Fungitraxx
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
27-03-2019
Svojstava lijeka
(SPC)
27-03-2019
Izvješće o ocjeni javnog
(PAR)
29-04-2014
Aktivni sastojci:
Itraconazole
Dostupno od:
Avimedical B.V.
ATC koda:
QJ02AC02
INN (International ime):
itraconazole
Terapijska grupa:
Avian
Područje terapije:
Antimycotics for systemic use, Triazole derivatives, itraconazole
Terapijske indikacije:
For the treatment of aspergillosis and candidiasis in companion birds,
Proizvod sažetak:
Revision: 2
Status autorizacije:
Authorised
Datum autorizacije:
2014-03-12
Uputa o lijeku
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
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Svojstava lijeka
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
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