Noroclav 50 mg Tablets for Dogs and Cats

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Amoxicillin trihydrate; potassium clavulanate

Disponible desde:

Norbrook Laboratories (Ireland) Limited

Código ATC:

QJ01CR02

Designación común internacional (DCI):

Amoxicillin trihydrate; potassium clavulanate

Dosis:

50 mg/tablet

formulario farmacéutico:

Tablet

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

amoxicillin and enzyme inhibitor

Estado de Autorización:

Authorised

Fecha de autorización:

2004-05-28

Ficha técnica

Health Products Regulatory Authority
22 August 2019
CRN008SHV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 50 mg Tablets for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Active Ingredients:
Amoxicillin (as amoxicillin trihydrate) 40 mg
Clavulanic acid (as Potassium clavulanate) 10 mg
Excipients:
Carmoisine Lake (E122) 0.245 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Round pink tablet with a score line and 50 embossed on opposing faces.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of the following infections caused by β-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 testing
when initiating the treatment. The treatment should only
proceed if sensitivity is proven to the combination.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin 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 the kidneys
accompanied by anuria and oliguria.
Do not use where resistance to this combination is known to occur.Do
not administer to horses and ruminating animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
22 August 2019
CRN008SHV
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
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 hepati