Exzolt
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
12-01-2022
Charakterystyka produktu
(SPC)
12-01-2022
Sprawozdanie z oceny publicznego
(PAR)
20-10-2017
Składnik aktywny:
fluralaner
Dostępny od:
Intervet International B.V.
Kod ATC:
QP53BE02
INN (International Nazwa):
fluralaner
Grupa terapeutyczna:
Chicken
Dziedzina terapeutyczna:
Ectoparaciticides, insecticides and repellents
Wskazania:
Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.
Podsumowanie produktu:
Revision: 3
Status autoryzacji:
Authorised
Data autoryzacji:
2017-08-18
Ulotka dla pacjenta
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET (50-ML PRESENTATION):
EXZOLT 10 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions SA
Rue de Lyons
27460 Igoville
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Exzolt 10 mg/ml solution for use in drinking water for chickens
fluralaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
ACTIVE SUBSTANCE:
Fluralaner
10 mg.
Solution for use in drinking water.
Light yellow to dark yellow solution.
4.
INDICATION(S)
Treatment of poultry red mite (
_Dermanyssus gallinae_
) infestation in pullets, breeders and layer hens.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
None known.
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.
7.
TARGET SPECIES
18
Chickens (pullets, breeders and layer hens).
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For use in drinking water.
The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05
ml of solution) administered
twice, 7 days apart. The complete course of treatment must be
administered for a full therapeutic
effect. If another course of treatment is indicated, the interval
between two courses of treatment should
be at least 3 months.
9.
ADVICE ON CORRECT ADMINISTRATION
Determine the duration of time (between 4 and 24 hours) over which to
administer the medicated
water on the treatment day. This period of time must be long enough to
allow all the birds to receive
the required dose. Estimate how much water birds will consume during
treatment based on the
previous day’s water consumption. The product should be added to a
volume of water
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Exzolt 10 mg/ml solution for use in drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
10 mg fluralaner
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Light yellow to dark yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (pullets, breeders and layer hens).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of poultry red mite (
_Dermanyssus gallinae_
) infestation in pullets, breeders and layer hens.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The following practices should be avoided because they increase the
risk of development of resistance
and could ultimately result in ineffective therapy:
-
too frequent and repeated use of acaricides from the same class, over
an extended period of time,
-
underdosing, which may be due to underestimation of body weight,
misadministration of the
product, or lack of calibration of the volume measuring device.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Strict biosecurity measures at house and farm level should be
implemented to prevent re-infestation of
treated houses. To ensure long term control of the mite populations in
a treated house, it is essential to
treat any other infested poultry in houses in proximity to the treated
one.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
The veterinary medical product may be slightly irritating to skin
and/or eyes.
Avoid contact with skin, eyes and mucous membranes.
Do not eat, drink or smoke while handling the product.
Wash hands and contacted skin with soap and water after use of the
product.
In case of eye contact, immediately rinse thoroughly with water.
3
If the product is spilled, remove any affected clothes.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE D
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