SYNULOX PALATABLE TABLETS 50 MG
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-01-2015
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Active ingredient:
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
Available from:
Zoetis Ireland Limited
ATC code:
QJ01CR02
INN (International Name):
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
Dosage:
50
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Amoxicillin and enzyme inhibitor
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2015-01-09
Summary of Product characteristics
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,
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