Cephacare Flavour 1000 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:

1000 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:

2017-03-01

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2022
CRN00CFM5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare Flavour 1000 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Cefalexin (as cefalexin monohydrate) 1000 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Brown speckled oblong tablet, with one side flat and other side
spherical with break mark on both sides.
The tablets can be divided into halves.
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.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
other cephalosporins, to other substances of the β-lactam
group or to any of the excipients.
Do not use in known cases of resistance to cephalosporins or
penicillins.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance has been shown between cephalosporins and
penicillins. Use of cefalexin should be carefully considered when
susceptibility testing has shown resistance to penicillins because its
effectiveness may be reduced.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal product should be based on
identification and susceptibility testing of the target pathogen(s)
isolated from the animal. If this is not possible, therapy should be
based on epidemiological information and knowledge of
susceptibility of the target pathogens at local / regional level.
Use of the product should be in accordance with official, national and
regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection
(lower AMEG category) should be used for first line
treatment where susceptibility testing s