Clavaseptin 750 mg Palatable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin, Clavulanic Acid

Available from:

Vetoquinol UK Ltd

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin, Clavulanic Acid

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2022-05-09

Summary of Product characteristics

Issued: May 2022
AN: 01361/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavaseptin 750 mg palatable tablets for dogs
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.
Issued: May 2022
AN: 01361/2020
Page 2 of 6
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 benefit/risk 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 pro