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 Ireland 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 area:

amoxicillin and enzyme inhibitor

Authorization status:

Authorised

Authorization date:

2005-10-21

Summary of Product characteristics

Health Products Regulatory Authority
04 December 2019
CRN0091Q7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 500 mg palatable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3 PHARMACEUTICAL FORM
Tablet.
Beige scored tablet that can be divided into two equal parts.
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 cases of hypersensitivity to penicillins or other
substances of the β-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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 carefully.
Caution is advised in the use in small herbivores other than those in
4.3.
Use of the product should be based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to
amoxicillin/clavulanic acid and may decrease the effectiveness of
treatment with other β-lactam antibiotics, due to the
Health P