Nazione: Regno Unito
Lingua: inglese
Fonte: VMD (Veterinary Medicines Directorate)
Ketoconazole
Le Vet Beheer B.V.
QJ02AB02
Ketoconazole
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimycotic
Authorized
2014-11-04
Revised: May 2023 AN: 00059/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fungiconazol 200 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Ketoconazole 200 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, Leggi il documento completo