TWINOX 200 MG/50 MG TABLETS FOR DOGS
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:
200/50
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine
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 200 mg/50 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Amoxicillin (as amoxicillin trihydrate)
200 mg
Clavulanic acid (as potassium clavulanate)
50 mg
EXCIPIENT
Erythrosine (E127)
0.25 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.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_.
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/08/2015_
_CRN 7021500_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
-
Do not use in known cases of resistance to the combination.
-
Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be
taken into account.
-
Do no
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