Clavaseptin 750 mg palatable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate; Clavulanic acid

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin trihydrate; Clavulanic acid

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:

2022-04-08

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAME
COUNTRIES
Clavaseptin 750 mg palatable tablets for dogs
Bulgaria, Cyprus, Greece, Czech
Republic, Hungary, Ireland, Latvia,
Lithuania, Norway, Poland, Romania,
Slovakia, Slovenia, UK
Clavaseptin P 750 mg tablets for dogs
France, Luxembourg
Clavaseptin 750 mg, tablets for dogs
Austria, Belgium, Estonia, Germany,
Italy, Netherlands, Portugal, Spain
Clavaseptin 600mg/150mg tablets for dogs
Denmark, Finland, Sweden
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substances:
Amoxicillin (as amoxicillin
trihydrate)……………….……………..………. ... 600 mg
Clavulanic acid (as potassium clavulanate,
diluted)………………………...... 150 mg
Excipients
Iron oxide, brown
(E172)………………………………….…..…….………….1.43
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Oblong, off -white to brownish speckled, scored tablets of about 24
mm. Tablet can be divided into
four 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 known 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