Negara: Portugal
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
cefalexin monohydrate 750 mg
Laboratories Sogeval
QJ01DB01
Tablet
Cefalexin
Dogs
2011-01-04
Revised: May 2012 AN: 00601/2011 Page - 1 - of 6 SUMMARY OF PRODUCT CHACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UK, AT, IE, PL, CZ, BE, HU, GK, LUX, NL, PT Therios 750 mg palatable tablets for dogs IT, ES, FI Therios 750 mg flavoured tablets for dogs DE Therios 750 mg aromatisierte Tabletten für Hunde NO Therios 750 mg, tyggetablett til hund. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Cefalexin (as cefalexin monohydrate)...........................750 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round scored beige palatable tablet The tablet can be divided into equal halves and quarters 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 pyoderma) caused by organisms sensitive to cefalexin. For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by organisms sensitive to cefalexin. 4.3 CONTRAINDICATIONS Do not use in animals which are known to be hypersensitive to penicillins. Do not use in case of severe renal failure Do not use in rabbits, guinea pigs, hamsters and gerbils. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: May 2012 AN: 00601/2011 Page - 2 - of 6 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation may occur when renal function is impaired. In case of known renal insufficiency the dose should be Baca dokumen lengkapnya