Patient leaflet - Fungitraxx
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR:
Fungitraxx 10 mg/ml oral solution for ornamental birds
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Fungitraxx 10 mg/ml oral solution for ornamental birds itraconazole
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3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Active substance:
Itraconazole 10 mg/ml
Description:
Yellow to slightly amber, clear solution.
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4. INDICATION(S)
Psittaciformes, Falconiformes, Accipitriformes, Strigiformes, and Anseriformes:
For the treatment of aspergillosis.
Psittaciformes (only):
Also for the treatment of candidiasis.
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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.
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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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Ornamental birds, particularly:
Psittaciformes (specifically cockatoos and true parrots: parakeets; budgerigars)
Falconiformes (falcons)
Accipitriformes (hawks)
Strigiformes (owls)
Anseriformes (specifically swans)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administration route:
Oral use.
Amounts to be administered:
Aspergillosis: 5 to 10 mg (0.5 ml to 1 ml) itraconazole per kg bodyweight per day for 8 weeks.
For the treatment of African Grey Parrots (see section “Special warnings”) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day. If clinical signs show that the product is not well tolerated, then the treatment should be stopped.
In cases where, 8 weeks after the start of treatment, clinical signs are still present, or endoscopy indicates a fungal presence remains, the whole 8 weeks course of treatment should be repeated (using the same dosage regimen).
Candidiasis (Psittaciformes only):
10 mg (1 ml) itraconazole per kg bodyweight per day for 14 days.
For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section “Special warnings”).
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9. ADVICE ON CORRECT ADMINISTRATION
Do not use the medicine if you notice visible signs of deterioration.
To ensure the correct dose, and to avoid underdosing and overdosing, the bodyweight(s) of the bird(s) to be treated should be determined as accurately as possible. Your veterinarian will decide the correct dose for your bird(s).
The best method of administration of the oral solution is directly into the bird’s mouth. However, if direct oral administration is not feasible (for example, for raptors) the medicinal product can be administered with the bird’s food. (For example, for raptors a ‘spiked’ chick is generally used.) If the product has to be administered with the bird’s food, it should then be offered immediately to the bird(s), and discarded within 1 hour if it has not been consumed by then.
The 1 ml oral syringe has graduations for 0.05 ml solution (= 0.5 mg itraconazole).
The 5 ml oral syringe has graduations for 0.2 ml solution (= 2 mg itraconazole).
Remove the screw cap on the bottle. Using the oral syringe provided, place the syringe nozzle into the opening of the bottle and withdraw the necessary volume. Replace the screw cap after use.
Slowly and gently administer the oral solution into the mouth of the bird, allowing the bird to swallow it.
After dosing, the syringe should be washed with hot water and dried.
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not store above 25 °C.
Do not refrigerate or freeze.
Keep the bottle in the outer carton in order to protect from light.
Keep the bottle tightly closed.
Do not use this veterinary medicine after the expiry date which is stated on the label and carton.
Shelf life after first opening the bottle: 28 days.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
None.
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 related to this medicine, such as vomiting, loss of appetite 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 is recommended. An appropriate rate of air renewal in the environment of the treated birds is also important.
Frequent and repeated use of antifungals from the same class may increase the risk of development of resistance to that class of antifungals.
The prevalence of such acquired resistance may vary geographically and over time for specific species, and therefore local information on antifungal/azole resistance is desirable, particularly when treating severe infections.
Special precautions to be taken by the person administering the veterinary medicinal product to animals : Wash hands and exposed skin after use.
In case of accidental contact with the eyes, rinse thoroughly with water.
In case of accidental ingestion, rinse the mouth with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Some fungal infections of birds can be zoonotic diseases and infect humans. Because of the risk of transmission of aspergillosis to people, protective personal equipment consisting of latex gloves and a mask should therefore be worn when handling infected birds or when cleaning the syringe. If suspected lesions (such as the occurrence of cutaneous nodules or erythematous papules, respiratory symptoms such as coughing and wheezing) occur in humans, consult a physician.
Lay :
Do not use in birds in lay and within 4 weeks before the startof the laying period.
Laboratory studies in pregnant rats administered high dosages (40 and 160 mg/kg bodyweight daily for 10 days) have shown evidence of dose-related harmful effects to the pregnant rat and to the embryo/foetus.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this veterinary medicinal product when used in the target species with any other veterinary medicinal product. Co-administration of this product with other veterinary medicinal products should therefore be avoided. The information in the paragraph below is a summary of the known interactions between itraconazole and other medicinal products in humans, and in animals other than birds.
In humans it is known that itraconazole can inhibit the metabolism of medicinal products that are substrates for cytochrome 3A isoenzymes, for example, chloramphenicol, ivermectin or methylprednisolone. Although the relevance of this information for the target species (ornamental birds) is unknown, it is wise to avoid the use of such substances together with this product because an increase and/or a prolongation of their pharmacological effects, including side effects, may occur.
The concomitant use of the antibiotic erythromycin can result in an increased plasma concentration of itraconazole in the blood of the bird, which may result in increased adverse effects.
Laboratory animal studies have shown that when itraconazole is used together with amphotericin B it may be antagonistic against Aspergillus spp. or Candida spp.; the clinical importance of these findings is unclear.
Overdose (symptoms, emergency procedures, antidotes) :
No information on overdose is currently available in the target species. (See section “Adverse reactions”.)
Major incompatibilities :
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicine is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION