
1.7 mL 75 mg/mL
1.7 mLREACTIONS:
1.0 mL
25 lb
0.75 mL25 lb
0.75 mL75 mg/mL 1.0 mL
Reports of adverse
Reports
reactions
of adverse
associated
reactions
with associated with
* To prepare dilutions,
* To prepare
add onedilutions,
part of 300
add
PRO
oneLApart
to three
of 300 PROoxytetracycline
LA to three administration
oxytetracycline
include
administration
injection site
include injection site
(3), five (5) or seven
(3),(7)
five
parts
(5) or
of seven
the sterile
(7) parts
water,
of the
or 5%
sterile water,
swelling,
or 5% restlessness,
swelling,
ataxia,
restlessness,
trembling, ataxia,
swelling
trembling,
of
swelling of
dextrose solutiondextrose
as indicated;
solution
the diluted
as indicated;
product
theshould
diluted product
eyelids,
should
ears, muzzle,
eyelids,
anusears,
and muzzle,
vulva (oranus
scrotum
and vulva
and (or scrotum and
be used immediately.
be used immediately.
sheath in males), respiratory
sheath in males),
abnormalities
respiratory
(labored
abnormalities (labored
breathing), frothing
breathing),
at the mouth,
frothing
collapse
at theand
mouth,
possibly
collapse and possibly
PRECAUTIONS: PRECAUTIONS:
death. Some of these
death.
reactions
Some ofmay
these
be reactions
attributed may
either
betoattributed either to
Exceeding the highest
Exceeding
recommended
the highest
level
recommended
of drug per level of drug
anaphylaxis
per
(an allergic
anaphylaxis
reaction)
(an allergic
or to cardiovascular
reaction) or to cardiovascular
pound of bodyweight
pound
perofday,
bodyweight
administering
per day,
more
administering
than the more
collapse
than of
theunknown
collapse
cause.
of unknown cause.
recommended number
recommended
of treatments,
number
and/or
of treatments,
exceeding and/or exceeding
10 mL intramuscularly
10 mLorintramuscularly
subcutaneouslyorper
subcutaneously
injection site per injection
PRESENTATION:
site
PRESENTATION:
in adult beef cattleinand
adult
non-lactating
beef cattle and
dairy
non-lactating
cattle and 5 dairy
mL cattle
300 and
PRO5LA
mLis available
300 PRO
in 100
LA ismL,
available
250 mL in
and
100
500
mL,
mL250
vials.
mL and 500 mL vials.
intramuscularly per
intramuscularly
injection site in
per
adult
injection
swine,site
may
in result
adult swine, may result
in antibiotic residues
in antibiotic
beyond the
residues
withdrawal
beyond
time.
the withdrawal time.
Livestock Drug - Not
Livestock
for Human
DrugUse.
- Not for Human Use.
Restricted Drug(s)Restricted
California.Drug(s)
Use Only
California.
as Directed.
Use Only as Directed.
Consult with your Consult
veterinarian
with your
prior veterinarian
to administering
priorthis
to administering this
product in order toproduct
determine
in order
the proper
to determine
treatment
the proper treatment
DISTRIBUTED BY:DISTRIBUTED BY:
required in the event
required
of an in
adverse
the event
reaction.
of an adverse
At the first
reaction. At
Norbrook,
the first Inc. Norbrook, Inc.
sign of any adverse
sign
reaction,
of any adverse
discontinue
reaction,
use ofdiscontinue
the
use Lenexa,
of the KS 66219 Lenexa, KS 66219
product and seek product
the advice
andofseek
yourthe
veterinarian.
advice of your
Some
veterinarian.
of
Some of
the reactions maythe
be reactions
attributable
may
either
be attributable
to anaphylaxis
either
(anto anaphylaxis
MADE IN(an
THE UK MADE IN THE UK
allergic reaction) allergic
or to cardiovascular
reaction) or to
collapse
cardiovascular
of
collapse of
unknown cause. unknown cause.
U.S. Patent No. 6,110,905
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
U.S. Patent No. 6,310,053
Shortly after injection
Shortly
treated
afteranimals
injectionmay
treated
haveanimals
transient
may have transient
hemoglobinuria resulting
hemoglobinuria
in darkened
resulting
urine.in darkened urine.
As with all antibiotic
As with
preparations,
all antibiotic
use preparations,
of this drug may
use of this drug may
result in overgrowth
result
of non-susceptible
in overgrowth oforganisms,
non-susceptible organisms,
including fungi. The
including
absence
fungi.
of a The
favourable
absence
response
of a favourable response
following treatment,
following
or the development
treatment, or of
thenew
development
signs or of new signs or
0816-143-I01A