Exzolt

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
12-01-2022
Public Assessment Report Public Assessment Report (PAR)
20-10-2017

Active ingredient:

fluralaner

Available from:

Intervet International B.V.

ATC code:

QP53BE02

INN (International Name):

fluralaner

Therapeutic group:

Piletina

Therapeutic area:

Ektoparaciticidi, insekticidi i repelenti

Therapeutic indications:

Liječenje infekcije crvenog buba (Dermanyssus gallinae) peradi u uzgajivačima, uzgajivačima i slojevitim kokošima.

Product summary:

Revision: 3

Authorization status:

odobren

Authorization date:

2017-08-18

Patient Information leaflet

                                16
B. UPUTA O VMP
17
UPUTA O VMP (ZA 50 ML PAKIRANJA):
EXZOLT 10 MG/ML OTOPINA ZA PRIMJENU U VODI ZA PIĆE ZA KOKOŠI
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I
NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
SERIJE U PROMET, AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nizozemska
Proizvođač odgovoran za puštanje serije u promet:
Intervet Productions SA
Rue de Lyons
27460 Igoville
Francuska
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Exzolt 10 mg/ml otopina za primjenu u vodi za piće za kokoši
fluralaner
3.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
SASTOJAKA
Jedan ml sadrži:
DJELATNA TVAR:
Fluralaner
10 mg
Otopina za primjenu u vodi za piće.
Svijetložuta do tamnožuta otopina.
4.
INDIKACIJE
Liječenje infestacije crvenom tekuti (
_Dermanyssus gallinae_
) u pilenki, rasplodnih kokoši i nesilica.
5.
KONTRAINDIKACIJE
Nema.
6.
NUSPOJAVE
Nisu poznate.
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u
ovoj uputi o VMP ili mislite da
veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog
veterinara.
7.
CILJNE VRSTE ŽIVOTINJA
18
Kokoši (pilenke, rasplodne kokoši i nesilice).
8.
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
PRIMJENE
Za primjenu u vodi za piće.
Doza iznosi 0,5 mg fluralanera po kilogramu tjelesne mase (što
odgovara 0,05 ml otopine) u dvije
primjene u razmaku od 7 dana. Za potpuni terapijski učinak potrebno
je primijeniti cijeli ciklus
tretiranja. Ukoliko je indiciran i drugi ciklus tretiranja, interval
između dva ciklusa mora biti najmanje
3 mjeseca.
9.
SAVJETI ZA ISPRAVNU PRIMJENU
Utvrdite vremensko razdoblje (između 4 i 24 sata) tijekom kojeg ćete
kokošima davati vodu s
proizvodom na dan tretiranja. To razdoblje mora biti dovoljno dugo da
bi kokoši primile potrebnu
dozu. Procijenite koliko će vode kokoši popiti tijekom tretiranja na
temelju potrošnje prethodnog dana.
Proizvod se dodaje u količinu vod
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Exzolt 10 mg/ml otopina za primjenu u vodi za piće za kokoši
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaki ml sadrži:
DJELATNA TVAR:
10 mg fluralanera
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za primjenu u vodi za piće.
Svijetložuta do tamnožuta otopina.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Kokoši (pilenke, rasplodne kokoši i nesilice).
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Liječenje infestacije crvenom tekuti (
_Dermanyssus gallinae_
) u pilenki, rasplodnih kokoši i nesilica.
4.3
KONTRAINDIKACIJE
Nema.
4.4
POSEBNA UPOZORENJA ZA SVAKU OD CILJNIH VRSTA ŽIVOTINJA
Potrebno je izbjegavati sljedeće prakse jer one povećavaju rizik od
razvoja otpornosti i u konačnici
mogu rezultirati neučinkovitom terapijom:
-
prečesta i opetovana upotreba akaricida iste klase tijekom duljeg
vremenskog razdoblja,
-
davanje premalih doza, do kojeg može doći pogrešnom procjenom
tjelesne mase, pogrešnom
primjenom proizvoda ili nedostatkom kalibracije uređaja za mjerenje
količine.
4.5
POSEBNE MJERE OPREZA PRILIKOM PRIMJENE
Posebne mjere opreza prilikom primjene na životinjama
Da se spriječi reinfestacija tretiranih kokošinjaca, potrebno je
provoditi stroge biosigurnosne mjere na
razini kokošinjca i farme. Da se osigura dugoročna kontrola
populacija crvene tekuti u tretiranom
kokošinjcu, ključno je tretirati i sve druge infestirane kokošinjce
u blizini tretiranog.
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje
veterinarsko-medicinski proizvod na
životinjama
Veterinarsko-medicinski proizvod može biti blago nadražujući za
kožu i/ili oči.
Izbjegavajte dodir s kožom, očima i sluznicama.
Nemojte jesti, piti ni pušiti dok rukujete proizvodom.
Nakon primjene proizvoda ruke i kožu koja je bila u dodiru s
proizvodom operite sapunom i vodom.
Ako proizvod dođe u dodir s očima, odmah ih temeljito isperite
vodom.
3
Ako prolijete proizvod, s
                                
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Active ingredient fluralaner

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ATC code QP53BE02

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Marketed by Intervet International B.V.

Intervet International B.V.

INN (International Name) fluralaner

fluralaner

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Summary of Product characteristics Summary of Product characteristics Bulgarian 12-01-2022
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