Clavusan 50 mg + 12.5 mg tablets for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate; potassium clavulanate

Available from:

Alfasan Nederland B.V

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin trihydrate; potassium clavulanate

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

amoxicillin and enzyme inhibitor

Authorization date:

2023-04-14

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavusan 50 mg + 12.5 mg tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Amoxicillin (as amoxicillin trihydrate)
50 mg
Clavulanic acid (as potassium clavulanate)
12.5 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Crospovidone
Povidone
Sodium starch glycolate type A
Cellulose microcrystalline
Silica colloidal
hydrated
Magnesium stearate
Saccharin sodium
Vanilla flavour
White to slightly yellow, round and convex tablet with a cross-shaped
break line on one side.
The tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For treatment of infections caused by bacteria susceptible to
amoxicillin and clavulanic acid including:
skin disease (including deep and superficial pyodermas); soft tissue
infections (abscesses and anal
sacculitis); dental infections (e.g. gingivitis); urinary tract
infections; respiratory disease (involving
upper and lower respiratory tract); enteritis.
3.3
CONTRAINDICATIONS
Do not use in rabbits, guinea pigs, hamsters, gerbils or chinchillas.
Do not use in known cases of hypersensitivity to the active
substances, to other antimicrobials of the
β-lactam group or to any of the excipients.
Do not use in animals with serious dysfunction of the kidneys
accompanied by anuria and oliguria.
Do not use in ruminants and horses.
3.4
SPECIAL WARNINGS
None.
2
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Use
of
the
product
should
be
based
on
identification
and
susceptibility
testing
of
the
target
pathogen(s). If this is not possible, therapy should be based on
epidemiological information and
knowledge of susceptibility of the target pathogens at local/regional
level. Use of the product should
be in accordance with official, national and regional antimicrobial
policies.
An antibiotic with a lower risk of antimicrobial resistance sele