Twinox 200 mg/50 mg Tablets for Dogs

Summary of Product characteristics

                                Issued: June 2015
AN: 01329/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Twinox 200 mg/50 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Amoxicillin (as amoxicillin trihydrate) 200 mg
Clavulanic acid (as potassium clavulanate)
50 mg
EXCIPIENT
Erythrosine (E127)
0.25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale pink, rounded, one side scored, uncoated and divisible tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by micro-organisms sensitive to the
combination
amoxicillin/clavulanic acid, especially:
- dermatitis (superficial and deep pyoderma) caused by _Staphylococcus
_
_(pseud)intermedius_.
- urinary tract infections caused by _E. coli_ and _Staphylococcus_
spp.
- respiratory tract infections caused by _Streptococcus_ spp.
- enteritis caused by _E. coli_.
4.3
CONTRAINDICATIONS
- Do not use in animals with known hypersensitivity to penicillin or
other substances
of the beta-lactam group or to any of the excipients.
- Do not use in case of serious dysfunction of the kidneys accompanied
by anuria
and oliguria.
- Do not use in rabbits, guinea pigs, hamsters, chinchillas or
gerbils.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Issued: June 2015
AN: 01329/2013
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
-
Do not use in known cases of resistance to the combination
-
Official, national and regional antimicrobial policies with respect to
the use of
broad-spectrum antibiotics should be taken into account.
-
Do not use in known cases of bacteria sensitive to narrow spectrum
penicillins or
to amoxicillin as a single substance.
-
Due to likely variability (time geographical) in the occurrence of
resistance of
bacteria for the combination amoxicillin / clavulanic acid,
bacteriological sampling
and susceptibility testing are recomm
                                
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