Clavaseptin 250 mg Palatable Tablets for Dogs

Summary of Product characteristics

                                Revised: February 2020
AN: 00191/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 250 mg Palatable tablets for dogs
Amoxicillin/Clavulanic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substances:
Amoxicillin (as amoxicillin
trihydrate)……………….……………..……….
200 mg
Clavulanic acid (as potassium
salt)……………………………………............. 50 mg
Excipients
Brown iron oxide
(E172)………………………………….…..…….………….0,475
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Beige scored tablet that can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to penicillins or other
substances of the β-lactam
group or to any of the excipients.
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.
Revised: February 2020
AN: 00191/2019
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In animals with impaired liver and kidney function, the use of the
product should be subject
to a risk/benefit evaluation by the veterinary surgeon and the
posology evaluated carefully.
Caution is advised in the use in small herbivores other than those in
4.3.
Use of the product should be based on susceptibility testing.
Use of the product deviating fr
                                
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