Petalexin 300 mg Tablets for Dogs

Summary of Product characteristics

                                Unlimited renewal: October 2022
AN: 01535/2022
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
PETALEXIN 300 mg tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
- Active substance
Cefalexin
…………………………………………………..300 mg
(as Cefalexin Monohydrate)
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
Creamy oblong tablet with small brown spots marked with a score-line.
The tablets can be divided into halves.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial skin infections in dogs (including deep
and superficial
pyodermas) caused by organisms susceptible to Cefalexin.
For the treatment of urinary-tract infections in dogs (including
nephritis and cystitis)
caused by organisms susceptible to Cefalexin.
4.3 CONTRA-INDICATIONS
Do not use in animals known to be hypersensitive to penicillins and
cephalosporins.
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in known cases of hypersensitivity to the active substance,
to other
cephalosporins, to other substances of the β-lactam group or to any
of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Unlimited renewal: October 2022
AN: 01535/2022
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As with other antibiotics which are excreted mainly by the kidneys,
unnecessary
accumulation may occur in the body when renal function is impaired. In
case of
known renal insufficiency, the dose should be reduced and
antimicrobials known to
be nephrotoxic should not be administered concurrently.
This product should not be used to treat puppies of less than 1 kg of
bodyweight.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to Cefalexin and may decrease the
effectiveness of
treatment with penicillins due to the potential f
                                
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