Itrafungol 10 mg/ml Oral Solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Itraconazole

Tilgængelig fra:

Virbac S.A.

ATC-kode:

QJ02AC02

INN (International Name):

Itraconazole

Dosering:

10 milligram(s)/millilitre

Lægemiddelform:

Oral solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

itraconazole

Autorisation status:

Authorised

Autorisation dato:

2012-07-20

Produktets egenskaber

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Itrafungol 10 mg/ml Oral Solution
Itrafungol vet 10 mg/ml Oral Solution (DK, FI, NO, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE
:
Itraconazole
10 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION
OF
EXCIPIENTS
AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL
FOR
PROPER
ADMINISTRATION
OF
THE
VETERINARY MEDICINAL PRODUCT
Caramel (E150)
0.2 mg
Propylene glycol (E1520)
103.6 mg
Sorbitol 70% Non-crystallising Solution
245.1 mg
Hydroxypropyl-b-cyclodextrin
Concentrated hydrochloric acid
Sodium hydroxide
Sodium saccharin
Cherry flavour
Purified water
Yellow to slightly amber, clear solution.
3.
CLINICAL INFORMATION
3.1 TARGET SPECIES
Cats.
3.2 INDICATIONS FOR USE, FOR EACH TARGET SPECIES
Treatment of dermatophytosis caused by
_Microsporum canis_
.
3.3 CONTRAINDICATIONS
Do not use in cats with hypersensitivity to itraconazole or one of the
other ingredients.
Do not use in cats with impaired liver or kidney function.
For use in pregnant and lactating queens: see section 3.7
3.4 SPECIAL WARNINGS
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 lesi