Clavaseptin 250 mg Tablets for Dogs

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

AMOXICILLIN; CLAVULANIC ACID

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

AMOXICILLIN; CLAVULANIC ACID

Units in package:

100 Tablets

Manufactured by:

Vetoquinol

Summary of Product characteristics

INDICATIONS
IN
DOGS:
treatment
or
adjunctive
treatment
of
periodontal infections caused by bacteria susceptible
to amoxicillin in combination with clavulanic acid i.e.
_Pasteurella_ spp, _Streptococcus_ spp and _Escherichia coli_.
DOSAGE
FOR
EACH
SPECIES,
ROUTE
AND
METHOD OF ADMINISTRATION
10 mg amoxicillin and 2.5 mg clavulanic acid per kg
body weight twice a day by the oral route in dogs,
i.e. 1 tablet per 20 kg body weight every 12 h,
according to the following table:
In severe infections, the dose may be doubled to
20 mg amoxicillin and 5 mg clavulanic acid/kg body
weight twice daily.
DURATION OF TREATMENT:
- 7 days for the treatment of periodontal infections in
dogs.
To ensure the correct dosage, body weight should be
determined
as
accurately
as
possible
to
avoid
under-dosing.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to
penicillins or other substances of the β-lactam group.
Do not administer to gerbils, guinea pigs, hamsters,
rabbits and chinchillas. Do not administer to horses
and ruminating animals. Do not use in animals with
serious dysfunction of the kidneys accompanied by
anuria or oliguria. Do not use in cases of known
resistance to the combination of amoxicillin and
clavulanic acid.
NUMBER OF TABLETS TWICE DAILY
BODYWEIGHT (KG)
[ 8.1 - 10 ]
½
1
1 ½
2
[ 10.1 - 20 ]
[ 20.1 - 30 ]
[ 30.1 - 40 ]
Other organisms:
sensitive: MIC
≤
8/4 µg/ml, resistant: MIC
≥
32/16 µg/ml
IN DOG periodontal infections in Europe (isolates of
the year 2002 from France, Germany and Belgium)
amoxicillin/clavulanic acid combination in a ratio 2/1
showed the following data on sensitivity:
_Streptococcus_ spp.:
MIC
90
: 0.4/0.2 µg/ml,
_Pasteurellaceae_:
MIC
90
: 0.4/0.2 µg/ml,
_Escherichia coli_:
MIC
90
: 5.3/2.6 µg/ml,
_Enterobacteriaceae:_
MIC
90
: 22.6/11.3 µg/ml,
except for Enterobacter spp.
_Pseudomonadaceae:_
MIC
90
: 147.0/73.5 µg/ml,
_Enterobacter spp.:_
MIC
90
: 49.6/24.8 µg/ml
Resistance to β-lactam antibiotics is mainly mediated
by β-lactamases which hydrolyze antibiotics such a