Noroclav 500 mg Palatable Tablets for Dogs

Summary of Product characteristics

                                Revised: October 2012
AN: 00697/2012
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 500 mg Palatable Tablets 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:
Carmoisine Lake (E122)
2.45mg
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: October 2012
AN: 00697/2012
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 failu
                                
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