Clavaseptin 500 mg palatable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin, Clavulanic acid

Available from:

Vetoquinol UK Limited

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin, Clavulanic acid

Dosage:

500 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

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 500 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)
400
mg
Clavulanic acid (as potassium salt)
100
mg
Excipients
Brown iron oxide (E172)
0.950 mg
For the full list of excipients, see section 6.1.
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