Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate; potassium clavulanate
Alfasan Nederland B.V
QJ01CR02
Amoxicillin trihydrate; potassium clavulanate
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
amoxicillin and enzyme inhibitor
2023-04-14
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clavusan 500 mg + 125 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Amoxicillin (as amoxicillin trihydrate) 500 mg Clavulanic acid (as potassium clavulanate) 125 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Crospovidone Povidone Sodium starch glycolate type A Cellulose microcrystalline Silica colloidal hydrated Magnesium stearate Saccharin sodium Vanilla flavour White to slightly yellow, round and convex tablet with a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For treatment of infections caused by bacteria susceptible to amoxicillin and clavulanic acid including: skin disease (including deep and superficial pyodermas); soft tissue infections (abscesses and anal sacculitis); dental infections (e.g. gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis. 3.3 CONTRAINDICATIONS Do not use in rabbits, guinea pigs, hamsters, gerbils or chinchillas. Do not use in known cases of hypersensitivity to the active substances, to other antimicrobials of the β-lactam group or to any of the excipients. Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria. Do not use in ruminants and horses. 3.4 SPECIAL WARNINGS None. 2 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Use of the product should be based on identification and susceptibility testing of the target pathogen(s). 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 Đọc toàn bộ tài liệu