TWINOX 40 MG/10 MG TABLETS FOR DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-09-2015
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Active ingredient:
AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED : CELLULOSE, MICROCRYSTALLINE(1:1))
Available from:
Virbac S.A.
ATC code:
QJ01CR02
INN (International Name):
AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED : CELLULOSE, MICROCRYSTALLINE(1:1))
Dosage:
40/10
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Amoxicillin and enzyme inhibitor
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2015-07-17
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Twinox 40 mg/10 mg tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Amoxicillin (as amoxicillin trihydrate)
40 mg
Clavulanic acid (as potassium clavulanate) 10 mg
EXCIPIENTS
Erythrosine (E127)
0.05 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pale pink, rounded, one side scored, uncoated and divisible tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of infections caused by micro-organisms sensitive to the combination amoxicillin/clavulanic acid, especially:
- dermatitis (superficial and deep pyoderma) caused by _Staphylococcus (pseud)intermedius_.
- urinary tract infections caused by _E. coli _and _Staphylococcus _spp.
- respiratory tract infections caused by _Streptococcus _spp.
- enteritis caused by _E. coli_.
Cats:
Treatment of infections caused by micro-organisms sensitive to the combination amoxicillin/clavulanic acid, especially:
- dermatitis (superficial and deep pyoderma) caused by _Staphylococcus (pseud)intermedius_.
- urinary tract infections caused by _E. coli_
- respiratory tract infections caused by _Streptococcus _spp.
- enteritis caused by _E. coli_.
4.3 CONTRAINDICATIONS
- Do not use in animals with known hypersensitivity to penicillin or other substances of the
beta-lactam group or to any of the excipients.
- Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria.
- Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 1
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