Clavaseptin 750 mg palatable tablets for dogs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Amoxicillin trihydrate; Clavulanic acid

Commercializzato da:

Vetoquinol Ireland Limited

Codice ATC:

QJ01CR02

INN (Nome Internazionale):

Amoxicillin trihydrate; Clavulanic acid

Forma farmaceutica:

Tablet

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

amoxicillin and enzyme inhibitor

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2022-04-08

Scheda tecnica

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