Circovac

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
08-12-2021
Public Assessment Report Public Assessment Report (PAR)
19-09-2017

Active ingredient:

инактивиран свински цирковирус тип 2 (PCV2)

Available from:

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

ATC code:

QI09AA07

INN (International Name):

adjuvanted inactivated vaccine against porcine circovirus type 2

Therapeutic group:

Прасета (свинчета и свине майки)

Therapeutic area:

Имунологични средства за суици

Therapeutic indications:

GiltsPassive имунизация на свине майки и свине, чрез коластрата, след активна имунизация свине и ремонтни прасета, за да се намали огнища в от лимфоидни тъкани, свързани с ЦВС2 инфекция и като помощно средство за намаляване на ЦВС2-свързана смъртност. PigletsActive имунизация на прасета за намаляване на фекални екскреция ЦВС2 и вирусния товар в кръвта, и като помощ за намаляване на ЦВС2-свързани с клинични симптоми, включително и изтощение, загуба на тегло и смъртност, а също и за намаляване на вирусния товар и загуби в от лимфоидни тъкани, свързани с инфекция в pcv2.

Product summary:

Revision: 12

Authorization status:

упълномощен

Authorization date:

2007-06-21

Patient Information leaflet

                                17
B. ЛИСТОВКА
18
ЛИСТОВКА:
CIRCOVAC
емулсия и суспензия за инжекционна
емулсия за прасета
1.
ИМЕ И ПОСТОЯНEН АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА ЗА УПОТРЕБА
И НА ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
Притежател на лиценза за употреба:
CEVA-Phylaxia Co. Ltd., Szállás u. 5., 1107 Budapest, Унгария
Производител, отговорен за
освобождаване на партидата:
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint
Priest, France
CEVA-Phylaxia Co. Ltd., Szállás u. 5., 1107 Budapest, Унгария
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Circovac
Емулсия и суспензия за инжекционна
емулсия за прасета.
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА СУБСТАНЦИЯ И
ЕКСЦИПИЕНТИТЕ
Бледо опалесцираща течност преди
разтваряне
Всеки ml от готовата вакснина съдържа:
АКТИВНА СУБСТАНЦИЯ:
Инактивиран цирковирус тип 2 по
прасетата (PCV2) ...............................

1.8 log10 ELISA Units
АДЖУВАНТ:
Леко парафиново масло
..............................................................................................247
до 250.5 mg
ЕКСЦИПИЕНТИ:
Тиомерсал
...................................................................................................................................
0.10 mg
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
ПРАСЕТА:
Активна имунизация на прасета за
намаляване на екскрецията на PCV2 с
фекалиите и
вирусното „напрежение” в кръвта и за
намаляване на клиничните приз
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИ КА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Circovac емулсия и суспензия за
инжекционна емулсия за прасета.
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки ml от готовата ваксина съдържа:
АКТИВНА СУБСТАНЦИЯ:
Инактивиран цирковирус тип 2 по
прасетата (PCV2) ...............................

1.8 log10 ELISA Units
АДЖУВАНТ:
Леко парафиново
масло................................................................................................247
до 250.5 mg
ЕКСЦИПИЕНТИ:
Тиомерсал
..................................................................................................................................
0.10 mg
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Емулсия и суспензия за инжекционна
емулсия.
Бледо опалесцираща течност преди
разтваряне.
Разтворената ваксина е хомогенна бяла
емулсия.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Прасета (ремонтни прасета, свине и
прасета след 3 седмична възраст).
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
, ОПРЕДЕЛЕНИ ЗА ОТДЕЛНИТЕ ВИДОВЕ
ЖИВОТНИ
ПРАСЕТА:
Активна имунизация на прасета за
намаляване на екскрецията на PCV2 с
фекалиите и
вирусното „напрежение” в кръвта и за
намаляване на клиничните признаци
свързани с PCV2,
включително слабеен
                                
                                Read the complete document

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Active ingredient инактивиран свински цирковирус тип 2 (PCV2)

инактивиран свински цирковирус тип 2 (PCV2)

ATC code QI09AA07

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Marketed by CEVA-Phylaxia Oltóanyagtermelõ Zrt.

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

INN (International Name) adjuvanted inactivated vaccine against porcine circovirus type 2

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Circovac