Equip WNV (previously Duvaxyn WNV)

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-04-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
10-04-2017
Public Assessment Report Public Assessment Report (PAR)
19-02-2014

Active ingredient:

инактивиран вирус на Западен Нил, щам VM-2

Available from:

Zoetis Belgium SA

ATC code:

QI05AA10

INN (International Name):

vaccine to aid in prevention of West Nile virus

Therapeutic group:

Коне

Therapeutic area:

Имунологични средства за еднокопитни животни

Therapeutic indications:

За активна имунизация на коне на възраст шест месеца и повече срещу болест на Западно-Нил-вирус чрез намаляване на броя на виремичните коне.

Product summary:

Revision: 13

Authorization status:

упълномощен

Authorization date:

2008-11-21

Patient Information leaflet

                                15
B. ЛИСТОВКА
16
ЛИСТОВКА ЗА:
EQUIP WNV ИНЖЕКЦИОННА ЕМУЛСИЯ ЗА КОНЕ
1.
ИМЕ
И ПОСТОЯНEН
АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА
ЗА УПОТРЕБА
И
НА ПРОИЗВОДИТЕЛЯ,
АКО ТЕ
СА РАЗЛИЧНИ
Притежател на лиценза за употреба и
производител, отговорен за
освобождаване на партидата:
Zoetis Belgium
SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
БЕЛГИЯ
2.
НАИМЕНОВАНИЕ
НА ВЕТЕРИНАРНОМЕД ИЦИНСКИЯ
ПРОДУКТ
Equip WNV инжекционна емулсия за коне
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА
СУБСТАНЦЯ И ЕКСЦИПИЕНТИТЕ
Всяка доза от 1 ml съдържа:
Активна субстанция:
Инактивиран вирус на западнонилската
треска, щам VM-2
ОЕ* 1.0–2.2
* Относителна ефикасност определена
чрез
_in vitro_
метод, сравнен с референтна ваксина,
ефикасна
при коне.
Аджувант:
SP oil
4.0% – 5.5% (v/v).
4.
ТЕРАПЕВТИЧНИ
ПОКАЗАНИЯ
За активна имунизация на коне,
навършили 6 месеца или по-големи, срещу
вируса на
западнонилската треска (WNV), за
намаляване на броя на конете с виремия
след заразяване с WNV
щам 1 или 2 и за намаляване на
продължителността и тежестта на
клиничните признаци срещу WNV
щам 2.
Начало на имунитета:
3 седмици след началния курс на
ваксинация.
Продължителност на имунитета: 12
месеца след началния курс на
ваксинация за WNV щам 1. За
WNV щам 2 продълж
                                
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Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ
I
КРАТКА ХАРАКТЕРИСТИКА
НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ
НА ВЕТЕРИНАРНОМЕД ИЦИНСКИЯ
ПРОДУКТ
Equip WNV инжекционна емулсия за коне
2.
КАЧЕСТВЕН
И КОЛИЧЕСТВЕН
СЪСТАВ
Всяка доза от 1 ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
Инактивиран вирус на западнонилска
треска, щам VM-2
ОЕ* 1.0- 2.2
*Относителна ефикасност определена
чрез
_in vitro_
метод, сравнен с референтна ваксина,
която
показва ефикасност при коне.
АДЖУВАНТ:
SP oil
4.0% – 5.5% (v/v)
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА
ФОРМА
Инжекционна емулсия.
4.
КЛИНИЧНИ
ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Коне.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
За активна имунизация на коне,
навършили 6 месеца или по-големи срещу
вируса на
западнонилската треска (WNV), за
намаляване на броя на конете с виремия
след заразяване с WNV
щам 1 или 2 и за намаляване на
продължителността и тежестта на
клиничните признаци срещу WNV
щам 2.
Начало на имунитета:
3 седмици след началния курс на
ваксинация.
Продължителност на имунитета: 12
месеца след началния курс на
ваксинация за WNV щам 1. За
WNV щам 2 продължителността на
имунитета не е определена.
4.3
ПРОТИВОПО
                                
                                Read the complete document

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Active ingredient инактивиран вирус на Западен Нил, щам VM-2

инактивиран вирус на Западен Нил, щам VM-2

ATC code QI05AA10

QI05AA10

Marketed by Zoetis Belgium SA

Zoetis Belgium SA

INN (International Name) vaccine to aid in prevention of West Nile virus

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Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 10-04-2017
Summary of Product characteristics Summary of Product characteristics Spanish 10-04-2017
Public Assessment Report Public Assessment Report Spanish 19-02-2014
Patient Information leaflet Patient Information leaflet Czech 10-04-2017
Summary of Product characteristics Summary of Product characteristics Czech 10-04-2017
Public Assessment Report Public Assessment Report Czech 19-02-2014
Patient Information leaflet Patient Information leaflet Danish 10-04-2017
Summary of Product characteristics Summary of Product characteristics Danish 10-04-2017
Public Assessment Report Public Assessment Report Danish 19-02-2014
Patient Information leaflet Patient Information leaflet German 10-04-2017
Summary of Product characteristics Summary of Product characteristics German 10-04-2017
Public Assessment Report Public Assessment Report German 19-02-2014
Patient Information leaflet Patient Information leaflet Estonian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Estonian 10-04-2017
Public Assessment Report Public Assessment Report Estonian 19-02-2014
Patient Information leaflet Patient Information leaflet Greek 10-04-2017
Summary of Product characteristics Summary of Product characteristics Greek 10-04-2017
Public Assessment Report Public Assessment Report Greek 19-02-2014
Patient Information leaflet Patient Information leaflet English 10-04-2017
Summary of Product characteristics Summary of Product characteristics English 10-04-2017
Public Assessment Report Public Assessment Report English 19-02-2014
Patient Information leaflet Patient Information leaflet French 10-04-2017
Summary of Product characteristics Summary of Product characteristics French 10-04-2017
Public Assessment Report Public Assessment Report French 19-02-2014
Patient Information leaflet Patient Information leaflet Italian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Italian 10-04-2017
Public Assessment Report Public Assessment Report Italian 19-02-2014
Patient Information leaflet Patient Information leaflet Latvian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Latvian 10-04-2017
Public Assessment Report Public Assessment Report Latvian 19-02-2014
Patient Information leaflet Patient Information leaflet Lithuanian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-04-2017
Public Assessment Report Public Assessment Report Lithuanian 19-02-2014
Patient Information leaflet Patient Information leaflet Hungarian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Hungarian 10-04-2017
Public Assessment Report Public Assessment Report Hungarian 19-02-2014
Patient Information leaflet Patient Information leaflet Maltese 10-04-2017
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Public Assessment Report Public Assessment Report Maltese 19-02-2014
Patient Information leaflet Patient Information leaflet Dutch 10-04-2017
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Public Assessment Report Public Assessment Report Dutch 19-02-2014
Patient Information leaflet Patient Information leaflet Polish 10-04-2017
Summary of Product characteristics Summary of Product characteristics Polish 10-04-2017
Public Assessment Report Public Assessment Report Polish 19-02-2014
Patient Information leaflet Patient Information leaflet Portuguese 10-04-2017
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Public Assessment Report Public Assessment Report Portuguese 19-02-2014
Patient Information leaflet Patient Information leaflet Romanian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Romanian 10-04-2017
Public Assessment Report Public Assessment Report Romanian 19-02-2014
Patient Information leaflet Patient Information leaflet Slovak 10-04-2017
Summary of Product characteristics Summary of Product characteristics Slovak 10-04-2017
Public Assessment Report Public Assessment Report Slovak 19-02-2014
Patient Information leaflet Patient Information leaflet Slovenian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Slovenian 10-04-2017
Public Assessment Report Public Assessment Report Slovenian 19-02-2014
Patient Information leaflet Patient Information leaflet Finnish 10-04-2017
Summary of Product characteristics Summary of Product characteristics Finnish 10-04-2017
Public Assessment Report Public Assessment Report Finnish 19-02-2014
Patient Information leaflet Patient Information leaflet Swedish 10-04-2017
Summary of Product characteristics Summary of Product characteristics Swedish 10-04-2017
Public Assessment Report Public Assessment Report Swedish 19-02-2014
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Patient Information leaflet Patient Information leaflet Croatian 10-04-2017
Summary of Product characteristics Summary of Product characteristics Croatian 10-04-2017
Public Assessment Report Public Assessment Report Croatian 19-02-2014

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Equip WNV (previously Duvaxyn WNV)