Clavubactin 50/12.5
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
amoxicillin trihydrate 50 mg, clavulanic acid 12.5 mg
Available from:
Le Vet B.V
ATC code:
QJ01CR01
Pharmaceutical form:
Tablet
Therapeutic group:
ampicillin and enzyme inhibitor
Therapeutic area:
Cats, Dogs
Authorization date:
2011-03-30
Summary of Product characteristics
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CLAVUBACTIN® 50/12.5 MG tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
_quantity _
Amoxicillin
(as amoxicillin trihydrate)
50 mg
Clavulanic acid
(as potassium clavulanate)
12.5 mg
EXCIPIENT(S):
Saccharin sodium
0.70 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellowish-white to light yellow oblong tablet with breakmark on both sides.
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.
-
Enteritis 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), Streptococci, _Bacteroides spp _
(including beta-lactamase producing strains), _Fusobacterium necrophorum _and Pasteurellae.
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