Kesium 200 mg / 50 mg Chewable Tablets for Dogs

Summary of Product characteristics

                                Revised: June 2023
AN: 03887/2022 & 03891/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kesium 200 mg / 50 mg Chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Amoxicillin (as amoxicillin trihydrate)
200.00 mg
Clavulanic acid (as potassium clavulanate)
50.00 mg
EXCIPIENT (S):
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable tablet
Clover-shaped scored beige tablet. The tablet can be divided into four
equal parts
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES:
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:
For the treatment of the following infections caused by

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, Escherichia coli._
Revised: June 2023
AN: 03887/2022 & 03891/2022
Page 2 of 8
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or
other substances
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

                                
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