Itrafungol 10 mg/ml Oral Solution

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Itraconazole

Dostępny od:

Elanco Europe Ltd

Kod ATC:

QJ02AC02

INN (International Nazwa):

Itraconazole

Forma farmaceutyczna:

Oral solution

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats

Dziedzina terapeutyczna:

Antimycotic

Status autoryzacji:

Authorized

Data autoryzacji:

2002-12-13

Charakterystyka produktu

Revised: October 2020
AN: 00844/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Itrafungol 10 mg/ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MG/ML
ACTIVE SUBSTANCE(S): 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
4.4
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.
Revised: October 2020
AN: 00844/2020
Page 2 of 7
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