Itrafungol 10 mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Itraconazole

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QJ02AC02

INN (International Name):

Itraconazole

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats

Therapeutic area:

itraconazole

Therapeutic indications:

Antifungal

Authorization status:

Authorised

Authorization date:

2012-07-20

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2018
CRN000YH3
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Itrafungol 10 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/ML
Itraconazole
10
EXCIPIENTS:
Caramel (E150)
0.2
Propylene glycol (E1520)
103.6
Sorbitol 70% Non-crystallising Solution
245.1
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Yellow to slightly amber, clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cat.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of dermatophytosis caused by _Microsporum canis. _
4.3 CONTRAINDICATIONS
Do not administer to cats with hypersensitivity to itraconazole or one
of the other
ingredients.
Do not administer to cats with impaired liver or kidney function.
For use in pregnant and lactating queens: see section 4.7
Health Products Regulatory Authority
03 May 2018
CRN000YH3
Page 2 of 8
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Some cases of feline dermatophytosis can be difficult to cure,
especially in catteries.
Cats treated with itraconazole can still infect other cats with _M.
canis_ as long as they
are not mycologically cured. It is therefore advised to minimise the
risk of
re-infection or spread of infection by keeping healthy animals
(including dogs as
they can also be infected by _M. canis_) separate from cats that are
being treated.
Cleaning and disinfection of the environment with appropriate
fungicidal products is
highly recommended – especially in case of group problems.
When clipping the hair of infected cats, the advice of the
veterinarian should be
sought first.
Clipping of the hair coat is considered useful because it removes
infected hairs,
stimulates new hair growth and hastens recovery. It is strongly
recommended that
clipping is performed by a veterinarian. In cases with limited
lesions, hair clipping can
be limited to the lesions only, whereas in cats with generalized
dermatophytosis it is
recommended to clip the entire hair coat. Care should be