Nisamox 250 mg Tablets for Dogs

Summary of Product characteristics

                                Revised: November 2019
AN: 00148/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nisamox 250 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS:
Amoxicillin (as amoxicillin trihydrate)
200 mg
Clavulanic acid (as Potassium clavulanate)
50 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 scorelines 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

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 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.
Revised: November 2019
AN: 00148/2019
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with known cases of 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.
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 failure, the dosing regimen should
be
carefully evaluated.
Use of the product should be based on susc
                                
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