Cephacare flavour 50 mg tablets for cats and 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:

50 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 50 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
50 mg cefalexin as cefalexin monohydrate.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Beige, round biconvex tablets.
The tablets should not be divided.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
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.
In cats:
Treatment of infections of the respiratory 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, toother 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 ANIMALSUse 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In the case of an allergic reaction, treatment should be withdrawn.
Health Products Regulatory Authority
12 March 2019
CRN008XSM
Page 2 of 4
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, anti