Clavaseptin 62.5 mg Palatable tablets for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin, Clavulanic acid

Available from:

Vetoquinol UK Limited

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin, Clavulanic acid

Dosage:

50, 12.5 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

amoxicillin and enzyme inhibitor

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-04-26

Summary of Product characteristics

Health Products Regulatory Authority
20 April 2018
CRN000TN3
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 62.5 mg Palatable tablets for dogs and cats
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 halves.
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 animals with known 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.
Health Products Regulatory Authority
20 April 2018
CRN000TN3
Page 2 of 7
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 risk/benefit evaluation by the veterinary surgeon and the
posology
evaluated carefully.
Caution is advised in the use in small herbivo