Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Itraconazole
Avimedical B.V.
QJ02AC02
itraconazole
Avian
Antimycotics for systemic use, Triazole derivatives, itraconazole
For the treatment of aspergillosis and candidiasis in companion birds,
Revision: 2
Authorised
2014-03-12
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET FOR: FUNGITRAXX 10 MG/ML ORAL SOLUTION FOR ORNAMENTAL BIRDS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Avimedical B.V. Abbinkdijk 1 7255 LX Hengelo (Gld) THE NETHERLANDS Manufacturer responsible for batch release: Floris Veterinaire Produkten B.V. Kempenlandstraat 33 5262 GK Vught THE NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Fungitraxx 10 mg/ml oral solution for ornamental birds itraconazole 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: Itraconazole 10 mg/ml DESCRIPTION: Yellow to slightly amber, clear solution. 4. INDICATION(S) Psittaciformes, Falconiformes, Accipitriformes, Strigiformes, and Anseriformes: For the treatment of aspergillosis. Psittaciformes (only): Also for the treatment of candidiasis. 5. CONTRAINDICATIONS Do not use in birds intended for human consumption. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 17 6. ADVERSE REACTIONS Itraconazole generally has a narrow margin of safety in birds. Vomiting, loss of appetite and loss of weight have commonly been observed in treated birds, however, these adverse reactions are usually mild and dose related. If vomiting, loss of appetite or loss of weight occurs, then in the first instance it is advisable to lower the dose (see section “Special warnings”) or treatment with the veterinary medicine should be discontinued. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fungitraxx 10 mg/ml oral solution for ornamental birds 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Itraconazole 10 mg. For the 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 Ornamental birds, particularly: Psittaciformes (specifically cockatoos and true parrots: parakeets; budgerigars) Falconiformes (falcons) Accipitriformes (hawks) Strigiformes (owls) Anseriformes (specifically swans) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Psittaciformes, Falconiformes, Accipitriformes, Strigiformes, and Anseriformes: For the treatment of aspergillosis. Psittaciformes (only): Also for the treatment of candidiasis. 4.3 CONTRAINDICATIONS Do not use in birds intended for human consumption. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Itraconazole is generally not well tolerated by African Grey Parrots and therefore the product should only be used with care in this species and if no alternative treatment is available and with the lowest recommended dose for the whole of the recommended treatment period. Other Psittaciformes also appear less tolerant to itraconazole than other birds. Therefore if suspected adverse reactions such as emesis, anorexia or weight loss occur, the dose should be lowered, or treatment with the medicinal product should be discontinued. Where there is more than one bird in the home/cage, all infected and treated birds should be separated from other birds. In accordance with good animal husbandry, the cleaning and disinfection of the infected birds’ environment with an appropriate antifungal product should be recommended. An appropriate rate of air renewal in the environment of the tre Aqra d-dokument sħiħ