Exzolt

Country: European Union

Language: Bulgarian

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:

Пиле

Therapeutic area:

Ектопаратициди, инсектициди и репеленти

Therapeutic indications:

Лечение на заразяване с червена чума по домашните птици (Dermanyssus gallinae) при ясли, развъдчици и кокошки носачки.

Product summary:

Revision: 3

Authorization status:

упълномощен

Authorization date:

2017-08-18

Patient Information leaflet

                                16
B. ЛИСТОВКА
17
ЛИСТОВКА (50 ML ОПАКОВКА):
EXZOLT 10 MG/ML РАЗТВОР ЗА ПРИЛАГАНЕ ВЪВ ВОДА
ЗА ПИЕНЕ ЗА ПИЛЕТА
1.
ИМЕ И ПОСТОЯНEН АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА ЗА УПОТРЕБА
И НА ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
Притежател на лиценза за употреба:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Производител, отговорен за
освобождаване на партидата:
Intervet Productions SA
Rue de Lyons
27460 Igoville
France
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Exzolt 10 mg/ml разтвор за прилагане във вода
за пиене за пилета
fluralaner
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА СУБСТАНЦИЯ И
ЕКСЦИПИЕНТИТЕ
Един ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
Fluralaner 10 mg
Разтвор за прилагане във вода за
пиене.
Светложълт до тъмножълт разтвор.
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Третиране на ярки, родителски стада и
кокошки-носачки срещу опаразитяване с
кокошинки
(
_Dermanyssus gallinae_
).
5.
ПРОТИВОПОКАЗАНИЯ
Няма.
6.
НЕБЛАГОПРИЯТНИ РЕАКЦИИ
Не са известни.
Ако забележите някакви
неблагоприятни реакции, включително и
такива, които не са описани в
тази листовка или мислите, че
ветеринарномедицинския продукт не
работи, моля да уведомите
Вашия ветеринарен лекар.
7.
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
18
Пилета (ярки, родителск
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Exzolt 10 mg/ml разтвор за прилагане във вода
за пиене за пилета
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
10 mg fluralaner
ЕКСЦИПИЕНТИ:
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Разтвор за прилагане във вода за
пиене.
Светложълт до тъмножълт разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Пилета (ярки, родителски стада и
кокошки-носачки).
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
Третиране на ярки, родителски стада и
кокошки-носачки срещу опаразитяване с
кокошинки
(
_Dermanyssus gallinae_
).
4.3
ПРОТИВОПОКАЗАНИЯ
Няма.
4.4 СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ ЗА ВСЕКИ
ВИД ЖИВОТНИ, ЗА КОИТО Е ПРЕДНАЗНАЧЕН
ВМП
Да се избягват следните практики,
защото те повишават риска от развитие
на резистентност и
може да доведат до неефективно
лечение:
-
твърде често и повтарящо се прилагане
на акарициди от същия клас за удължен
период от
време;
-
недостатъчно дозиране, което може да
се дължи на неправилна оценка на
телесната маса,
неправилно прилагане на продукта
                                
                                Read the complete document

Similar products

Active ingredient fluralaner

fluralaner

ATC code QP53BE02

QP53BE02

Marketed by Intervet International B.V.

Intervet International B.V.

INN (International Name) fluralaner

fluralaner

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Patient Information leaflet Patient Information leaflet Spanish 12-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 12-01-2022
Public Assessment Report Public Assessment Report Spanish 20-10-2017
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Summary of Product characteristics Summary of Product characteristics Czech 12-01-2022
Public Assessment Report Public Assessment Report Czech 20-10-2017
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Public Assessment Report Public Assessment Report Danish 20-10-2017
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Public Assessment Report Public Assessment Report German 20-10-2017
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Public Assessment Report Public Assessment Report Estonian 20-10-2017
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Public Assessment Report Public Assessment Report Greek 20-10-2017
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Public Assessment Report Public Assessment Report English 20-10-2017
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