Convenia (cefovecin sodium) in your practice
®
• Label dose for dogs and cats = 3.6 mg/lb
(8 mg/kg or 0.045 mL/lb) subcutaneously
• Reconstituted concentration = 80 mg/mL
• Reconstitute with 10 mL of sterile water for injection, USP
• Use within 56 days after reconstitution
• Always refrigerate in original carton to protect from light
• Minimum pet age for use is 4 months
As with other cephalosporins, CONVENIA will naturally turn
amber over time after reconstitution. The color change has
no impact on safety o r efficacy, provided CONVENIA is kept
under proper storage conditions.
0 Days
28 Days
42 Days
56 Days
Examples of color change after the vial has been broached and reconstituted.
CONVENIA Dosing Chart at 3.6 mg/lb
(8mg/kg or 0.045 mL/lb)
Weight of Animal
Volume of CONVENIA
5 lb
0.23 mL
10 lb
0.45 mL
15 lb
0.67 mL
20 lb
0.90 mL
40 lb
1.80 mL
60 lb
2.70 mL
80 lb
3.60 mL
100 lb
4.50 mL
Important Safety Information:
CONVENIA is not for use in dogs or cats with a history of allergic reactions to penicillins or
cephalosporins. Similar to other cephalosporins, side effects for both dogs and cats include
vomiting, diarrhea, decreased appetite/anorexia and lethargy. The safety of CONVENIA has
not been determined in lactating or breeding animals. For more safety information, refer to
the Full Prescribing Information.
All trademarks are the property of Zoetis Inc. or its subsidiaries, affiliates and licensees. ©2013 Zoetis Inc. All rights reserved. February 2013. AIF0113010
Hyper/Acting Strange
1
1
cefovecin or to β-lactam (penicillins and cephalosporins) group antimicrobials. Anaphylaxis
followingUrination
administration of 8 mg/kg body weight
has been reported with the use of this product in foreign market experience. If an allergic concentrations
Inappropriate
1 to dogs. Based upon these
0
predicted concentrations,
canine population
will have active
concentrations
Cats reaction or anaphylaxis occurs, CONVENIA should not be administered again and appropriate
MICROBIOLOGY:
CONVENIA 95%
is of
a the
cephalosporin
antibiotic.
Like (free)
otherdrugβ-lactam
>
the
MIC
of
S.
canis
(0.06
μg/mL)
for
approximately
14
days
and
free
concentrations
A total therapy
of 291 cats,
ranging
in age from
2.4 months
(1 require
cat) to 21
years, were
in the
antimicrobials,*Some
CONVENIA
exerts
inhibitory more
effectthan
by one
interfering
bacterial
Type of Disea
Infec
should
be instituted.
Anaphylaxis
may
treatment
with included
epinephrine
and other
cats may
haveitsexperienced
adversewith
reaction
or more than one
90
> the
MIC
forThis
S. of
intermedius
(0.25
μg/mL)
for
approximately
following
field study
safety analysis.
Adverse
reactions
reported
in cats treated
CONVENIA
and cell wall
synthesis.
interference
is primarily
due
to its
binding
to thea single
emergency
measures,
including
oxygen,
intravenous
fluids, with
intravenous
antihistamine,
occurrence
the same adverse
reaction
during
the covalent
study.7 days
90
8 mg/kg subcutaneous
injection(ie,
of cefovecin.
(See MICROBIOLOGY).
the active
control are summarized
Table 3.
penicillin-binding
proteins (PBPs)
transpeptidase
and carboxypeptidase), which
corticosteroids,
and airwayin management,
as clinically indicated. Adverse reactions may
Four
CONVENIA
cases
had
mildly
elevated
post-study
ALT
(1
case
was
elevated
pre-study).
are
essential
for
synthesis
of
the
bacterial
cell
wall.
For
E.
coli,
the
in
vitro
activity
of
prolonged
due toReactions
the prolonged
systemic
drugthe
clearance
(65 days).
Figure 2:No
Population
Predicted Free
Concentration
of Cefovecin
in Plasma Following a Single
Table 3:require
Number
of Cats*treatment
with Adverse
Reported
During
Field Study
with
Skin (wound
clinical abnormalities
were
noted with
these
findings.
CONVENIA
is comparable
to other
cephalosporins,
butin
due
the line
high-affinity
proteinInjection
of 8 mg/kg
Body Weight
Dogsto(solid
is population
prediction,
CONVENIA.
WARNINGS: Not for use in humans. Keep this and all drugs out of reach of children. Consult
a Subcutaneous
Twenty-four
casesof had
normal
pre-study
BUN
values
post-study
thconcentration
binding,
the lines
in
vivo
cefovecin
does notprediction).
reach
the and
MIC90elevated
for
Antimicrobial for Subcutaneous Injection in Dogs and Cats Only
dotted
are free
the 5CONVENIA
and 95th percentiles
for
the population
CONVENIA w
physician in case of accidental human exposure. For subcutaneous use in dogs and cats only.
BUN
values
(37
–
39
mg/dL
post-study).
There
were
6
CONVENIA
cases
with
normal
preand
E.
coli
(1.0
μg/mL).
CONVENIA
is
not
active
against
Pseudomonas
spp.
or
enterococci.
Skinpr
heartworm
CONVENIA
Antimicrobial
drugs, including penicillins and
cephalosporins, can Active
cause Control
allergic reactions in
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Adverse
Reaction
an vaccines
Infect
Each
mL of CONVENIA
reconstituted
lyophile
containsreactions,
cefovecin
sodium
equivalent
to 80 mg mildly to moderately elevated post-study creatinine values. Two of these cases also hadand
Dogs
(n=147)
(n=144)
sensitized
individuals.
To minimize
the possibility
of allergic
those
handling
such
DESCRIPTION: Cefovecin sodium is a semi-synthetic broad-spectrum antibacterial agent from the
elevatedconcentration
post-study BUN.
Novalues
clinical
werelabel-claim
noted withpathogens
these findings.
cefovecin,
methylparaben
1.8are
mg advised
(preservative),
propylparaben
0.2ofmg
sodium inhibitory
The minimum
(MIC)
forabnormalities
cefovecin against
antimicrobials,
including
cefovecin,
to avoid
direct contact
the(preservative),
product with
ANIMAL
SAF
cephalosporin class of chemotherapeutic agents. Cefovecin is the non-proprietary designation for
Vomiting
10
14
citrate
dihydrate
5.8 mg and citric acid monohydrate 0.1 mg, sodium hydroxide or hydrochloric
One
CONVENIA-treated
catinina a2001-2003
separate
field
study experienced
diarrhea
post-treatment
isolated
from
skin
infections
in
dogs
enrolled
field
effectiveness
study
are
presented
the
skin
and
mucous
membranes.
Dogs
(6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[(2S)-tetrahydro-2acid as required to adjust pH.
Diarrhea
7
26
lasting
42 days.
The diarrhea
resolved.
in Table 5. All MICs
were
determined
in accordance
with the Clinical and Laboratory Standards
CONVENIA ad
PRECAUTIONS: Prescribing antibacterial drugs in the absence of a proven or strongly
furanyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, monosodium salt.
Institute (CLSI) standards.
INDICATIONS:
Anorexia/Decreased
Appetite
6
FOREIGN MARKET EXPERIENCE: The following adverse events were reported voluntarily
and 60 mg/kg (
suspected
bacterial
infection is unlikely to provide
benefit to treated6 animals and may
Figure 1: Chemical structure of cefovecin sodium.
post-approval
use
of the product
in dogs
and cats
in foreign
markets: death, tremors/
a total ofCats
5 dos
Table 5: Activityduring
of CONVENIA
against
Pathogens
Isolated
from Dogs
Treated
with CONVENIA
increaseDogs
the risk of the development of drug-resistant
animal pathogens.6
Lethargy
6
anaphylaxis,
vomitingThe
andM
t
in
Field Studiesataxia,
in theseizures,
US During
2001-2003. acute pulmonary edema, facial edema, injection site reactions
CONVENIA
is
indicated
for
the
treatment
of
skin
infections
(secondary
superficial
pyoderma,
The
safe
use
of
CONVENIA
in
dogs
or
cats
less
than
4
months
of
age
(see
Animal
Safety)
and
Hyper/Acting Strange
1
1
(alopecia, scabs, necrosis, and erythema), hemolytic anemia, salivation, pruritus, lethargy,
site
irritation
a
abscesses,
and
wounds)
in
dogs
caused
by
susceptible
strains
of
Staphylococcus
intermedius
(woun
in breeding
or lactating animals has not been determined.
Safety has not
Inappropriate
Urination
0 been established
vomiting, diarrhea,
and inappetance.
with repeat
inje
Streptococcus canis
(Group G).effects1on injection sites have not
prese
Number Sample
MIC
Microbiological
for IM orand
IV administration.
The long-term
been determined.
MICor50 toMIC
Collection
lasting > 30 da
90 Range
For a copy ofTreatment
the Material Safety
Data
Sheet
(MSDS)
report
a suspected adverse
of
Disease Pathogen
is slowly
eliminatedmore
from than
the body,
65 days
is needed
eliminate
Catshave
*Some CONVENIA
Table
cats may
experienced
one approximately
adverse reaction
or more
than to
one
(Time
Relative
remained
with
μg/mL
μg/mL
Isolates
Pfizer Animal Health
at 1-800-366-5288.
97% of the
administered
dose
from
the treatment
body.
experiencing
an adverse
may in cats reaction call Outcome
CONVENIA
is indicated
for during
the
of skin
infections (wounds
andreaction
abscesses)
in Fiel
occurrence
same adverse
reaction
the Animals
study.
μg/mL
to Treatment)
a glomerulopa
need tocaused
be monitored
for this duration.
by susceptible
strains of Pasteurella multocida.
CLINICAL
PHARMACOLOGY:
Four CONVENIA cases had mildly elevated post-study ALT (1 case was elevated pre-study).
At
an
exagge
Staphylococcus
Success
44
Pre-Treatment 0.12 0.25 ≤ 0.06 - 2
CONVENIA
has been
shown
an experimental
in vitro system to result in an increase in free
DOSAGE
AND
ADMINISTRATION:
No clinical
abnormalities
were
notedinwith
these findings.
Pharmacokinetics
irritation, voc
concentrations
furosemide, doxycycline, and ketoconazole. Concurrent use of these or
Disea
intermedius
Cefovecin is rapidly and completely absorbed following subcutaneous administration. Non-linear
Dogs of carprofen,
Twenty-four
CONVENIA
cases
normal
pre-study BUN
values
and
elevated
post-study
Cats
other drugs
that have
a highhad
degree
of protein-binding
(e.g.
NSAIDs,
propofol,
cardiac,
anticonvulsant,
do not increase proportionally
CONVENIA
should
be
administered
as a6 single
subcutaneous
injection
ofpre3.6
mg/lb
(8 mg/kg)
body kinetics is exhibited
Failure(plasma concentrations
4
Pre-Treatment
0.12with
- 2 dose). Cefovecin
BUN values
(37
–
39
mg/dL
post-study).
There
were
CONVENIA
cases
with
normal
and
Skin
ad
and behavioral
medications)
may compete injection
with cefovecin-binding
and
cause
adverse
reactions. if response does not undergo hepatic metabolism and the majority of a dose is excreted unchanged inCONVENIA
the
weight.
A
second
subcutaneous
of
3.6
mg/lb
(8
mg/kg)
may
be
administered
Infections
Each mL of CONVENIA reconstituted lyophile contains cefovecin sodium equivalent to 80 mg mildly to moderately elevated post-study creatinine values. Two of these cases also had an
and 60 mg/kg
Skin
urine. Elimination also occurs from excretion of unchanged drug in the bile. Cefovecin is a highly
Coombs’
testabnormalities
results
and were
false
positive
reactions
forindividual
glucose dog
in should
the take Streptococcus
todirect
therapy
isNo
notclinical
complete.
The decision
for anoted
second
injection
for any
post-study
BUN.
with
these
findings.
cefovecin, methylparaben 1.8 mg (preservative), propylparaben 0.2 mg (preservative), sodium elevatedPositive
Success
16plasma (98.5%)
Pre-Treatment
≤ 0.06 ≤(99.8%)
0.06 ≤and
0.06may compete with
for a totalInfect
of 5
protein-bound
molecule
in
dog
and
cat
plasma
urine
have
been
reported
during
treatment
with
some
cephalosporin
antimicrobials.
into
consideration
such
factors
as
progress
toward
clinical
resolution,
the
susceptibility
of
the
citrate dihydrate 5.8 mg and citric acid monohydrate 0.1 mg, sodium hydroxide or hydrochloric One CONVENIA-treated cat in a separate field study experienced diarrhea post-treatment
and the incide
(Group
G) protein-bound drugs for plasma protein-binding sites that could result in transient,
other
highly
Cephalosporin
antimicrobials
may
causeoffalsely
elevated
urine protein
determinations.
causative
organisms, and
thealso
integrity
the dog’s
host-defense
mechanisms.
Therapeutic drug canis
acid as required to adjust pH.
values for all th
lasting 42
days.
The diarrhea resolved.
Failure
2 of either
Pre-Treatment
≤ 0.06
concentrations
compound. Pharmacokinetic
parameters following
Some
antimicrobials,
including
cephalosporins,
can causeforlowered
albumin
values due
to
concentrations
after the first
injection are maintained
7 days for
S. intermedius
infections
and higher free drug
EFFEC
(all means
rem
INDICATIONS:
FOREIGN
MARKET
The
following
adverseMaximum
events were
reported
voluntarily
interference
with
testing
methods.
for 14EXPERIENCE:
dayscertain
for S. canis
(Group
G) infections.
treatment
should
not exceed 2 injections.
Cats subcutaneous dosing at 8 mg/kg in the dog and cat are summarized in Table 4.
values inDogs
the 60
during
post-approval
use
of
the
product
in
dogs
and
cats
in
foreign
markets:
death,
tremors/
Dogs
Cats Cefovecin
plasma
concentrations in the
cat have been
characterized
by the
use of PPK data.
Table
4: Pharmacokinetic
Parameters
Reflecting
Total Drug
Concentrations
in Plasma
Occasionally,
Cats cephalosporins and NSAIDs have been associated with myelotoxicity, thereby creating
periods.
Inject
In
a
d
anaphylaxis,
acute
edema,
facial
edema,
injection
site
reactions
4
CONVENIA is indicated for the treatment of skin infections (secondary superficial pyoderma, ataxia, seizures,
The
MIC
values
for cefovecin
against
Pasteurella
multocida
from
skin infections
Plasma
cefovecin
concentration
data
pooled
from 4isolated
laboratory
pharmacokinetic
(mean
± standard
deviation
orwere
range)
Following
an 8 mg/kg
Intravenous
or studies.
Subcutaneous
a toxic neutropenia
.should
Other
hematological
reactions
seen with
cephalosporins
include
neutropenia,
CONVENIA
bepulmonary
administered
as a single,
one-time
subcutaneous
injection
at
a dose
of
related manne
effecti
scabs,
necrosis,
and erythema),
hemolytic
salivation,
pruritus,
lethargy,
abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius (alopecia,
(wounds
abscesses)
in cats
enrolled
a 2001-2003
field 22effectiveness
study arefrom the interstitial
Theand
finalDose
dataset
contained
concentration
records from
cats. The simulations
of Cefovecin
in338
Dogs
andin
Cats.
anemia,
hypoprothrombinemia,
prolonged
time
(PT) andconcentrations
partial
3.6
mg/lb (8 mg/kg)
bodythrombocytopenia,
weight.
After ananemia,
injection
ofprothrombin
CONVENIA,
therapeutic
fibrow
dogs
th
th
vomiting,
diarrhea,
and
inappetance.
and Streptococcus canis (Group G).
presented
in Table
6. the
All MICs
determined
inas
accordance
the
standards.
model
provide
mean were
population
estimate
well as the with
5 and
95CLSI
percentile
of the population
thromboplastin
time (PTT),for
platelet
dysfunction7 and
increasesmultocida
in serum aminotransferases.
are maintained
approximately
daystransient
for Pasteurella
infections.
either
ofCONVENIA
total and free
cefovecin
concentrations
time.
3 displays
the predicted
free At an exaggera
For a copy
of General
theREACTIONS:
Material
Safety
Data Sheet (MSDS) or to report a suspected adverse Table 6:estimates
Cats
activea
Activity of
against
Pathogens
Isolatedover
from
CatsFigure
Treated
with CONVENIA
SD1 orupon
(Range)
ADVERSE
Dosing
Information
following
administration of 8 mg/kg body weightMEAN
to cats.±Based
these vocalization,
Animal
Health
atshould
1-800-366-5288.
CONVENIA is indicated for the treatment of skin infections (wounds and abscesses) in cats reaction call Pfizer
receiv
in beginning
Fieldplasma
Studiesconcentrations
in the US During
2001-2003.
A
sample
of
the
lesion
be
obtained
for
culture
and
susceptibility
testing
prior
to
blood
cell
coun
PARAMETER
Dogs
predicted concentrations, 95% of the feline population will have active (free) drug concentrations > the
caused by susceptible strains of Pasteurella multocida.
22 of 1
CLINICAL
PHARMACOLOGY:
antimicrobial
therapy.
Once
results
become
available,
continue
with
appropriate
therapy.
If
A total of 320 dogs, ranging in age from 8 weeks to 19 years, were included in a field study MIC90 of Pasteurella multocida (0.06 μg/mL) forSample
approximately 7 days when
administered a single
INF
Dogs
Cats8p STORAGE
treatm
acceptable
response
to treatment
is notinobserved,
or if no
improvement
is and
seenthe
within
3 to 4 days,
DOSAGE AND ADMINISTRATION:
Number (See
MIC
Microbiological
Pharmacokinetics
safety analysis.
Adverse
reactions
reported
dogs treated
with
CONVENIA
active
mg/kg subcutaneous
injection of cefovecin.
MICROBIOLOGY).
Store
the
pow
MIC50 MIC90 Range
Collection
effecti
then
the diagnosis
be
and appropriate
alternative therapy
considered.
of half-life,
Disease Pathogen
Treatment
°
h
Cefovecin
is rapidly
and
completely
absorbed
following subcutaneous
administration.
Non-linear
control
are summarized
inshould
Table
2. re-evaluated
F).acU
Dogs
plasma
elimination
T1/2Relative
(h)*of
133
166 ± a18 (36° to 46the
(Time
Figure 3: Terminal
Population
Predicted
Free Concentration
Cefovecin
in± 16
Plasma Following
μg/mL
μg/mL
Isolates
Outcome
is exhibited
(plasma
concentrations
do body
not increase
with
dose).
Cefovecin
persist
the
for up toproportionally
65Reported
days. TheDuring
effect
of remaining
concentrations
μg/mL
g
p
CONVENIA should be administered as a single subcutaneous injection of 3.6 mg/lb (8 mg/kg) body kineticsTable
to Treatment)
the clie
2:CONVENIA
Number
ofmay
Dogs*
withinAdverse
Reactions
the
Field
Study
with Single Subcutaneous
Injection
of 8 mg/kg
Body Weight in Cats
line
is population
AUC0-inf (μg·h/mL)*
10400(solid
± 1900
22700 ± 3450 LIGHT. After
undergo
metabolism
the majorityantimicrobial
of a dose is excreted
unchanged
the determined.
of hepatic
cefovecin
on anyand
subsequent
therapies
has notinbeen
carton
weight. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response does notCONVENIA.
dotted
lines are the
5th57
and 95th percentiles
population
≤ 0.06
0.06prediction).
≤ 0.06 - 0.122.0 (0.5-6.0) original
(h)*h for the
6.2 ≤(0.5-12.0)
Time
of Success
maximum
concentration,
TPre-Treatment
Skin prediction,
Pasteurella
also occurs fromand
excretion
of unchanged
drug in the bile.
is a highly
Fluoroquinolone
aminoglycoside
antimicrobials
haveCefovecin
been reported
to be compatible
amber atTable
reco
to therapy is not complete. The decision for a second injection for any individual dog should take urine. Elimination
max
1,2,3
Final C
a
Infections multocida
in dog plasma
(98.5%) and
cat plasma
(99.8%) and may compete
with
with cephalosporin
antimicrobial
agents.
into consideration such factors as progress toward clinical resolution, the susceptibility of the protein-bound molecule
121 ± 51 ≤ 0.06
141 ± 12 not adversely
Maximum
concentration,
Failure
1 Cmax (μg/mL)*
Pre-Treatment
CONVENIA
Active
Control
protein-bound
drugs
for for
plasma
protein-binding
sites
thatWeight.
could result in transient,
Adverse
Reaction
causative organisms, and the integrity of the dog’s host-defense mechanisms. Therapeutic drug other highly
Table
1: Dose
Table
CONVENIA
at 8 mg/kg
Body
(n=157)
(n=163)
0.122 ± 0.011
0.090 ± 0.010 HOW SUPPLI
Vdss (L/kg)**g
higher
free
drug
concentrations
of
either
compound.
Pharmacokinetic
parameters
following
concentrations after the first injection are maintained for 7 days for S. intermedius infections and
EFFECTIVENESS:CL (mL/h/kg)**g
0.76 ± 0.13p
0.350 ± 0.40 CONVENIA
total
Typeis
Lethargy
7
subcutaneous
dosing at 8 mg/kg in the dog and cat are summarized2 in Table Volume
4.
for 14 days for S. canis (Group G) infections. Maximum treatment should not exceed 2 injections.
of CONVENIA Dogs
a lyophilized c
Weight
of Animal
Appetite
8 mL/lb)
Table 4: Anorexia/Decreased
Pharmacokinetic Parameters
Reflecting Total Drug5 Concentrations
(3.6 mg/lbinor Plasma
0.045
1
Cats
In a double-masked,
1:1 randomized
canine field study conducted in the United States, the
SD = standard
deviation
REFERENCES
range) Following an 8 mg/kg Intravenous
or Subcutaneous
CONVENIA should be administered as a single, one-time subcutaneous injection at a dose of (mean ± standard
1
effectiveness ofp =CONVENIA
was compared
to a cephalosporin
active
In provided
this study,(n=6);
320 all other data
Vomiting deviation or
6
12
SkinM(
a phase effect
was observed,
only data for the
firstcontrol.
phase are
Pillai SK,
0.23 mL
in Dogs and5 lb
Cats.
3.6 mg/lb (8 mg/kg) body weight. After an injection of CONVENIA, therapeutic concentrations Dose of Cefovecin
dogs with superficial
secondary
pyoderma,
absce
provided
are derived
from 12abscesses,
animals or infected wounds were treated with
Antibiotics
in
Diarrhea
6
7
10 lb
0.45 mL
are maintained for approximately 7 days for Pasteurella multocida infections.
either a single injection
* = SC of CONVENIA (n=157) at 3.6 mg/lb (8 mg/kg) body weight or with an oral
2005;365-440.
Blood in Feces
1
2
10.67 mL
2
15
lb
active
control
antibiotic
(n=163),
administered
twice
daily
for
14
days.
In
this
study,
dogs
could
CONV
** = IV
MEAN ± SD or (Range)
Fish DN, Cho
General Dosing Information
a
receive a second= course
of therapy
Dehydration
0
1
such a
arithmetic
mean 14 days after the initial treatment. Of the 320 enrolled dogs,
Pseudomonas
A sample of the lesion should be obtained for culture and susceptibility testing prior to beginning
20 lb
0.90 mL
PARAMETER
22 of 157 dogs hreceived
2 treatments
of CONVENIA and 35 of 163 dogs received 2 courses of
agent
= harmonic
mean
2002;50:1045-1
antimicrobial therapy. Once results become available, continue with appropriate therapy. If
Flatulence
1
40 lb
1.80 mLCatsp 0
Dogs
3
treatment with gthe
active control.
= geometric
meanIn the study, 118 of the 157 enrolled cases were evaluable for
Mayer steroi
I, Nag
acceptable response to treatment is not observed, or if no improvement is seen within 3 to 4 days,
Increased Borborygmi
1
0
80 lb
3.60 mL
effectiveness for CONVENIA, and 117 of the 163 enrolled cases were evaluable for effectiveness of
third-generat
then the diagnosis should be re-evaluated and appropriate alternative therapy considered.
h
Cats
Population
Pharmacokinetics
Terminal plasma elimination half-life, T1/2 (h)*
133 ± 16
166 ± 18
the active control antibiotic. CONVENIA was non-inferior to the active control. Table 7 summarizes
Antimicrob
*Some dogs
In aCh
d
may
have experienced
one adverse
reaction
or appropriate
more than one
CONVENIA may persist in the body for up to 65 days. The effect of remaining concentrations
PREPARATION
OF SOLUTIONmore
FORthan
INJECTION:
To
deliver
the
dose,the
aseptically
g
p
Dogsrates obtained 28 days after the initiation of the final course of therapy.
4
clinical success
AUC0-inf
(μg·h/mL)*
10400
±
1900
22700
±
3450
Birchard
SJ,
effect
occurrence
of the same
adverse
reaction
duringwater
the study.
of cefovecin on any subsequent antimicrobial therapies has not been determined.
reconstitute
CONVENIA
with
10 mL sterile
for injection. Shake and allow vial to sit until all Cefovecin plasma concentrations in the dog have been characterized by the use of population
PA: WBinfecte
Saun
Table 7:
Clinical Success Rates by Treatment Group 28 Days after the Initiation of the
(0.5-12.0)
2.0 (0.5-6.0)
Time of maximum
concentration,
Tmax (h)*hThe resulting6.2
Fluoroquinolone and aminoglycoside antimicrobials have been reported to be compatible
material
is visually dissolved.
solution
contains cefovecin
sodium equivalent
to 80
pharmacokinetic
(PPK)
data.
Plasma
cefovecin
concentration
data
were
pooled
from
7
Mild
to
moderate
elevations
in
serum

-glutamyl
transferase
or
serum
alanine
1,2,3
Final
Course
of
Therapy.
a is light sensitive. The vial should be stored in the original carton and
3.6 m
with cephalosporin antimicrobial agents.
141-2
mg/mL cefovecin.
CONVENIA
121 ± 51
141 ± 12
Maximum concentration,
Cmax (μg/mL)*
laboratory pharmacokinetic studies, each involving young, normal healthy Beagle dogs. NADA#
The at
aminotransferase
were
noted post-treatment in several of the CONVENIA-treated dogs. No
grefrigerated when not in use. Use the entire contents of the vial within 56 days of reconstitution.
final dataset contained 591 concentration records from
39 dogs. The simulations from the model onceDid
Table 1: Dose Table for CONVENIA at 8 mg/kg Body Weight.
0.122 ± 0.011
0.090 ± 0.010
Vdss (L/kg)**
clinical abnormalities were noted with these findings.
Dogs
g
p in dogs and cats with known allergy to
provide the mean population estimate and the 5th and 95th percentile of the population estimates rates w
CONTRAINDICATIONS:
CONVENIA is contraindicated
CLtotal One
(mL/h/kg)**
0.76
±
0.13
0.350
±
0.40
Type of Infection
CONVENIA-treated
dog in a(penicillins
separate field
experienced
diarrhea
post-treatment
CONVENIA
Control
of total and free cefovecin concentrations
over time. FigureActive
2 shows
the predicted free plasma Table
cefovecin or to β-lactam
and study
cephalosporins)
group
antimicrobials.
Anaphylaxis
Volume of CONVENIA
Weight of Animal
lasting 4 weeks.
diarrhea
resolved.
Di
(n=118)
(n=117)
of 8 mg/kg body weight
to dogs. Based upon these
beenThe
reported
with
the use of this product in foreign market experience. If an allergic concentrations following administration
(3.6 mg/lb or 0.045 mL/lb)
1
SD = standardhas
deviation
predicted concentrations, 95% of the canine population will have active (free) drug concentrations
Ne
reaction
or
anaphylaxis
occurs,
CONVENIA
should
not
be
administered
again
and
appropriate
p
Skin
(secondary
superficial
pyoderma,
= a phase
was observed, only data for the first phase are provided (n=6); all other data
5 lb
0.23 mL
Catseffect
MICROBIOLOGY:
CONVENIA
is(0.06a μg/mL)
cephalosporin
antibiotic.
Like
other
β-lactam
>
the
MIC
of
S.
canis
for
approximately
14
days
and
free
concentrations
109
(92.4%)
108
(92.3%)
Type
therapy
should
be
instituted.
Anaphylaxis
may
require
treatment
with
epinephrine
and
other
90
and
wounds)
provided
animals
A are
totalderived
of
291 from
cats,12
ranging
in age
from 2.4oxygen,
months intravenous
(1 cat) to 21 years,
includedantihistamine,
in abscesses,
the antimicrobials,
CONVENIA
exerts its (0.25
inhibitory
by interfering
withfollowing
bacteriala single
10 lb
0.45 mL
> infected
the MIC
for S. intermedius
μg/mL) effect
for approximately
7 days
emergency
measures,
including
fluids, were
intravenous
90
* = SC field study
safety analysis.
reported
in cats treated
withAdverse
CONVENIA
and may
cell wall
synthesis.
This interference
is primarily(See
dueMICROBIOLOGY).
to its covalent binding to the
8 mg/kg
subcutaneous
injection of cefovecin.
corticosteroids,
andAdverse
airway reactions
management,
as clinically
indicated.
reactions
15 lb
0.67 mL
CONVENIA
was
administered
concomitantly
other commonly
used carboxypeptidase),
veterinary products which
** = IV the active
control
are summarized
Table
penicillin-binding
proteins
(PBPs) with
(ie, transpeptidase
and
require
prolonged
treatmentindue
to 3.
the prolonged systemic drug clearance (65 days).
a
Figurepreventatives,
2:forPopulation
Free
Concentration
of Cefovecin
in Plasma
such asare
heartworm
flea
control
products,
Skin (
= arithmetic mean
20 lb
0.90 mL
essential
synthesisPredicted
of the
bacterial
cell sedatives/tranquilizers,
wall. For
E. coli, the
inanesthetic
vitroFollowing
activity ofa Single
Table mean
3:WARNINGS:
Number ofNot
Cats*
withinAdverse
Reactions
Reported
During
the
Field
Study with
h
Subcutaneous
Injection
of 8 mg/kg
Bodyhormone
Weight
insupplementation,
Dogsto(solid
isand
population
prediction,
agents,
routine
immunizations,
antihistamines,
thyroid
non-protein=
harmonic
for
use
humans.
Keep
this
and
all
drugs
out
of
reach
of
children.
Consult
a
CONVENIA
is
comparable
to
other
cephalosporins,
but
due
the line
high-affinity
40 lb
1.80 mL
CONVENIA.
g
dotted
are
theduring
5thconcentration
andthe
95thfield
percentiles
for the population
steroidal
anti-inflammatory
drugs
study.
CONV
= geometric
mean
physician in case of accidental human exposure. For subcutaneous use in dogs and
cats only.
binding,
the lines
in vivo
free
of cefovecin
does notprediction).
reach the MIC90 for
Antimicrobial
80 lb for Subcutaneous Injection in Dogs and
3.60Cats
mL Only
heartw
Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions
coli (1.0 μg/mL). CONVENIA is not active against Pseudomonas spp. or enterococci.
Cats E. in
Population Pharmacokinetics
CONVENIA
Activethose
Control
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
and va
sensitized
individuals. To minimize the possibility
of allergic reactions,
handling
such
Adverse
Reaction
In a double-masked,
1:1 randomized cat field study conducted in the United States, the
PREPARATION OF SOLUTION FOR INJECTION: To deliver the appropriate dose, aseptically Dogs
Dogs
(n=147)
(n=144)
antimicrobials, including cefovecin, are advised
to avoid direct contact
of the product
with
DESCRIPTION:
sodium
a semi-synthetic
broad-spectrum
antibacterial
agent
the
effectiveness
of CONVENIA
was
compared to
an active
control.
In thisagainst
study, label-claim
291 cats with
ANIM
reconstitute
CONVENIACefovecin
with 10 mL
sterileiswater
for injection.
Shake and allow
vial to sit until
allfromCefovecin
The
minimum
inhibitory
concentration
(MIC)
values
for
cefovecin
pathogens
plasma
concentrations
in
the
dog
have
been
characterized
by
the
use
of
population
the skin and mucous membranes.
cephalosporin
class
of
chemotherapeutic
agents.
Cefovecin
is
the
non-proprietary
designation
for
Vomiting
10
14
infected
wounds
or
abscesses
were
treated
with
either
a
single
injection
of
CONVENIA
(n=147)
Dogs
material is visually dissolved. The resulting solution contains cefovecin sodium equivalent to 80 pharmacokinetic (PPK) data. Plasma cefovecin concentration data were pooled from 7
isolated from skin infections in dogs enrolled in a 2001-2003 field effectiveness study are presented
(6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[(2S)-tetrahydro-2at
mg/lb
(8 mg/kg)
body
weight
or with an oral
active control
antibiotic
(n=144),
administered
CONV
PRECAUTIONS:
Prescribing
antibacterial
drugs
the absence
of
a26proven
or 3.6
strongly
7 inhealthy
mg/mL cefovecin.
CONVENIA is light sensitive. The vial should be stored in the original carton and laboratoryDiarrhea
in
Table
5.
All
MICs
were
determined
in
accordance
with
the
Clinical
and
Laboratory
Standards
pharmacokinetic
studies,
each
involving
young,
normal
Beagle
dogs.
The
furanyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid, monosodium
salt.
once
daily
for 14(CLSI)
days.standards.
CONVENIA was non-inferior to the active control. The clinical success
and 60
suspected
bacterial
infection
is
unlikely
to
provide
benefit
to
treated
animals
and
may
refrigerated
when not in use. Use the entire contents of the vial within
56 days of reconstitution.
Institute
final dataset
contained
591
concentration
records
from
39
dogs.
The
simulations
from
the
model
Anorexia/Decreased Appetite
6
6
rates were obtained 28 days after the initiation of therapy and are presented in Table 8.
a total
increase
the risk
of theand
development
of thdrug-resistant
animal pathogens.
Figure 1: Chemical
structureisofcontraindicated
cefovecin sodium.
mean
population
estimate
the 5th and 95
percentile
CONTRAINDICATIONS:
CONVENIA
in dogs and cats with known allergy to provide the
Table 5: Activity of CONVENIA against Pathogens Isolated from Dogs Treated with CONVENIA
Lethargy
6 of the population estimates
6
vomitin
Clinical
Success
Rates
Treatment
Group 28 Days after the Initiation of Therapy.
cefovecin
concentrations
time.
2 shows
predicted
free
plasma
safe use
of CONVENIAover
in dogs
orFigure
cats less
than 4the
months
of age
(see
Animal Table
Safety)8:in
and
cefovecin or to β-lactam (penicillins and cephalosporins) group antimicrobials. Anaphylaxis of total and freeThe
Field Studies
in the
USby
During
2001-2003.
site irr
Hyper/Acting
Strange
1
1
concentrations
following
administration
of
8
mg/kg
body
weight
to
dogs.
Based
upon
these
in
breeding
or
lactating
animals
has
not
been
determined.
Safety
has
not
been
established
has been reported with the use of this product in foreign market experience. If an allergic
with re
Cats
of the canine The
population
will have
active
(free) drug
concentrations
for IM or Urination
IV95%
administration.
long-term
effects
sites
have not
Inappropriate
1on injection
0 been determined.
reaction or anaphylaxis occurs, CONVENIA should not be administered again and appropriate predicted concentrations,
lasting
MIC
Microbiological Number Sample
S. canis (0.06
μg/mL)
for approximately
14 days
and free 65
concentrations
is slowly
eliminated
from the body,
approximately
days is needed toType
eliminate
MIC
Collection
MIC
of Disease
Infection Pathogen
therapy should be instituted. Anaphylaxis may require treatment with epinephrine and other > the MIC90 ofCONVENIA
Active Control
50
90 Range
remain
of
Treatment CONVENIA
*Somefor
cats
may
experienced
more
than
oneAnimals
adverse
reaction
oranamore
thanreaction
one may
> the MIC
S. of
intermedius
(0.25 μg/mL)
for the
approximately
7 days
following
single
97%
the have
administered
dose from
body.
experiencing
adverse
(cefovecin sodium)
(cefovecin sodium)
mg/kg subcutaneous injection of cefovecin. (See MICROBIOLOGY).
ent from8the
may
> the inhibitory
MIC90 forconcentration
S. intermedius
(0.25
μg/mL)
for approximately
7 days following
The minimum
(MIC)
values
for cefovecin
against label-claim
pathogensa single
emergency measures, including oxygen, intravenous
intravenous
antihistamine,
signationFigure
for 2: Population
Vomiting
10in Plasmafluids,
14
Predicted Free
of Cefovecin
FollowingAdverse
a Single
Skin (wounds
abscesses)
80 (90.9%)
mg/kg
injection
of 86
cefovecin.
(Seefield
MICROBIOLOGY).
isolated8and
from
skinsubcutaneous
infections in dogs
enrolled
in(96.6%)
a 2001-2003
effectiveness
study are presented
corticosteroids,
and Concentration
airway management,
as clinically
indicated.
reactions
may
trahydro-2Injection
of 8 mg/kg
Body Weight
inthe
Dogs
(solid7 line
is population
prediction,
Diarrhea
26 (65 days). in TableFigure
lt a Subcutaneous
5.
All
MICs
were
determined
in
accordance
with
the
Clinical
and
Laboratory
Standardsa Single
require
prolonged
treatment
due
to
prolonged
systemic
drug
clearance
2:
Population
Predicted
Free
Concentration
of
Cefovecin
in
Plasma
Following
are the 5th and 95th Appetite
percentiles for the population prediction).
CONVENIA
was
usedstandards.
concomitantly
with
commonly
used in
veterinary
products
as prediction,
only. dotted lines
Institute
(CLSI)
Anorexia/Decreased
Subcutaneous
Injection
of 8other
mg/kg
Body Weight
Dogs (solid
line is such
population
WARNINGS: Not for use in humans. Keep this and6 all drugs out of reach of6 children.heartworm
Consult
a preventatives,
fleathe
control
products,
sedatives/tranquilizers,
anesthetic
agents,
ns in
dotted
lines
are
5th and
95th Pathogens
percentiles
for the population
prediction).
Table
5:
Activity
of
CONVENIA
against
Isolated
from
Dogs
Treated
with
CONVENIA
physician
in
case
of
accidental
human
exposure.
For
subcutaneous
use
in
dogs
and
cats
only.
Lethargy
6
6
and vaccines during the field study.
uch
in
Field
Studies
in
the
US
During
2001-2003.
Antimicrobial
drugs, including penicillins and cephalosporins,
can cause1allergic reactions in
Hyper/Acting
Strange
1
with
ANIMAL
SAFETY:
sensitized individuals. To minimize the possibility of allergic reactions, those handling
such
Dogs with
Inappropriate
Urination
Sample
antimicrobials,
including cefovecin, are advised1 to avoid direct contact0of the product
Number
MIC
Microbiological
CONVENIA
administered
to healthy 4-month-old
at doses of
12 mg/kg (1.5X),MIC
36 mg/kg
Collection
MIC(4.5X),
ngly
the skin and mucous membranes.
50
90 Range
of
Disease
Pathogen
Treatment dogs
*Some cats may have experienced more than one adverse reaction or more than and
one
(Time
Relative
60 mg/kg (7.5X) every
7 days by dorsoscapular
subcutaneous
injections
was well-tolerated
for
may
μg/mL
μg/mL
Isolates
Outcome
PRECAUTIONS:
Prescribing
antibacterial
drugs
in
the
absence
of
a
proven
or
strongly
occurrence of the same adverse reaction during the study.
μg/mL
to Treatment)
a total of 5 doses. Vomiting and diarrhea were seen in all treatment
groups, with the incidence of
suspected bacterial infection is unlikely to provide benefit to treated animalsvomiting
and may
and the incidence and duration of diarrhea increasing in a dose-related manner. Injection
Four CONVENIA
cases
mildly
elevated post-study
ALT (1 animal
case was
elevated pre-study).
and
increase the
riskhad
of the
development
of drug-resistant
pathogens.
Staphylococcus
Success
44 frequency
Pre-Treatment
0.12 manner
0.25 and
≤ 0.06 - 2
site irritation and transient
edema occurred
with increasing
in a dose-related
No clinical abnormalities were noted with these findings.
hed
The safe use of CONVENIA in dogs or cats less than 4 months of age (see Animal with
Safety)
andinjections.
repeat
Two injection site reactions included a seroma over the shoulder and swelling
intermedius
ned.
Twenty-four
CONVENIA
cases had
normal
pre-study
BUN values Safety
and elevated
post-study
in
breeding
or
lactating
animals
has
not
been
determined.
has
not
been
established
lasting
>
30
days.
Dogs
dosed
at
36
mg/kg
had
a
significant
(P=0.0088)
increase
in
BUN
(all
means
Failure
4
Pre-Treatment
0.12 - 2
nate
BUN values
mg/dL post-study).
There were
6 CONVENIA
cases
with
normal
pre-determined.
and
Skin
for IM(37
or–IV39administration.
The long-term
effects
on injection
sites
have
not been
remained
within the normal range) compared to the controls. One dog dosed at 60 mg/kg exhibited
may
moderatelyis elevated
post-study
creatinine
values.
Two of these
cases
also hadto
Infectionson histopathology, and 1 dog in this same group had minimal peliosis hepatis.
nt to 80 mg mildly toCONVENIA
slowly eliminated
from
the body,
approximately
65 days
is needed
eliminate
a an
glomerulopathy
post-study
BUN. No clinical
noted
with these findings.
ve), sodium elevated97%
Streptococcus Success
16
Pre-Treatment ≤ 0.06 ≤ 0.06 ≤ 0.06
of the administered
dose abnormalities
from the body.were
Animals
experiencing
an adverse reaction
may
At an exaggerated dose of 180 mg/kg (22.5X) in dogs, CONVENIA caused some injection site
ydrochloric
free
One CONVENIA-treated
cat in
separate
field study experienced diarrhea post-treatment
need to be monitored
forathis
duration.
canis
(Group
G) Edema resolved within 8-24 hours.
irritation, vocalization,
and
edema.
e or
lasting 42
days. Thehas
diarrhea
resolved.
Failure
2
Pre-Treatment
≤ 0.06
CONVENIA
been shown
in an experimental in vitro system to result in an increase
Cats in free
sant,
FOREIGN
MARKET EXPERIENCE:
The following
adverse and
events
were reported
voluntarily
concentrations
of carprofen, furosemide,
doxycycline,
ketoconazole.
Concurrent
useCONVENIA
of these oradministered to healthy 4-month-old cats at doses of 12 mg/kg (1.5X), 36 mg/kg (4.5X),
during post-approval
ofathe
in protein-binding
dogs and cats(e.g.
in foreign
markets:
tremors/
other drugs thatuse
have
highproduct
degree of
NSAIDs,
propofol,death,
cardiac,
anticonvulsant,
Cats
and 60 mg/kg (7.5X) every 7 days by dorsoscapular subcutaneous injections was well-tolerated
the
anaphylaxis,
acute
pulmonary
edema,
facial edema,and
injection
site reactions
and behavioral
medications)
may
compete with
cefovecin-binding
cause adverse
reactions.
pyoderma, ataxia, seizures,
The
values
for cefovecin
against
Pasteurella
multocida
isolated
from
skin infections
for a total
of MIC
5 doses.
Vomiting
and diarrhea
were observed
in cats,
with the
incidence
of vomiting
als.
(alopecia,
scabs,direct
necrosis,
and erythema),
hemolytic
anemia,
salivation,
pruritus,
ntermedius
and
abscesses)
in cats
enrolledin in
a 2001-2003manner.
field effectiveness
study are
Positive
Coombs’
test results
and false
positive
reactions
for lethargy,
glucose
in (wounds
the
and the
incidence
and duration
of diarrhea
increasing
a dose-related
The mean albumin
ons.
vomiting,
diarrhea,
and
inappetance.
presented
in Table 6. All MICs
accordance
standards.
urine have been reported during treatment with some cephalosporin antimicrobials.
values for
all the CONVENIA-treated
catswere
weredetermined
significantlyinlower
(P ≤ 0.05)with
thanthe
the CLSI
control
values
e to
For a copy
of the Material
Safety Data
(MSDS)
or to
report urine
a suspected
adverse
Cephalosporin
antimicrobials
may Sheet
also cause
falsely
elevated
protein determinations.
(all means
remained
within
the normal range)
forPathogens
all time periods.
Thefrom
mean
alkaline
phosphatase
Table
6: Activity
of CONVENIA
against
Isolated
Cats
Treated
with CONVENIA
Cats reactionSome
call Pfizer
Animal Health
at 1-800-366-5288.
antimicrobials,
including
cephalosporins, can cause lowered albumin values
due
to
values
ininthe
60 mg/kg
group
were
higher (P ≤ 0.0291) than the control values for all time
ses) in cats
Field
Studies
in the
USsignificantly
During 2001-2003.
plasma
concentrations
in the cat
havemethods.
been characterized by the use of PPK data. periods. Injection-site
ating Cefovecin
interference
with certain
testing
Cats irritation and transient edema occurred with increasing frequency in a doseCLINICAL
PHARMACOLOGY:
concentration data were pooled from 4 laboratory pharmacokinetic studies. related manner Cefovecin
enia, Plasma cefovecin
and with repeat
injections.
One cat ininthe
mg/kg
group
hadcharacterized
a mild renal tubular
and
Sample
plasma
concentrations
the12cat
have
been
by the
use of PPK data.
Occasionally,
cephalosporins
and
NSAIDs
have
been
associated
with
myelotoxicity,
thereby
creating
Number
MIC
dataset contained 338 concentration
records from 22 cats. The simulations from the interstitial fibrosis,
Pharmacokinetics
artial The final
and
1cefovecin
cat in theMicrobiological
12
mg/kg group had
glomerulosclerosis
on
histopathology.
MIC
Collection
MIC
4
Plasma
concentration
data
were
pooled from 4 laboratory
pharmacokinetic
studies.
50
90 Range
a toxic
neutropenia
th
.estimate
Other hematological
reactions
seen
with cephalosporins
include
neutropenia,
of mild
Disease
Pathogen
Treatment
model provide
the
mean
population
as well asfollowing
the
5th and
95
percentile
of the population
Cefovecin
is
rapidly
and completely
absorbed
subcutaneous
administration.
Non-linear
es.
(Time
Relative
finalofdataset
contained
338 concentration
records
from
22 cats.
The
simulations from the
μg/mL
μg/mL
anemia,
hypoprothrombinemia,
thrombocytopenia,
prolonged
prothrombin
time
(PT) At
and
partial Thedose
an exaggerated
180 mg/kg
(22.5X), CONVENIA
was associated
with
injection
site
irritation,
Isolates
Outcome
estimates
of
total
and
free
cefovecin
concentrations
over
time.
Figure
3
displays
the
predicted
free
kinetics
is
exhibited
(plasma
do
not
increase
proportionally
with
dose).
Cefovecin
μg/mL
th
mg/kg) body
to day
Treatment)
model
provide
theresolved
mean population
estimate
as
well10,
as cats
the 5had
and
95th percentile
of the population
thromboplastin
time
(PTT),
platelet
dysfunction
and
transient
increases
in
serum
aminotransferases.
vocalization,
and
edema.
Edema
within
8-24
hours.
On
lower
mean
white
plasma does
concentrations
following
of 8 the
mg/kg
body weight
to cats.
Based upon
these in the
not undergo
hepaticadministration
metabolism and
majority
of a dose
is excreted
unchanged
if response
estimates
of to
total
free cefovecin
concentrations
over
displays
free
blood cellSkin
counts
compared
theand
controls.
One cat57
had
a small
amount
oftime.
bilirubinuria
on
day 10.
Success
Pre-Treatment
≤Figure
0.06 3≤
0.06
≤ the
0.06predicted
- 0.12
Pasteurella
concentrations,
of
the feline
active (free)
concentrations
> the
Elimination
also
occurs
frompopulation
excretionwill
of have
unchanged
drugdrug
in the
bile. Cefovecin
is a highly
ADVERSE95%
REACTIONS:
should predicted
take urine.
plasma
concentrations following administration of 8 mg/kg body weight to cats. Based upon these
udy
Infections
multocida
Pasteurella
μg/mL)
for approximately
7 days
when(99.8%)
administered
a single
8 with
molecule(0.06
in dog
plasma
(98.5%) and cat
plasma
and may
compete
STORAGE
INFORMATION:
bility ofMIC
the90 ofprotein-bound
Failure 95% of the1feline population
Pre-Treatment
≤ °0.06
Dogsmultocida
predicted
concentrations,
will
have
active
(free)
drug
concentrations
>
the
°
tive drug
mg/kg subcutaneous
injection
of cefovecin.
MICROBIOLOGY).
other highly
protein-bound
drugs
for(See
plasma
protein-binding
that could
in transient,
the
powder
reconstituted
product
the original
carton, refrigerated
at 2 administered
to 8 C
peutic
A total
of 320 dogs,
ranging
in
age
from
8 weeks tosites
19 years,
wereresult
included
in aStore
field
study
MICand
ofthe
Pasteurella
multocida
(0.06inμg/mL)
for approximately
7 days when
a single 8
°
°
90 entire contents of the vial within 56 days of reconstitution. PROTECT FROM
free
drug
concentrations
of either compound.
parameters
46EFFECTIVENESS:
F). Use
the
ectionsFigure
and higher
3: Population
Predicted
Free Concentration
of Cefovecin
in Plasma
Following
a and(36
safety
analysis.
Adverse
reactions
reported
inPharmacokinetic
dogs treated
with
CONVENIAfollowing
thetoactive
mg/kg
subcutaneous injection of cefovecin. (See MICROBIOLOGY).
subcutaneous
dosing
at
8
mg/kg
in
the
dog
and
cat
are
summarized
in
Table
4.
LIGHT.
After
each
use
it
is
important
to
return
the
unused
portion
back
to
the
refrigerator
in
the
injections.
with
Single Subcutaneous
Injection
of 8 mg/kg
Body
control are
summarized
in Table
2. Weight in Cats (solid line is population
Population
PredictedtheFree
Cefovecin
inclear
Plasma
original Dogs
carton.Figure
As with3:other
cephalosporins,
colorConcentration
of the solutionofmay
vary from
to Following a
prediction,
dotted
lines
the 5thofand
95th percentiles
for Reactions
theTotal
population
prediction).
Table
4:Table
Pharmacokinetic
Parameters
Reflecting
Drug
Concentrations
Plasma
Inreconstitution
a double-masked,
1:1darken
randomized
canine
study
conducted
in Cats
the United
States,
the
2: are
Number
Dogs*
with Adverse
Reported
During theinField
Study at
with
Single Subcutaneous
Injection
ofIf stored
8 field
mg/kg
Body
Weight in
(soliddoes
line is population
amber
and may
over time.
as
recommended,
solution
color
standard deviation or range) Following an 8 mg/kg Intravenous or Subcutaneous
th
at a dose of (mean ±CONVENIA.
effectiveness
of CONVENIA
wasare
compared
to a95cephalosporin
In this
study, 320
prediction,
dotted lines
the 5th and
percentiles active
for thecontrol.
population
prediction).
not adversely
affect
potency.
centrations Dose of Cefovecin in Dogs and Cats.
dogs with superficial secondary pyoderma, abscesses, or infected wounds were treated with
HOW
SUPPLIED:
CONVENIA
Active Control either a single injection of CONVENIA (n=157) at 3.6 mg/lb (8 mg/kg) body weight or with an oral
Adverse Reaction
CONVENIA
available
as a 10(n=163),
mL multi-use
vial containing
cefovecin
as could
activeis control
antibiotic
administered
twice daily800
formilligrams
14 days. Inofthis
study, dogs
(n=157)± SD1 or (Range)(n=163)
MEAN
a lyophilized
cake.
receive
a second course of therapy 14 days after the initial treatment. Of the 320 enrolled dogs,
o beginning
PARAMETER
Lethargy
2
7 REFERENCES:
22 of 157 dogs received 2 treatments of CONVENIA and 35 of 163 dogs received 2 courses of
therapy. If
p
Dogs5
Cats 8 1Pillai SK,
treatment
with the
control. GM.
In theAntimicrobial
study, 118 of the
157 enrolled cases
wereV,evaluable
for
Anorexia/Decreased Appetite
Moellering
RC,active
Eliopoulos
combinations.
In: Lorian
ed.
3 to 4 days,
effectiveness
for CONVENIA,
the 163 enrolled
were evaluable
of
Antibiotics
in laboratory
medicine.and
5th 117
ed.ofPhiladelphia,
PA:cases
Lippincott
Williams for
& effectiveness
Wilkins,
ered.
TerminalVomiting
plasma elimination half-life, T1/2 (h)*h
133 ± 616
166 ± 18 122005;365-440.
the active control antibiotic. CONVENIA was non-inferior to the active control. Table 7 summarizes
centrations
Diarrhea g
6 p
theChoi
clinical
success
rates
obtained
28 days
after the initiation
offluoroquinolones
the final course ofagainst
therapy.
AUC0-inf (μg·h/mL)*
10400 ± 1900
22700 ± 34507 2Fish DN,
MK,
Jung
R.
Synergic
activity
of
cephalosporins
plus
determined.
in Feces
1
with resistance
one or both
drugs.
Antimicrob
Table 7:aeruginosa
Clinical Success
Rates bytoTreatment
Group
28 JDays
after theChemother
Initiation of the
6.2 (0.5-12.0)
2.0 (0.5-6.0)2 Pseudomonas
Time of Blood
maximum
concentration, Tmax (h)*h
compatible
2002;50:1045-1049.
Course of Therapy.
Dehydration
121 ± 051
141 ± 12 1 3MayerFinal
Maximum
concentration, Cmax (μg/mL)*a
I, Nagy E. Investigation of the synergic effects of aminoglycoside-fluoroquinolone and
Flatulence
1
g
0.122 ± 0.011
0.090 ± 0.0100 third-generation cephalosporin combinations against clinical isolates of Dogs
Vdss (L/kg)**
Pseudomonas spp. J
Increasedg Borborygmi
1 p
1999;43:651-657.
CLtotal (mL/h/kg)**
0.76 ± 0.13
0.350 ± 0.400 Antimicrob
TypeChemother
of Infection
4
CONVENIA
Active Control
Birchard SJ, Sherding RG. Saunders manual of small animal
practice. 2nd ed. Philadelphia:
*Some dogs may have experienced more than one adverse reaction or more than one
(n=118)
(n=117)
)
1
PA: WB Saunders Co, 2000;166.
SD = standard
deviation
occurrence
of
the
same
adverse
reaction
during
the
study.
p
nine
Skin (secondary
superficial
= a phase effect was observed, only data for the first phase are provided (n=6); all other data
NADA# 141-285,
Approved
by FDA pyoderma,
109 (92.4%)
108 (92.3%)
No
abscesses,
and
infected
wounds)
provided
are
derived
from
12
animals
Mild to moderate elevations in serum -glutamyl transferase or serum alanine
* = SC aminotransferase were noted post-treatment in several of the CONVENIA-treated dogs. NoDistributed by:
CONVENIA was administered concomitantly with other commonly used veterinary products
** = IV clinical abnormalities were noted with these findings.
ment
a
suchDiv.
as of
heartworm
anesthetic
= arithmetic mean
Pfizer Inc preventatives, flea control products, sedatives/tranquilizers,
Revised June 2011
One CONVENIA-treated
dog in a separate field study experienced diarrhea post-treatment
h
agents,
immunizations,
antihistamines, thyroid hormone supplementation,
and non= harmonic
mean
11892301
Newroutine
York, NY
10017
lasting
4 weeks. The
resolved. antibiotic. Like other β-lactam
g
MICROBIOLOGY:
CONVENIA
is diarrhea
a cephalosporin
steroidal
anti-inflammatory
drugs during the field study.
= geometric
mean
the antimicrobials, CONVENIA exerts its inhibitory effect by interfering with bacterial
Cats
Population
Pharmacokinetics
and cell wall synthesis. This interference is primarily due to its covalent binding to the
In a double-masked, 1:1 randomized cat field study conducted in the United States, the
aseptically
Dogs
penicillin-binding
proteins (PBPs) (ie, transpeptidase and carboxypeptidase), which
effectiveness of CONVENIA was compared to an active control. In this study, 291 cats with
o sit until
all essential
Cefovecin
concentrations
in thecell
dog wall.
have been
theactivity
use of population
are
for plasma
synthesis
of the bacterial
For E.characterized
coli, the in by
vitro
of
with
infected wounds or abscesses were treated with either a single injection of CONVENIA (n=147)
valent to
80
pharmacokinetic
(PPK)
data.
Plasma
cefovecin
concentration
data
were
pooled
from
7
CONVENIA is comparable to other cephalosporins, but due to the high-affinity proteincartonbinding,
and laboratory
pharmacokinetic
studies, each
involving young,
normal
healthy
dogs. The at 3.6 mg/lb (8 mg/kg) body weight or with an oral active control antibiotic (n=144), administered
the in vivo
free concentration
of cefovecin
does not
reach
the Beagle
MIC90 for
nstitution.
finalμg/mL).
datasetCONVENIA
contained 591
concentration
records
from 39 dogs.
simulations from the model once daily for 14 days. CONVENIA was non-inferior to the active control. The clinical success
E. coli (1.0
is not
active against
Pseudomonas
spp.The
or enterococci.
rates were obtained 28 days after the initiation of therapy and are presented in Table 8.
n allergy
to provide the mean population estimate and the 5th and 95th percentile of the population estimates
Dogs
of totalinhibitory
and free concentration
cefovecin concentrations
over
time. Figure
2 shows
the predicted
free plasma Table 8: Clinical Success Rates by Treatment Group 28 Days after the Initiation of Therapy.
Anaphylaxis
The minimum
(MIC) values
for
cefovecin
against
label-claim
pathogens
concentrations
following
administration
of
8
mg/kg
body
weight
to
dogs.
Based
upon
these
an allergic
isolatedpredicted
from skin concentrations,
infections in dogs95%
enrolled
in
a 2001-2003
field effectiveness
study
presented
Cats
of the
canine
population
haveand
active
(free)are
drug
concentrations
appropriate
in Table>5.the
All MICs
determined in
accordance
with the will
Clinical
Laboratory
Standards
MIC90were
of S. canis (0.06 μg/mL) for approximately 14 days and free concentrations
Type of Infection
e and other
CONVENIA
Active Control
Institute (CLSI) standards.
ihistamine, > the MIC90 for S. intermedius (0.25 μg/mL) for approximately 7 days following a single
(n=89)
(n=88)
of CONVENIA injection
against Pathogens
Isolated
from Dogs Treated with CONVENIA
mg/kg subcutaneous
of cefovecin.
(See MICROBIOLOGY).
ctions Table
may 5:8Activity
Studies
the US During
2001-2003.
ys). in FieldFigure
2: in
Population
Predicted
Free Concentration of Cefovecin in Plasma Following a Single
Skin (wounds and abscesses)
86 (96.6%)
80 (90.9%)
of 8 mg/kg Body Weight
in Dogs (solid line is population prediction,
. Consult a Subcutaneous Injection
Sample
th
Number
and 95th percentiles
for Collection
the population prediction).
CONVENIA was used concomitantly with other commonly used veterinary products such as
d cats only. dotted lines are the 5Microbiological
MIC50 MIC90 MIC
of
Pathogen
Treatment
heartworm preventatives, flea control products, sedatives/tranquilizers, anesthetic agents,
eactionsDisease
in
one
(Time Relative μg/mL μg/mL Range
Isolates
Outcome
and vaccines during the field study.
ndling such
μg/mL
to Treatment)
oduct
with
ANIMAL SAFETY:
dy).
Staphylococcus Success
44
Pre-Treatment 0.12 0.25 ≤ 0.06 - 2
Dogs
CONVENIA administered to healthy 4-month-old dogs at doses of 12 mg/kg (1.5X), 36 mg/kg (4.5X),
intermedius
or
strongly
udy
and 60 mg/kg (7.5X) every 7 days by dorsoscapular subcutaneous injections was well-tolerated for
Skin (wounds and abscesses)
(n=89)
(n=88)
86 (96.6%)
80 (90.9%)
CONVENIA was used concomitantly with other commonly used veterinary products such as
heartworm preventatives, flea control products, sedatives/tranquilizers, anesthetic agents,
and vaccines during the field study.
ANIMAL SAFETY:
Dogs
CONVENIA administered to healthy 4-month-old dogs at doses of 12 mg/kg (1.5X), 36 mg/kg (4.5X),
and 60 mg/kg (7.5X) every 7 days by dorsoscapular subcutaneous injections was well-tolerated for
a total of 5 doses. Vomiting and diarrhea were seen in all treatment groups, with the incidence of
vomiting and the incidence and duration of diarrhea increasing in a dose-related manner. Injection
site irritation and transient edema occurred with increasing frequency in a dose-related manner and
with repeat injections. Two injection site reactions included a seroma over the shoulder and swelling
lasting > 30 days. Dogs dosed at 36 mg/kg had a significant (P=0.0088) increase in BUN (all means
remained within the normal range) compared to the controls. One dog dosed at 60 mg/kg exhibited
a glomerulopathy on histopathology, and 1 dog in this same group had minimal peliosis hepatis.
At an exaggerated dose of 180 mg/kg (22.5X) in dogs, CONVENIA caused some injection site
irritation, vocalization, and edema. Edema resolved within 8-24 hours.
Cats
CONVENIA administered to healthy 4-month-old cats at doses of 12 mg/kg (1.5X), 36 mg/kg (4.5X),
and 60 mg/kg (7.5X) every 7 days by dorsoscapular subcutaneous injections was well-tolerated
for a total of 5 doses. Vomiting and diarrhea were observed in cats, with the incidence of vomiting
and the incidence and duration of diarrhea increasing in a dose-related manner. The mean albumin
values for all the CONVENIA-treated cats were significantly lower (P ≤ 0.05) than the control values
(all means remained within the normal range) for all time periods. The mean alkaline phosphatase
values in the 60 mg/kg group were significantly higher (P ≤ 0.0291) than the control values for all time
periods. Injection-site irritation and transient edema occurred with increasing frequency in a doserelated manner and with repeat injections. One cat in the 12 mg/kg group had a mild renal tubular and
interstitial fibrosis, and 1 cat in the 12 mg/kg group had mild glomerulosclerosis on histopathology.
At an exaggerated dose of 180 mg/kg (22.5X), CONVENIA was associated with injection site irritation,
vocalization, and edema. Edema resolved within 8-24 hours. On day 10, cats had lower mean white
blood cell counts compared to the controls. One cat had a small amount of bilirubinuria on day 10.
STORAGE INFORMATION:
Store the powder and the reconstituted product in the original carton, refrigerated at 2° to 8° C
(36° to 46° F). Use the entire contents of the vial within 56 days of reconstitution. PROTECT FROM
LIGHT. After each use it is important to return the unused portion back to the refrigerator in the
original carton. As with other cephalosporins, the color of the solution may vary from clear to
amber at reconstitution and may darken over time. If stored as recommended, solution color does
not adversely affect potency.
HOW SUPPLIED:
CONVENIA is available as a 10 mL multi-use vial containing 800 milligrams of cefovecin as
a lyophilized cake.
REFERENCES:
1
Pillai SK, Moellering RC, Eliopoulos GM. Antimicrobial combinations. In: Lorian V, ed.
Antibiotics in laboratory medicine. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins,
2005;365-440.
2
Fish DN, Choi MK, Jung R. Synergic activity of cephalosporins plus fluoroquinolones against
Pseudomonas aeruginosa with resistance to one or both drugs. J Antimicrob Chemother
2002;50:1045-1049.
3
Mayer I, Nagy E. Investigation of the synergic effects of aminoglycoside-fluoroquinolone and
third-generation cephalosporin combinations against clinical isolates of Pseudomonas spp. J
Antimicrob Chemother 1999;43:651-657.
4
Birchard SJ, Sherding RG. Saunders manual of small animal practice. 2nd ed. Philadelphia:
PA: WB Saunders Co, 2000;166.
NADA# 141-285, Approved by FDA
Distributed by:
Div. of Pfizer Inc
New York, NY 10017
Revised June 2011
11892301