Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Cefalexin
Animalcare Limited
QJ01DB01
Cefalexin
500 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
cefalexin
Antibacterial
Authorised
2008-12-19
Health Products Regulatory Authority 06 July 2018 CRN000YMD Page 1 of 6 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 b -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. Health Products Regulatory Authority 06 July 2018 CRN000YMD Page 2 of 6 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 In the case of an allergic reaction, treatment should be withdrawn.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. SPECIAL PRECAUTIONS TO B Read the complete document