Clavucill 200 mg/50 mg, Tablets for Dogs

Summary of Product characteristics

                                Revised: June 2015
AN. 01644/2014 & AN: 01641/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavucill 200 mg/50 mg, Tablets for Dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE INGREDIENTS:
Amoxicillin (as amoxicillin trihydrate)
200.0 mg
Clavulanic acid (as potassium clavulanate)50.0 mg
EXCIPIENT(S):
Contains Erythrosine E127
0.25 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet:
Pale pink, bi-convex divisible tablet, scored on one 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
Clinically, amoxicillin has been shown to be effective in treating a
wide range of
diseases
of
dogs
including:
skin
disease
(including
deep
and
superficial
pyodermas);
soft
tissue
infections
(abscesses
and
anal
sacculitis);
dental
infections (e.g. gingivitis); urinary tract infection; respiratory
disease (involving
upper and lower respiratory tract); enteritis.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substances..
This product should not be given rabbits, guinea pigs, hamsters or
gerbils.
Caution is advised in their use in any other very small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: June 2015
AN. 01644/2014 & AN: 01641/2014
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
This product is not indicated for cases involving _Pseudomonas spp._
Use of the product deviating from the instructions given in the SPC
may
increase
the
prevalence
of
bacteria
resistant
to
penicillins
and
may
decrease
the
effectiveness
of
treatment
with
other
antimicrobials
or
classes of antimicrobials due to the potential for cross-resistance
ii)
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Penicillins
and
cephalosporins
may
cause
hypersensitivity
(allergy)
following injection, inhala
                                
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