Noroclav 50 mg Tablets for Dogs and Cats

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amoxicillin trihydrate; potassium clavulanate

Dostupno od:

Norbrook Laboratories (Ireland) Limited

ATC koda:

QJ01CR02

INN (International ime):

Amoxicillin trihydrate; potassium clavulanate

Doziranje:

50 mg/tablet

Farmaceutski oblik:

Tablet

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Područje terapije:

amoxicillin and enzyme inhibitor

Status autorizacije:

Authorised

Datum autorizacije:

2004-05-28

Svojstava lijeka

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