Clavubactin 50/12.5 mg Tablets for Cats and Dogs

Summary of Product characteristics

                                Revised: February 2016
AN: 01488/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK: Clavubactin 50/12.5 mg tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
_quantity_
Amoxicillin
(as amoxicillin trihydrate)
50
mg
Clavulanic acid
(as potassium clavulanate)
12.5 mg
EXCIPIENT(S):
Quinoline Yellow E104
0.06
mg
Titanium dioxide E171
0.10
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Yellowish-white to light yellow round tablet with a cross-shaped break
mark on one
side.
The tablets can be divided into 4 equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in cats and dogs caused by bacteria sensitive
to amoxicillin
in combination with clavulanic acid, particularly:
-
Skin infections (including superficial and deep pyodermas) associated
with
Staphylococci (including beta-lactamase producing strains) and
Streptococci.
-
Urinary tract infections associated with Staphylococci (including
beta-lactamase
producing strains), Streptococci, _Escherichia coli _(including
beta-lactamase
producing strains), _Fusobacterium necrophorum _and _Proteus spp_.
-
Respiratory tract infections associated with Staphylococci (including
beta-
lactamase producing strains), Streptococci and Pasteurellae.
-
Gastrointestinal tract infections associated with _Escherichia coli
_(including beta-
lactamase producing strains) and Proteus spp.
-
Infections of the oral cavity (mucous membrane) associated with
Clostridia,
Corynebacteria, Staphylococci (including beta-lactamase producing
strains),
Revised: February 2016
AN: 01488/2014
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Streptococci, _Bacteroides spp _(including beta-lactamase producing
strains),
_Fusobacterium necrophorum _and Pasteurellae.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin or
other substances of
the beta-lactam group or any of the exci
                                
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