Land: Storbritannia
Språk: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Amoxicillin, Clavulanic Acid
Zoetis UK Limited
QJ01CR02
Amoxicillin, Clavulanic Acid
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Antimicrobial
Authorized
1990-08-20
Revised: March 2022 AN: 01525/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SYNULOX PALATABLE TABLETS 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredients:_ mg per tablet Amoxicillin 40.0 (as Amoxicillin Trihydrate) 45.9 Clavulanic acid 10.0 (as Potassium Clavulanate) 11.9 For the full list of all other excipients see section 6.1. 3. PHARMACEUTICAL FORM Tablet. (Circular pink scored tablets). 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product has been shown to be effective in treating a wide range of diseases of cats and dogs 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. 4.3 CONTRAINDICATIONS The product should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in their use in any other very small herbivores. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: March 2022 AN: 01525/2021 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross- Les hele dokumentet