Noroclav 250 mg Tablets for Dogs

Summary of Product characteristics

                                Revised: August 2019
AN: 01306/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 250 mg Tablets for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
ACTIVE INGREDIENTS:
Amoxicillin (as amoxicillin trihydrate) 200 mg
Clavulanic acid (as Potassium clavulanate) 50.0 mg
EXCIPIENTS:
Carmoisine Lake (E122) 1.225 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Round pink tablet with a score line and 250 embossed on opposing
faces.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
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 infection 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.
Revised: August 2019
AN: 01306/2018
Page 2 of 5
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
be carefully
evaluated.
Use of the product should be based on susceptibility testing a
                                
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