Nisamox 50 mg Tablets for Dogs and Cats

Summary of Product characteristics

                                Revised: November 2019
AN: 00148/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nisamox 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)
0.245mg
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

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_.
Revised: November 2019
AN: 00148/2019
Page 2 of 7
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.
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 regime
                                
                                Read the complete document