Noroclav 50 mg Tablets for Dogs and Cats

Summary of Product characteristics

                                Revised: August 2019
AN: 01306/2018
Page 1 of 6
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 βlactamase 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.
Revised: August 2019
AN: 01306/2018
Page 2 of 6
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.
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 hepatic and renal failure, the dosing regimen should
b
                                
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