Cylanic 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:

LIVISTO Int'l, S.L.

ATC code:

QJ01CR02

INN (International Name):

Amoxicillin trihydrate; Potassium clavulanate

Dosage:

50/12.5 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:

2021-05-28

Summary of Product characteristics

Health Products Regulatory Authority
28 May 2021
CRN009M31
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cylanic 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:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
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.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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.
4.3 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
The association amoxicillin/clavulanic acid should be reserved for the
treatment of clinical conditions which have responded
poorly to other classes of antimicrobials or narrow spectrum
penicillins. Whenever possible, the association
amoxicillin/clavulanic acid should only be used based on
susceptibility testing.
Use of the product deviating from the