国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Cefalexin
Forum Products Limited
QJ01DB01
Cefalexin
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimicrobial
Authorized
1999-06-11
Revised: March 2016 AN: 01390/2015 SUMMARY OF PRODUCTS CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephorum 250 mg film-coated tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE INGREDIENT: Cefalexin 250 mg as cefalexin monohydrate 263 mg EXCIPIENTS: Titanium dioxide (E171) 0.55 mg Excipient qsp 1 tablet of 355 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet Round, white to yellowish, biconvex tablet, scored on one side. ‘CX’ is imprinted above the scoreline, ‘250’ is imprinted below the scoreline. The tablets are not divisible. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of urinary tract infections in dogs caused by _Klebsiella pneumoniae_ and for the treatment of bacterial skin infections in dogs, when susceptible organisms are present. 4.3 CONTRA-INDICATIONS Do not use in cases of known 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 rabbits, gerbils, guinea pigs and hamsters. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE Page 1 of 7 Revised: March 2016 AN: 01390/2015 Page 2 of 7 Revised: March 2016 AN: 01390/2015 i. Special precautions for use in animals Use of the product should be based on susceptibility testing and take in to 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 potential cross-resistance. In case of an alle 阅读完整的文件