Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
Zoetis Ireland Limited
QJ01CR02
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
50
Tablets
POM
Canine, Feline
Amoxicillin and enzyme inhibitor
Antibacterial
Authorised
2015-01-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT SYNULOX Palatable Tablets 50 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet. Speckled pink flat circular tablets with bevelled edges. The tablet has a break line on one face and “SYNULOX” engraved on the other. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Clinically Synulox 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 (eg gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis. 4.3 CONTRAINDICATIONS Synulox Palatable Tablets should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in their use in any other very small herbivores. Synulox is not indicated for cases involving _Pseudomonas _spp. Do not use in animals with known hypersensitivity to the active ingredients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each tablet contains: Active ingredients Amoxicillin (as trihydrate) 40.0 mg Clavulanic acid (as Potassium clavulanate) 10.0 mg For a full list of excipients see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/01/2015_ _CRN 7019910_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. 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, Read the complete document