Synuclav Palatable Tablets 500 mg for Dogs

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

Ingredientes activos:

Amoxicillin, Clavulanic Acid

Disponible desde:

Norbrook Laboratories Limited

Código ATC:

QJ01CR02

Designación común internacional (DCI):

Amoxicillin, Clavulanic Acid

formulario farmacéutico:

Tablet

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Dogs

Área terapéutica:

Antimicrobial

Estado de Autorización:

Authorized

Fecha de autorización:

2006-07-18

Ficha técnica

Revised: September 2015
AN. 00687/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Synuclav Palatable Tablets 500 mg for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active Ingredients:
Amoxicillin (as amoxicillin trihydrate)
400 mg
Clavulanic acid (as potassium clavulanate)
100 mg
Colouring Agent:
Lake Carmoisine (E122)
2.45 mg
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Pink divisible circular tablet with score line on one face and
figure 500 embossed on
opposing face. The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of the following infections caused by beta-lactamase
producing strains of
bacteria sensitive to amoxicillin in combination with clavulanic acid:
-
Skin infections (including superficial and deep pyodermas) caused by
susceptible
Staphylococci.
-
Urinary tract infections caused by susceptible Staphylococci or
Escherichia coli.
-
Respiratory infections caused by susceptible Staphylococci.
-
Enteritis caused by susceptible Escherichia coli.
It is recommended to carry out suitable tests for sensitivity when
initiating the treatment.
The treatment should only proceed if sensitivity is proven to the
combination.
Revised: September 2015
AN. 00687/2015
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with known cases of hypersensitivity to
penicillins or other substances
of the beta-lactam group.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Do not use in animals with serious dysfunction of kidneys accompanied
by anuria or
oliguria.
Do not use where resistance to the combination is known to occur.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
amoxicillin/clavulanic acid.
In animals with hepatic and renal failure,