Cylanic 500 mg + 125 mg tablets for dogs

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Amoxicillin trihydrate; Potassium clavulanate

Dostupné s:

LIVISTO Int'l, S.L.

ATC kód:

QJ01CR02

INN (Mezinárodní Name):

Amoxicillin trihydrate; Potassium clavulanate

Dávkování:

500/125 mg/tablet

Léková forma:

Tablet

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

amoxicillin and enzyme inhibitor

Stav Autorizace:

Authorised

Datum autorizace:

2021-05-28

Charakteristika produktu

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
CYLANIC 500 mg + 125 mg tablets for dogs.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Amoxicillin (as amoxicillin trihydrate) 500 mg
Clavulanic acid (as potassium clavulanate) 125 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.
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 instructions given in the SPC
may increase the prevalence
of bacteria resistant to
amoxicillin/clavulanic
acid and may