Clavubactin 500/125 mg tablet
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
amoxicillin trihydrate 500 mg, clavulanic acid 125 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® 500/125 MG tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
_quantity _
Amoxicillin
(as amoxicillin trihydrate)
500 mg
Clavulanic acid
(as potassium clavulanate)
125 mg
EXCIPIENT(S):
Saccharin sodium
7.00 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellowish-white to light yellow oblong-formed tablet with round edges and embossement 625 on one
side.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in 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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