Fungiconazol 400 mg Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoconazole

Available from:

Le Vet Beheer B.V.

ATC code:

QJ02AB02

INN (International Name):

Ketoconazole

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimycotic

Authorization status:

Authorized

Authorization date:

2014-11-05

Summary of Product characteristics

Revised May 2023
AN: 00059/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fungiconazol 400 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Ketoconazole
400 mg
EXCIPIENTS: For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Brown spiked, round flavoured tablets, quadrisect.
The tablets can be divided into halves and quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of dermatomycoses due to the following dermatophytes:
-
_Microsporum canis,_
-
_Microsporum gypseum,_
-
_Trichophyton mentagrophytes._
4.3
CONTRAINDICATIONS
Do not administer to animals with liver failure.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Although rare, repeated use of ketoconazole may induce
cross-resistance to
other azoles.
Revised May 2023
AN: 00059/2023
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Treatment with ketoconazole suppresses testosterone concentrations and
increases progesterone concentrations and may affect breeding
effectiveness in
male dogs during and for some weeks after treatment.
Treatment of dermatophytosis should not be limited to treatment of the
infected
animal(s). It should also include disinfection of the environment,
since spores
can survive in the environment for long periods of time. Other
measures such
as frequent vacuuming, disinfection of grooming equipment and removal
of all
potentially contaminated material that cannot be disinfected will
minimize the
risk of re-infection or spread of infection.
Combination of systemic and topical treatment is recommended.
In case of long term treatment administration, liver function should
be closely
monitored. If clinical signs suggestive of liver dysfunction develop,
treatment
should be discontinued immediately. As the tablets are flavoured,