Purevax RCCh

Country: European Union

Language: Polish

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:

Koty

Therapeutic area:

Immunomodulatorów dla kotów,

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. Wystąpienie odporności wykazano 1 tydzień po pierwotnym cyklu szczepień w przypadku zapalenia nosa i tchawicy, kaliciwirusa i Chlamydophila felis. Czas trwania odporności wynosi 1 rok po ostatnim (ponownym) szczepieniu.

Product summary:

Revision: 8

Authorization status:

Wycofane

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. ULOTKA INFORMACYJNA
16
Medicinal product no longer authorised
ULOTKA INFORMACYJNA
PUREVAX RCCH
LIOFILIZAT I ROZPUSZCZALNIK DO SPORZĄDZANIA ZAWIESINY DO
WSTRZYKIWAŃ.
1.
NAZWA I ADRES PODMIOTU ODPOWIEDZIALNEGO ORAZ WYTWÓRCY
ODPOWIEDZIALNEGO ZA ZWOLNIENIE SERII, JEŚLI JEST INNY
Podmiot odpowiedzialny:
MERIAL
29 avenue Tony Garnier
F-69007 Lyon
Francja
Wytwórca odpowiedzialny za zwolnienie serii:
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation
69800 Saint Priest
Francja
2.
NAZWA PRODUKTU LECZNICZEGO WETERYNARYJNEGO
Purevax RCCh
Liofilizat i rozpuszczalnik do sporządzania zawiesiny do
wstrzykiwań.
3.
SKŁAD JAKOŚCIOWY I ILOŚCIOWY SUBSTANCJI CZYNNEJ (-CH) I INNYCH
SUBSTANCJI
Dawka 1-ml zawiera:
LIOFILIZAT:
Atenuowany herpeswirus zakaźnego zapalenia nosa i tchawicy kotów
(szczep FHV F2)≥10
4,9
CCID
50
1
Antygeny inaktywowanego kaliciwirusa kotów (szczepy FCV 431 i FCV G1)
............ ≥2,0 ELISA U.
Atenuowany
_Chlamydophila felis _
(szczep 905)
.................................................................
≥10
3,0
EID
50
2
WYPEŁNIACZ:
Gentamycyna, nie więcej niż
..........................................................................................................
28 µg
ROZPUSZCZALNIK:
Woda do
wstrzykiwań........................................................................................................
q.s. 1 ml
1
: dawka zakażająca 50% komórek hodowli
2
: dawka zakażająca 50% jaj
17
Medicinal product no longer authorised
4.
WSKAZANIA LECZNICZE
Czynne uodpornianie kotów w wieku 8 tygodni i starszych:
-
przeciwko wirusom zakaźnego wirusowego zapalenia nosa i tchawicy
kotów, w celu
zmniejszenia objawów klinicznych,
-
przeciwko kaliciwirozie kotów w celu zmniejszenia objawów
klinicznych i
siewstwa,
-
przeciwko zakażeniom
_Chlamydophila felis_
, w celu zmniejszenia objawów klinicznych,
Wykazano powstanie odporności tydzień po pierwszym szczepieniu
przeciwko zakaźnemu
wirusowemu zapaleniu nosa i tchawicy kotów, kaliciwi
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
ANEKS I
CHARAKTERYSTYKA PRODUKTU LECZNICZEGO WETERYNARYJNEGO
1
Medicinal product no longer authorised
1.
NAZWA PRODUKTU LECZNICZEGO WETERYNARYJNEGO
Purevax RCCh liofilizat i rozpuszczalnik do sporządzania zawiesiny do
wstrzykiwań
2.
SKŁAD JAKOŚCIOWY I ILOŚCIOWY PRODUKTU LECZNICZEGO
Dawka 1-ml zawiera:
LIOFILIZAT:
SUBSTANCJE CZYNNE:
Atenuowany herpeswirus zakaźnego zapalenia nosa i tchawicy kotów
(szczep FHV F2)≥10
4,9
CCID
50
1
Antygeny inaktywowanego kaliciwirusa kotów (szczepy FCV 431 i FCV G1)
............ ≥2,0 ELISA U.
Atenuowany
_Chlamydophila felis _
(szczep 905)
...................................................................≥10
3,0
EID
50
2
WYPEŁNIACZ:
Gentamycyna, nie więcej niż
..........................................................................................................
28 µg
ROZPUSZCZALNIK:
Woda do
wstrzykiwań……...............................................................................................
≥q.s. 1 ml
1
: dawka zakażająca 50% komórek hodowli
2
: dawka zakażająca 50% jaj
Wykaz wszystkich substancji pomocniczych, patrz punkt 6.1.
3.
POSTAĆ FARMACEUTYCZNA
Liofilizat i rozpuszczalnik do sporządzania zawiesiny do
wstrzykiwań.
4.
SZCZEGÓŁOWE DANE KLINICZNE
4.1
DOCELOWE GATUNKI ZWIERZĄT
Koty.
4.2
WSKAZANIA LECZNICZE DLA POSZCZEGÓLNYCH DOCELOWYCH GATUNKÓW ZWIERZĄT
Czynne uodpornianie kotów w wieku 8 tygodni i starszych:
-
przeciwko wirusom zakaźnego wirusowego zapalenia nosa i tchawicy
kotów, w celu
zmniejszenia objawów klinicznych,
-
przeciwko kaliciwirozie kotów w celu zmniejszenia objawów
klinicznych i
siewstwa,
-
przeciwko zakażeniom
_Chlamydophila felis_
, w celu zmniejszenia objawów klinicznych,
Wykazano powstanie odporności tydzień po pierwszym szczepieniu
przeciwko zakaźnemu
wirusowemu zapaleniu nosa i tchawicy kotów, kaliciwirozie i
_Chlamydophila Felis. _
Odporność utrzymuje
się przez 1 rok po ostatnim szczepieniu/szczepieniu przypominającym.
4.3
PRZECIWWSKAZANIA
Nie stosować 
                                
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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

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Patient Information leaflet Patient Information leaflet Bulgarian 23-01-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 23-01-2015
Public Assessment Report Public Assessment Report Bulgarian 22-01-2015
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
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Public Assessment Report Public Assessment Report French 22-01-2015
Patient Information leaflet Patient Information leaflet Italian 23-01-2015
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Patient Information leaflet Patient Information leaflet Latvian 23-01-2015
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Patient Information leaflet Patient Information leaflet Lithuanian 23-01-2015
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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
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Patient Information leaflet Patient Information leaflet Dutch 23-01-2015
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Patient Information leaflet Patient Information leaflet Portuguese 23-01-2015
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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
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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