Cephacare flavour 500 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalexin monohydrate

Available from:

Ecuphar NV

ATC code:

QJ01DB01

INN (International Name):

Cefalexin monohydrate

Dosage:

500 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

cefalexin

Authorization status:

Authorised

Authorization date:

2008-12-19

Summary of Product characteristics

Health Products Regulatory Authority
12 March 2019
CRN008XSM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare flavour 500 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
500 mg cefalexin as cefalexin monohydrate.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Beige, flat tablets with a break mark on one side.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the respiratory tract, gastro-intestinal
tract, urogenital tract, the skin and localised infections in soft
tissue caused by bacteria sensitive to cefalexin.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance,
to other cephalosporins, to other substances of the
ß-lactam group or to any of the excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and take
into account official and local antimicrobial policies.
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 for cross resistance.
In the case of an allergic reaction, treatment should be withdrawn.
As with other antibiotics which are excreted mainly by the kidneys,
unnecessary accumulation may occur in the body when
renal function is impaired. In cases of known renal insufficiency the
dose should be reduced, antimicrobials known to be
nephrotoxic should not be administered concurrently and the product
should be used only according to a risk/benefit
assessment by the responsible veterinarian.
Health Products Regulatory Authority
12 March 2019
CRN008XSM
Page 2 of 4
SPECIAL PRECAUTIONS TO