CLAVASEPTIN 250 MG PALATABLE TABLETS FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID

Available from:

Vetoquinol UK Limited

ATC code:

QJ01CR02

INN (International Name):

AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID

Dosage:

250 Milligram

Pharmaceutical form:

Tablets

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Amoxicillin and enzyme inhibitor

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2005-10-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 250 mg palatable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Tablet.
Beige scored tablet that can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in
combination with clavulanic acid i.e. _Pasteurella _spp, _Streptococcus _spp and _Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or other substances of the -lactam group or to any of
the excipients.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
Do not administer to horses and ruminating animals.
Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria.
Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each tablet contains:
Active substances:
Amoxicillin (as amoxicillin trihydrate)
200
mg
Clavulanic acid (as potassium salt)
50
mg
Excipients
Brown iron oxide (E172)
0.475 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/05/2016_
_CRN 7023487_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In addition to section 4.3 contraindications:
In animals with impaired liver and kidney function, the use of the product should be subject to a risk/benefit evaluation
by the veterinary surgeon and the posology evaluated care