Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Vetoquinol Ireland Limited
QJ01CR02
Amoxicillin; Clavulanic acid
250 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
amoxicillin and enzyme inhibitor
Authorised
2005-10-21
Health Products Regulatory Authority 04 December 2019 CRN0091Q7 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clavaseptin 250 mg palatable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substances: Amoxicillin (as amoxicillin trihydrate) 200 mg Clavulanic acid (as potassium salt) 50 mg Excipients Brown iron oxide (E172) 0.475 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Beige scored tablet that can be divided into two equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. _Pasteurella _spp, _Streptococcus_ spp and _Escherichia coli_. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to penicillins or other substances of the β-lactam group or to any of the excipients. Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not administer to horses and ruminating animals. Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria. Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In animals with impaired liver and kidney function, the use of the product should be subject to a risk/benefit evaluation by the veterinary surgeon and the posology evaluated carefully. Caution is advised in the use in small herbivores other than those in 4.3. Use of the product should be based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other β-lactam antibiotics, due to the Health Pr Olvassa el a teljes dokumentumot