Kesium 40 mg / 10 mg Chewable tablets for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

Ceva Santé Animale

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

50 mg/tablet

Pharmaceutical form:

Chewable 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:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
15 April 2021
CRN00C942
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Kesium 40 mg / 10 mg Chewable tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Amoxicillin (as amoxicillin trihydrate) 40.00 mg
Clavulanic acid (as potassium clavulanate) 10.00 mg
EXCIPIENT (S):
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable tablet
Oblong scored beige tablet.The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following infections caused by β lactamase
producing strains of bacteria sensitive to amoxicillin in
combination with clavulanic acid and where clinical experience and/or
sensitivity testing indicates the product as the drug of
choice:
-Skin infections (including superficial and deep pyodermas) associated
with _Staphylococcus_ spp.
-Urinary tract infections associated with _Staphylococcus_ spp.,
_Streptococcus _spp._, Escherichia coli_ and _Proteus mirabilis_.
-Respiratory tract infections associated with _Staphylococcus _spp._,
Streptococcus _spp. and _Pasteurella _spp.
-Digestive tract infections associated with _Escherichia coli_.
-Infections of the oral cavity (mucous membrane) associated with
_Pasteurella _spp._, Streptococcus_spp. and _Escherichia coli._
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or
other susbstances of the β-lactam group or to any excipients.
Do not use in animals with serious dysfunction of the kidneys
accompanied by anuria and oliguria.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and
chinchillas. Do not use in horses and ruminating animals.
Do not use where resistance to this combination is known to occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Officia