Purevax RCCh

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
23-01-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
23-01-2015
Public Assessment Report Public Assessment Report (PAR)
22-01-2015

Active ingredient:

attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain)

Available from:

Merial

ATC code:

QI06AH

INN (International Name):

vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections

Therapeutic group:

Котки

Therapeutic area:

Имуномодулатори за котки,на

Therapeutic indications:

Active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs and excretion;against Chlamydophila felis infection to reduce clinical signs. Условията на имунитета са демонстрирани 1 седмица след основния ваксинационен курс за ринотрахеит, калицивирус и Chlamydophila felis компоненти. Продължителността на имунитета е 1 година след последната (повторна) ваксинация.

Product summary:

Revision: 8

Authorization status:

Отменено

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. ЛИСТОВКА ЗА УПОТРЕБА
14
Medicinal product no longer authorised
ЛИСТОВКА ЗА УПОТРЕБА :
PUREVAX RCCH
ЛИОФИЛИЗИРАНА ВАКСИНА И РАЗТВОРИТЕЛ
ЗА СУСПЕНЗИЯ ЗА ИНЖЕКТИРАНЕ
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
:
MERIAL
29, avenue Tony Garnier
F-69007 Lyon
France
Упълномощен производител, отговорен
за освобождаване на партидата
:
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
France
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Purevax RCCh
Лиофилизирана ваксина и разтворител
за суспензия за инжектиране
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА(ИТЕ)
СУБСТАНЦЯ(ИИ) И ПОМОЩНИТЕ
ВЕЩЕСТВА
За доза от 1мл:
ЛИОФИЛИЗИРАНА ВАКСИНА
Атенюиран вирус на котешки херпесен
ринотрахеит (щам FHV F2) .......................
≥
10
4.9
CCID
50
1
Инактивирани антигени на котешки
калицивирус (щамове FCV 431 и G1) ...........
≥
2.0 ELISA U.
Атенюирана
_Chlamydophila felis_
(щам 905)
..................................................................
≥
10
3.0
EID
50
2
ЕКСЦИПИЕНТ:
Гентамицин, най-много
.................................................................................................................
28 µg
РАЗТВОРИТЕЛ:
Вода за инжектиране, до
.................................................................................................................
1 
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
1
Medicinal product no longer authorised
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Purevax RCCh лиофилизирана ваксина и
разтворител за суспензия за
инжектиране
2.
КОЛИЧЕСТВЕН И КАЧЕСТВЕН СЪСТАВ
За доза от 1мл:
ЛИОФИЛИЗИРАНА ВАКСИНА
АКТИВНИ СУБСТАНЦИИ:
Атенюиран вирус на котешки херпесен
ринотрахеит (щам FHV F2) .......................
≥
10
4.9
CCID
50
1
Инактивирани антигени на котешки
калицивирус (щамове FCV 431 и G1) ...........
≥
2.0 ELISA U.
Атенюирана
_Chlamydophila felis_
(щам 905)
..................................................................
≥
10
3.0
EID
50
2
ЕКСЦИПИЕНТ:
Гентамицин, най-много
.................................................................................................................
28 µg
РАЗТВОРИТЕЛ:
Вода за инжектиране, до
.................................................................................................................
1 ml
1
: клетъчно културална инфекциозна
доза 50%
2
: яйчна инфекциозна доза 50%
За пълен списък на ексципиентите виж
секция 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Лиофилизирана ваксина и разтворител
за инжективна суспензия.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Котки.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ ЗА ОТДЕЛНИТЕ
ВИДОВЕ ЖИВОТНИ
Активна имунизация на котки след
навършване на
                                
                                Read the complete document

Similar products

Active ingredient attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain)

attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain)

ATC code QI06AH

QI06AH

Marketed by Merial

Merial

INN (International Name) vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections

vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 23-01-2015
Summary of Product characteristics Summary of Product characteristics Spanish 23-01-2015
Public Assessment Report Public Assessment Report Spanish 22-01-2015
Patient Information leaflet Patient Information leaflet Czech 23-01-2015
Summary of Product characteristics Summary of Product characteristics Czech 23-01-2015
Public Assessment Report Public Assessment Report Czech 22-01-2015
Patient Information leaflet Patient Information leaflet Danish 23-01-2015
Summary of Product characteristics Summary of Product characteristics Danish 23-01-2015
Public Assessment Report Public Assessment Report Danish 22-01-2015
Patient Information leaflet Patient Information leaflet German 23-01-2015
Summary of Product characteristics Summary of Product characteristics German 23-01-2015
Public Assessment Report Public Assessment Report German 22-01-2015
Patient Information leaflet Patient Information leaflet Estonian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Estonian 23-01-2015
Public Assessment Report Public Assessment Report Estonian 22-01-2015
Patient Information leaflet Patient Information leaflet Greek 23-01-2015
Summary of Product characteristics Summary of Product characteristics Greek 23-01-2015
Public Assessment Report Public Assessment Report Greek 22-01-2015
Patient Information leaflet Patient Information leaflet English 23-01-2015
Summary of Product characteristics Summary of Product characteristics English 23-01-2015
Public Assessment Report Public Assessment Report English 22-01-2015
Patient Information leaflet Patient Information leaflet French 23-01-2015
Summary of Product characteristics Summary of Product characteristics French 23-01-2015
Public Assessment Report Public Assessment Report French 22-01-2015
Patient Information leaflet Patient Information leaflet Italian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Italian 23-01-2015
Public Assessment Report Public Assessment Report Italian 22-01-2015
Patient Information leaflet Patient Information leaflet Latvian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Latvian 23-01-2015
Public Assessment Report Public Assessment Report Latvian 22-01-2015
Patient Information leaflet Patient Information leaflet Lithuanian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 23-01-2015
Public Assessment Report Public Assessment Report Lithuanian 22-01-2015
Patient Information leaflet Patient Information leaflet Hungarian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Hungarian 23-01-2015
Public Assessment Report Public Assessment Report Hungarian 22-01-2015
Patient Information leaflet Patient Information leaflet Maltese 23-01-2015
Summary of Product characteristics Summary of Product characteristics Maltese 23-01-2015
Public Assessment Report Public Assessment Report Maltese 22-01-2015
Patient Information leaflet Patient Information leaflet Dutch 23-01-2015
Summary of Product characteristics Summary of Product characteristics Dutch 23-01-2015
Public Assessment Report Public Assessment Report Dutch 22-01-2015
Patient Information leaflet Patient Information leaflet Polish 23-01-2015
Summary of Product characteristics Summary of Product characteristics Polish 23-01-2015
Public Assessment Report Public Assessment Report Polish 22-01-2015
Patient Information leaflet Patient Information leaflet Portuguese 23-01-2015
Summary of Product characteristics Summary of Product characteristics Portuguese 23-01-2015
Public Assessment Report Public Assessment Report Portuguese 22-01-2015
Patient Information leaflet Patient Information leaflet Romanian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Romanian 23-01-2015
Public Assessment Report Public Assessment Report Romanian 22-01-2015
Patient Information leaflet Patient Information leaflet Slovak 23-01-2015
Summary of Product characteristics Summary of Product characteristics Slovak 23-01-2015
Public Assessment Report Public Assessment Report Slovak 22-01-2015
Patient Information leaflet Patient Information leaflet Slovenian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 23-01-2015
Public Assessment Report Public Assessment Report Slovenian 22-01-2015
Patient Information leaflet Patient Information leaflet Finnish 23-01-2015
Summary of Product characteristics Summary of Product characteristics Finnish 23-01-2015
Public Assessment Report Public Assessment Report Finnish 22-01-2015
Patient Information leaflet Patient Information leaflet Swedish 23-01-2015
Summary of Product characteristics Summary of Product characteristics Swedish 23-01-2015
Public Assessment Report Public Assessment Report Swedish 22-01-2015

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Alerts Purevax RCCh attenuated feline rhinotracheitis herpesvirus vaccine against viral rhinotracheitis,

Purevax RCCh attenuated feline rhinotracheitis herpesvirus vaccine against viral rhinotracheitis,

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Purevax RCCh