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FAQs about
CONVENIA
What is CONVENIA?
What is CONVENIA?
The active component of CONVENIA is cefovecin, an injectable broad spectrum
third generation cephalosporin. It is presented as a lyophilised pellet that, after
reconstitution with 10ml of sterile water for injection, contains 80mg/ml cefovecin.
What are the indications for CONVENIA?
CONVENIA is indicated for use in dogs and cats for the treatment of serious infections
that are susceptible to ß-lactam antibiotics.
Dogs:
For the treatment of the skin and soft tissue infections including pyoderma,
wounds and abscesses associated with Staphylococcus intermedius, ß-haemolytic
Streptococci, Escherichia coli and/or Pasteurella multocida.
For the treatment of urinary tract infections associated with Escherichia coli and/or
Proteus spp.
Cats:
For the treatment of skin and soft tissue abscesses and wounds associated with
Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis,
ß-haemolytic Streptococci and/or Staphylococcus intermedius.
For the treatment of urinary tract infections associated with Escherichia coli.
What is the spectrum of activity of CONVENIA?
CONVENIA has an extended spectrum of bactericidal activity against Gram-positive
and Gram-negative aerobes and anaerobes, including many penicillinase-producing
strains. CONVENIA is not active against Pseudomonas spp., Bordetella spp.,
Enterococcus spp., or MRSA (methicillin resistant Staphylococcus aureus).
What is the dosage and
administration method of
CONVENIA?
A dose of CONVENIA is administered to dogs and
cats as a 0.1 mL/kg (8 mg/kg) subcutaneous
injection.
Animal body
weight (kg)
Dose volume
(mL)
2.5
0.25
5
0.5
10
1.0
20
2.0
40
4.0
60
6.0
How should CONVENIA be stored?
Before and after reconstitution, store CONVENIA refrigerated between 2 ºC and 8 ºC.
Reconstituted suspension can be stored for 28 days. CONVENIA should be stored
in its original box protected from light because of photodegradation, typical of the
cephalosporin class.
Why does reconstituted CONVENIA change its colour
during storage?
After mixing, CONVENIA will naturally colour amber over time. This change in colour
has no impact on CONVENIA’s safety or efficacy, provided that it is stored according to
label directions and used within 28 days of reconstitution. The colour change is a typical
characteristic of the cephalosporin class of compounds.
Can I use reconstituted CONVENIA after 28 days?
Some stability data for CONVENIA is available after 28 days, but the product does begin
to degrade and therefore efficacy can be adversely affected. It is not recommended to
use CONVENIA more than 28 days after reconstitution because there is the potential for
the drug to fall below specifications for potency after 28 days.
How is CONVENIA
different?
CONVENIA is different because its antimicrobial activity persists for up to 14 days after a
single injection.
What is the advantage of a single injection regimen?
A single injection of CONVENIA delivers a course of antibiotics equivalent to 2 weeks of
daily, oral antibiotic treatment in a single dose. This helps to maximize compliance by
providing an assured course of treatment and removes noncompliance as a contributor
to treatment failure. The pet owner is relieved of the burden of giving oral medication
at home.
What is the mechanism of action of CONVENIA?
CONVENIA is bactericidal and works by binding to penicillin binding proteins and
interfering with crosslinking of peptidoglycan in bacterial cell walls, causing bacteriolysis
and death.
What is the pharmacokinetic advantage of CONVENIA?
CONVENIA’s pharmacokinetics represent an advance in antibiotic therapy. CONVENIA
has a uniquely long elimination half-life in dogs and cats: it is highly (>96%) protein
bound, has a high affinity for plasma proteins and a relatively slow rate of excretion by
the kidneys.
How is it possible for CONVENIA to deliver a course
of antibiotic therapy in a single dose?
Administration of CONVENIA is the therapeutic equivalent to a continuous infusion of an
antibiotic. CONVENIA bound to the plasma protein creates a reservoir, gradually released
in small amounts over time as free, active drug. The long duration of CONVENIA in dogs
and cats is a natural property of the cefovecin molecule. CONVENIA is not a sustained
release formulation or adjuvanted to be long-lasting.
What are the pharmacokinetic characteristics of
CONVENIA?
• It is rapidly and completely adsorbed following subcutaneous administration and is
extensively distributed to target tissues.
• It has a very long terminal elimination half-life in both cats and dogs. Mean terminal
plasma elimination after subcutaneous injection of 8mg/kg in dogs and cats was
135.8 hours (SD ± 12.1) and 166.3 hours (SD ± 18.2) respectively.
• It is not highly metabolised and is eliminated mainly unchanged via the kidneys. A
second minor route of excretion is via the bile.
What happens if CONVENIA is left out of the
refrigerator, the box, or both?
CONVENIA should be stored in the refrigerator in the original box between uses. Limited
stability studies have been completed looking at potency of the product in case it is
accidentally left out at room temperature in a clinic environment. These studies suggest
that a few hours of accidental exposure to room temperature or ambient light should not
significantly affect potency.
What
cacy of of
Whatisisthe
theeffi
efficacy
CONVENIA?
CONVENIA?
Is CONVENIA as effective as antibiotics with oral dosing
Is CONVENIA as effective as antibiotics
regimens?
with oral dosing regimens?
AA single
is as
effective
as as
other
oraloral
cephalosporin
treatments
singleinjection
injectionofofCONVENIA
CONVENIA
is as
effective
other
cephalosporin
treatments
against
feline
and
canine
skin
and
soft
tissue
infections
(SSTI)
and
against
urinary
tract Tract
against feline and canine skin and soft tissue infections (SSTI) and against
Urinary
infections
(UTI).
Infections (UTI).
Field study of SSTI in cats: Treatment outcomes 1 *
100
60
98.1%
96.2%
98.1%
93.4%
40
20
0
14 days after final SC injection
CONVENIA 8 mg/kg
28 days after final SC Injection
Oral cephalosporin 22mg/kg, once daily
* The statistical significance of the results were only measured at 28 days.
Similarly, CONVENIA has demonstrated equivalent efficacy to a multi-day course of
amoxycillin/clavulanic acid in feline SSTI’s.
* The statistical significance of the results were only measured at 28 days.
CONVENIA
efficacy
Clinical success (% )
80
Field studies
studies of
of SSTI
SSTI in
in dogs:
dogs: Treatment
Treatment outcomes
outcomes 22 **
Field
100
100
Clinical
Clinicalsuccess
success(%)
(%)
80
80
60
60
93.1%
93.1%
91.2%
91.2%
93.2%
93.2%
94.7%
94.7%
40
40
20
20
0
0
14
14 days
days after
after final
final SC
SC Injection
Injection
CONVENIA
CONVENIA
efficacy
efficacy
CONVENIA
CONVENIA 8
8 mg/kg
mg/kg
28
28 days
days after
after final
final SC
SC injection
injection
Oral
Oral cephalosporin
cephalosporin 22mg/kg,
22mg/kg, BID
BID
3
UTIs
UTIs were
were cured
cured in
in 91.7%
91.7% of
of dogs
dogs injected
injected with
with CONVENIA
CONVENIA 3 **
91.7%
91.7%
65.3%
65.3%
0
0
10
10
20
20
30
30
40
40
50
50
60
60
70
70
80
80
90
90
100
100
Clinical success
success (%)
(%)
Clinical
CONVENIA 8
8 mg/kg
mg/kg
CONVENIA
Oral cephalosporin
cephalosporin 22mg/kg,
22mg/kg, BI
BID
D
Oral
For the
the treatment
treatment of
of canine
canine urinary
urinary tract infections,
infections, a
a single dose
dose of
of CONVENIA
CONVENIA
For
For the treatment
of canine
urinary tracttract
infections,
a singlesingle
dose of CONVENIA
3
3
demonstrated high
high efficacy
efficacy and
and safety.
safety.
demonstrated
3
demonstrated high efficacy and safety.
* The statistical significance of the results were only measured at 28 days.
** The
The statistical
statistical significance
significance of
of the
the results
results were
were only
only measured
measured at
at 28
28 days.
days.
What clinical trials support CONVENIA?
The efficacy of CONVENIA (cefovecin sodium) suspension for injection has been globally
established in 11 separate clinical trials involving over 700 dogs and over 400 cats
in Europe, Japan and the USA. Each of these trials was multicenter, randomized, and
double-blind.
How often can injections be repeated in the case of
recurrent infections (e.g. deep pyoderma)?
Factors to be considered in the determination of additional doses are the nature and
severity of the infection, the susceptibility of the pathogen, and the immune status of the
animal. Susceptibility of bacterial pathogens should be determined prior to treatment.
In dogs, CONVENIA may be administered on four consecutive occasions at 14 day
intervals, equivalent to an 8 week antibiotic course.
In cats, CONVENIA may be administered on two consecutive occasions, at 14 day
intervals, equivalent to a 4 week antibiotic course.
What is the safety profile
of CONVENIA?
What is the systemic safety of CONVENIA?
As with other ß-lactam antibiotics, CONVENIA has an excellent safety profile. In
veterinary patient clinical studies CONVENIA was administered to over 700 dogs and
over 400 cats without serious or significant adverse reaction related to CONVENIA
administration.
What is the safety margin of CONVENIA?
In safety studies CONVENIA was administered subcutaneously to healthy 4-month old
animals, at 1.5, 4.5, and 7.5 times the recommended dose, once a week (as opposed
to once every 2 weeks) for 4 consecutive weeks (total of 5 injections) with no significant
adverse reaction attributable to the product.
What are the most likely side effects to be seen after the
administration of CONVENIA?
Over 4 million doses of CONVENIA have been administered in the field to date and this
has confirmed the excellent tolerance profile of CONVENIA.
Side effects are thus rarely to be expected but when seen are typically those most
commonly associated with the cephalosporins and include anorexia, lethargy and
gastrointestinal signs (diarrhoea, vomiting). Neurological signs (ataxia, muscle tremors
and seizures) and injection site reactions have also uncommonly been reported.
If an animal develops a suspected hypersensitivity
reaction following a dose of CONVENIA, will it persist for
an extended period given the drugs extended systemic
clearance?
This has not been reported in the now large number of cats and dogs to which the
product has been administered. Interestingly, when signs of hypersensitivity have been
reported, these signs generally resolve following symptomatic treatment within 3 to 5 days.
Suspected adverse events should be reported to Pfizer Animal Health on 0800 650 277.
Does CONVENIA compete with other highly protein
bound drugs?
In vitro testing has demonstrated that the concentration of some highly bound drugs
will increase when they are co-incubated with cefovecin. The clinical significance of
these displacement interactions is not, however, known. During CONVENIA safety and
efficacy clinical studies, numerous concurrent treatments (including highly bound drugs
such as NSAID’S) were administrated to cats and dogs without reports of interactions.
It is thus not anticipated that clinicians should need to alter the therapeutic parameters
(dose administrated, treatment interval, route of administration) of CONVENIA should
it be administrated concurrently with other highly protein bound drugs, although it is
recommended that practitioners monitor dogs on concomitant medications for signs of
possible drug interactions.
Can CONVENIA be used in animals with
hypoproteinaemia??
The efficacy and safety of CONVENIA in hypoteinaemic animals has not been tested.
Theoretically, its use in these animals may result in proportionately more free drug
with excess, unbound drug expected to be more rapidly excreted by the kidney. It is
estimated, however, that for this to occur, the hypoproteinaemia would have to be so
severe as to be life threatening.
What is the local tolerability of CONVENIA?
Local tolerance is excellent with injection site reactions (swelling, tenderness) rarely
reported. In a 30 day laboratory safety study, a single dose of CONVENIA was administered
subcutaneously to healthy 7-month old animals at 22.5 times the recommended
dose (180 mg/kg) without serious or significant adverse reaction related to CONVENIA
administration.
Can CONVENIA be used in pregnant and lactating
animals?
As no studies have been performed in breeding animals with CONVENIA, it should not be
used in pregnant or lactating animals.
What is the youngest age I can use CONVENIA?
The safe use of CONVENIA in animals less than 8 weeks of age has not been established.
What breeds of dogs has CONVENIA been used in during
clinical trials?
In studies conducted to support registration, CONVENIA was administered to 393 dogs
representing 63 different pure breeds and 25 different mixed breeds. The most common
breeds were: Labrador Retriever, Hound, Golden Retriever, Beagle, Cocker Spaniel,
Rottweiler, Pitbull, Poodle, German Shepherd, Dachshund, Lhasa Apso, Shih Tzu, Miniature
Schnauzer, Boxer, Yorkshire Terrier, Shetland Sheepdog.
What are the Contraindications and Warnings for
CONVENIA?
CONTRAINDICATIONS: CONVENIA should not be used in: Cases of hypersensitivity to
cephalosporin or penicillin antibiotics. Small herbivores (including guinea pigs and rabbits).
WARNINGS: Caution should be exercised in patients that have previously shown
hypersensitivity reactions to cefovecin, other cephalosporins, penicillins or other drugs. If
an allergic reaction occurs, no further cefocevin should be administered and appropriate
therapy for ß-lactam hypersensitivity should be instituted.
Additionally, because it is highly protein bound, CONVENIA should be used with caution
when it is concomitantly used with other protein bound drugs. Such drugs include NSAIDs,
anti-convulsant, cardiac and behavioural medications.
Why
compliance
Why isiscompliance
important?
important?
How
prevalentisisnon-compliance
noncompliancewith
withantibiotic
antibiotic
How prevalent
regimens
regimens
in
Companion
Animal
medicine?
in companion animal medicine?
Compliance has
extensively
studied
in human
medicine,
but hasbut
so far
Compliance
hasbeen
been
extensively
studied
in human
medicine,
hasreceived
so far recieved
attention ininthe
eld. However,
behaviour
is the
keykey
factor
less attention
theveterinary
veterinaryfifield.
However,human
human
behaviour
is the
factor in both,
in both, situations.
Noncompliance
in veterinary
medicine
vary widely,
but
situations.
Noncompliance
data in data
veterinary
medicine
vary widely,
but consistently
consistently
that a substantial
percentage
of pet owners
not comply
with
indicate
thatindicate
a substantial
percentage
of pet owners
do not do
comply
with treatment
treatment
instructions.
Importantly,
studies
have
confi
rmed
that
vets
are
not
able
to
instructions. Importantly, studies have confirmed that vets are not able to predict
which
predict
which
owners
will
or
will
not
comply.
owners will or not comply.
Percentage of owners assessed as fully compliant
80
% owners
60
40
32% 10% 71%
44%
20
0
Barter L., et al. 4
MEMS †
†
Pill count
Grave K., et al.5
Self report
MEMS = Medication Event Monitoring System
†MEMS = Medication Event Monitoring System
CONVENIA
compliance
Has antibiotic
antibiotic noncompliance
to to
have
Has
noncompliancebeen
beendemonstrated
demonstrated
an
impact
on
cure
rates?
have an impact on cure rates?
Yes.
analysis,cure
curerates
rateswere
were
significantly
lower
in patients
Yes. In
In aa retrospective
retrospective analysis,
signifi
cantly lower
in patients
who who
took
took
less
than
80%
of
their
antibiotic
therapy
compared
with
those
who
took
less than 80% of their antibiotic therapy compared with those who took more than more
80% than
80%
of
medication
as
prescribed.
A
review
of
6
separate
compliance
studies
shows
that
of medication as prescribed. A review of 6 separate compliance studies shows that
treatment
success
is
far
greater
where
patients
are
compliant
rather
than
noncompliant.
treatment success is far greater where patients are compliant rather than noncompliant.
Studies by lead author
100
Clinical success (% )
80
60
40
94% 59%
95% 50%
82% 57%
100% 68%
88% 68%
89% 70%
20
0
Anastasio 6
Compliant
Venuta 7
MASCOT 8
Jordan9
Green10
Iiyama 11
Noncompliant
How does
does CONVENIA
CONVENIA help
help to
toimprove
improvecompliance?
compliance?
How
CONVENIA
compliance
A single
single injection
assures
that
thethe
petpet
receives
its antibiotic
treatment
injectionofofCONVENIA
CONVENIA
assures
that
receives
its antibiotic
treatment as
as
prescribed
and
eliminates
non-compliance
as
the
major
cause
of
treatment
prescribed and eliminates noncompliance as the major
of treatmentfailures
failures
and/or relapses
therapy.
and/or
relapsesininantibiotic
antibiotic
therapy.
Notes
Can I give CONVENIA IM or IV?
CONVENIA is only labelled for SC injection.
Other than slightly more rapid absorption after IM injection, the pharmacokinetic
response after SC and IM injection is comparable.
No adverse events were noted when a similar (but not identical) formulation was
administrated IV in a pharmacokinetic study.
References:
1. Data on file (Study: 1183C-60-00-237).
2. Data on file (Study: 1163C-60-00-468).
3. Data on file (Study: 1163C-60-00-469).
4. Barter L et al. Owner compliance with short term antimicrobial medication in dogs.
Aust Vet J 1996;74:277-80.
5. Grave K et al. Compliance with short-term oral antibacterial drug treatment in dogs.
J Small Anim Pract 1999;40:158-62.
6. Anastasio GD et al. Impact of Compliance and Side Effects on the Clinical Outcome of Patients
Treated With Oral Erythromycin. Pharmacotherapy 1994;14(2):229-34.
7. Venuta A. Azithromycin Compared with Clarithromycin for the Treatment of Streptococcal
Pharyngitis in Children. J Med Res 1998;26:152-8.
8. MASCOT study group. Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment
of childhood pneumonia: a multicentre double-blind trial. The Lancet 2002;360:835-41.
9. Jordan WC. Doxycycline vs. Tetracycline in the Treatment of Men with Gonorrhea: The Compliance
Factor. Sex Transm Dis 1981;8(Suppl. 2):105-9.
10. Green JL et al. Recurrence rate of streptococcal pharyngitis related to oral penicillin.
J Pediatr 1969;75(2):292-4.
11. Iiyama M et al. Juvenile Prescription Treatment Compliance. Pediatrics 2002;43(1).
The information contained in this document is consistent with the New Zealand Convenia Approved label.
Convenia® is a registered trademark of Pfizer Inc. Registered pursuant to the ACVM Act 1997, No
A10032 (P.A.R.) Class I. For use only under the authority or prescription of a veterinarian. Active
ingredient: cefovecin sodium. Pfizer Animal Health - A division of Pfizer New Zealand Ltd, Level 3,
Pfizer House, 14 Normanby Road, Mt Eden, Auckland, New Zealand. Tel: 0800 650 277, Fax: 0800 628 629.