Clavubactin 250/62.5 mg Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin, Clavulanic Acid

Available from:

Le Vet B.V.

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin, Clavulanic Acid

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2010-10-11

Summary of Product characteristics

Revised: February 2017
AN: 01471/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NL: Clavoral 250/62.5 mg tabletten voor honden
CZ: Clavubactin 250/62.5 mg tablety pro psi
ES: Clavubactin 250/62.5 mg comprimidos para perros
FR: Clavubactin 250/62.5 mg comprimés pour chiens
HU: Clavubactin 250/62.5 mg tabletta kutyák számára
IE: Clavubactin 250/62.5 mg tablets for dogs
IS: Clavubactin vet. 250/62.5 mg töflur fyrir hunda
IT: Clavubactin 250/62.5 mg compresse per cani
PL: Clavubactin vet. 250/62.5 mg tabletki dla psów
SK: Clavubactin 250/62.5 mg tablety pre psov
UK: Clavubactin 250/62.5 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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:
Revised: February 2017
AN: 01471/2016
Page 2 of 7
-
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-
lactama