ITRAFUNGOL 10 MG/ML ORAL SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-02-2016
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Active ingredient:
ITRACONAZOLE
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QJ02AC02
INN (International Name):
ITRACONAZOLE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Feline
Therapeutic area:
Itraconazole
Therapeutic indications:
Antifungal
Authorization status:
Authorised
Authorization date:
2012-07-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Itrafungol 10 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
ACTIVE SUBSTANCES
MG/ML
Intraconazole
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
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 22/02/2016_
_CRN 7023169_
_page number: 1_
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,
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