Clavubactin 500/125 mg Tablets for Dogs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Amoxicillin, Clavulanic Acid

MAH:

Le Vet B.V.

ATC_code:

QJ01CR02

INN:

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

SPC

Revised: February 2017
AN: 01471/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavubactin 500/125 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
_quantity_
Amoxicillin
(as amoxicillin trihydrate)
500
mg
Clavulanic acid
(as potassium clavulanate)
125
mg
EXCIPIENT(S):
Quinoline Yellow E104
0.6
mg
Titanium dioxide E171
1.0
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
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),
Revised: February 2017
AN: 01471/2016
Page 2 of 7
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 excipients.
Do not use in serious dysf