Clavaseptin 62.5 mg Palatable Tablets for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Amoxicillin, Clavulanic Acid

Available from:

Vetoquinol UK Ltd

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin, Clavulanic Acid

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2013-04-17

Summary of Product characteristics

                                Revised: February 2020
AN: 00191/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 62.5 mg Palatable tablets for dogs and cats
Amoxicillin/Clavulanic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substances:
Amoxicillin (as amoxicillin
trihydrate)……………….……………..……… 50 mg
Clavulanic acid (as potassium
salt)…………………………..……………..12.5 mg
Excipients
Brown iron oxide
(E172)………………………………….…..…….……...
0.120 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 and cats
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_.
In cats: treatment of skin infections (including wounds and abscesses)
caused by
bacteria susceptible to amoxicillin in combination with clavulanic
acid i.e. _Pasteurella _
spp, _Staphylococcus _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.
Revised: February 2020
AN: 00191/2019
Page 2 of 7
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.
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 ri
                                
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