Fungiconazol

10 x 10 pc

Tablet

Active substance

Ketoconazole : 200 mg

ATC code

QJ02AB02 Ketoconazole

QJ02AB Imidazole derivatives

QJ02A Antimycotics for systemic use

QJ02 Antimycotics for systemic use

QJ Antiinfectives for systemic use

Species

Dogs.

Indications

Treatment of dermatomycoses due to the following dermatophytes:

- Microsporum canis,

- Microsporum gypseum,

- Trichophyton mentagrophytes.

Dose to be administered and administration route

Oral use.

10 mg of ketoconazole per kg body weight daily, by oral administration. This corresponds to 1 tablet per 20 kg body weight daily.

It is recommended to sample the animal once a month during treatment and to stop antifungal administration after two negative cultures. When mycological follow up is not possible, treatment should be continued for an adequate period of time to ensure mycological cure. If lesions persist after 8 weeks of treatment, medication should be re-evaluated by the responsible veterinarian.

To be administered preferably together with food, in order to maximise absorption.

Tablets can be divided into halves or quarters to ensure accurate dosing. Put the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

Halves: With the tip of the thumbs, exert a slight vertical pressure on both sides of the tablet to break it into halves.

Quarters: With the tip of a thumb, exert a slight vertical pressure on the middle of the tablet to break it into quarters.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Adverse reactions

Dogs:

Rare

(1 to 10 animals / 10,000 animals treated):

Neurological signs^a (e.g. Ataxia, Tremor)

Apathy^a, Anorexia^a

Hepatic toxicosis^a

Vomiting^a, Diarrhoea^a

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Endocrine system disorder (anti-androgenic effects^b,c, anti-glucocorticoid effects^b

^a May be observed at standard doses.

^bTransient. Ketoconazole inhibits the conversion of cholesterol to steroid hormones such as testosterone and cortisol in a dose dependent and time-dependent manner.

^c See also section Special precautions for safe use in the target species for effects in male breeding dogs.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.