Ultifend ND IBD

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970
Public Assessment Report Public Assessment Report (PAR)
01-01-1970

Active ingredient:

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Available from:

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

ATC code:

QI01AD16

INN (International Name):

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Therapeutic group:

Embryonated chicken eggs; Chicken

Therapeutic area:

Имунологични за аве

Therapeutic indications:

For the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by Newcastle disease virus (NDV) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (IBDV); to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus (MDV).

Authorization status:

упълномощен

Authorization date:

2021-04-20

Patient Information leaflet

                                13
B. ЛИСТОВКА
14
ЛИСТОВКА:
ULTIFEND ND IBD КОНЦЕНТРАТ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОННА СУСПЕНЗИЯ 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 и
производител, отговорен за
освобождаване на партидата:
Cеva-Phylaxia Co. Ltd.
1107 Budapest, Szállás u 5.
Hungary
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Ultifend ND IBD концентрат и разтворител за
инжекционна суспензия за пилета
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА СУБСТАНЦИЯ И
ЕКСЦИПИЕНТИТЕ
Всяка доза (0.05 ml или 0.2 ml) съдържа:
АКТИВНА СУБСТАНЦИЯ:
Клетъчно асоцииран жив рекомбинантен
пуешки херпес вирус (rHVT/ND/IBD),
експресиращ фузион
протеин на вируса на болестта Нюкасъл
(NDV) и VP2 протеин на вируса на
инфекциозния бурзит:
мин. 4000, макс. 12000 PFU
*
*
Плакообразуващи единици
Концентрат: жълтеникаво кафяв
хомогенен концентрат.
Разтворител: бистър оранжев до червен
разтвор.
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
За активна имунизация на 18-дневни
ембрионирани яйца или еднодневни
пилета:
•
за намаляване на смъртността,
клиничните признаци и лезиите,
предизвикани от вируса на
болестта Нюкасъл по птиците (NDV) и за
намаляване отделянето на 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Ultifend ND IBD концентрат и разтворител за
инжекционна суспензия за пилета
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка доза (0.05 ml или 0.2 ml) съдържа:
АКТИВНА СУБСТАНЦИЯ:
Клетъчно асоцииран жив рекомбинантен
пуешки херпес вирус (rHVT/ND/IBD),
експресиращ фузион
протеин на вируса на болестта Нюкасъл
(NDV) и VP2 протеин на вируса на
инфекциозния бурзит:
мин. 4000, макс. 12000 PFU
*
*
Плакообразуващи единици
ЕКСЦИПИЕНТИ:
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Концентрат и разтворител за
инжекционна суспензия.
Концентрат: жълтеникаво кафяв
хомогенен концентрат.
Разтворител: бистър оранжев до червен
разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Пилета и ембрионирани яйца на пилета.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
За активна имунизация на 18-дневни
ембрионирани яйца или еднодневни
пилета:
•
за намаляване на смъртността,
клиничните признаци и лезиите,
предизвикани от вируса на
болестта Нюкасъл по птиците (NDV) и за
намаляване отделянето на вируса
•
за намал
                                
                                Read the complete document

Similar products

Active ingredient Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

ATC code QI01AD16

QI01AD16

Marketed by Ceva-Phylaxia Veterinary Biologicals Co. Ltd

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

INN (International Name) Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

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Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Estonian 01-01-1970
Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
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Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
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Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
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Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
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Patient Information leaflet Patient Information leaflet Polish 01-01-1970
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Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
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Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
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Public Assessment Report Public Assessment Report Swedish 01-01-1970
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Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
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Ultifend ND IBD