CLAVUBACTIN 250/62.5 MG TABLETS FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.), CLAVULANIC ACID (EQUIVALENT TO POTASSIUM CLAVULANATE PH. EUR.)

Available from:

Le Vet Beheer B.V.

ATC code:

QJ01CR02

INN (International Name):

AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.), CLAVULANIC ACID (EQUIVALENT TO POTASSIUM CLAVULANATE PH. EUR.)

Dosage:

250/62.5

Pharmaceutical form:

Tablets

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Amoxicillin and enzyme inhibitor

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-11-08

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavubactin 250/62.5 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 four equal parts.
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.
-
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), Streptococci,_
Bacteroides_ spp. (including beta-lactamase producing
strains),_ Fusobacterium necrophorum_ and Pasteurellae.
Each tablet contains:
ACTIVE SUBSTANCES:
_quantity_
Amoxicillin
(as amoxicillin trihydrate)
250
mg
Clavulanic acid
(as potassium clavulanate)
62.5
mg
EXCIPIENT(S)
Quinoline Yellow E104
0.3
mg
Titanium dioxide E171
0.5
mg
For the full list of excipients, see section 6.1.
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