Purevax RCCh

Country: European Union

Language: Finnish

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
23-01-2015
Download Summary of Product characteristics (SPC)
23-01-2015
Download 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:

Kissat

Therapeutic area:

Immunologisia valmisteita varten felidae,

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. Immuunijärjestelmää on osoitettu 1 viikon kuluttua rihotrakeiitti-, kalicivirus- ja Chlamydophila felis -komponenttien ensisijaisesta rokotuskurssista. Immuniteetin kesto on yksi vuosi viimeisen (uudelleen) rokottamisen jälkeen.

Product summary:

Revision: 8

Authorization status:

peruutettu

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. PAKKAUSSELOSTE
15
Medicinal product no longer authorised
PAKKAUSSELOSTE
PUREVAX RCCH
INJEKTIOKUIVA-AINE, KYLMÄKUIVATTU, JA LIUOTIN, SUSPENSIOTA VARTEN.
1.
MYYNTILUVAN HALTIJAN NIMI JA OSOITE SEKÄ ERÄN VAPAUTTAMISESTA
VASTAAVAN VALMISTAJAN NIMI JA OSOITE EUROOPAN TALOUSALUEELLA,
JOS ERI
Myyntiluvan haltija
:
MERIAL
29 avenue Tony Garnier
F-69007 LYON
RANSKA
Valmistaja:
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
RANSKA
2.
ELÄINLÄÄKEVALMISTEEN NIMI
Purevax RCCh
Injektiokuiva-aine, kylmäkuivattu, ja liuotin, suspensiota varten.
3.
VAIKUTTAVAT JA MUUT AINEET
1 ml:n annos sisältää:
KYLMÄKUIVATTU INJEKTIOKUIVA-AINE:
Heikennettyä kissan rinotrakeiittiherpesvirusta (FHV-viruksen
F2-kantaa) ..................
≥
10
4.9
CCID
50
1
Inaktivoitua kissan kalikiviruksen antigeenia (FCV 431- ja G1-kantoja)
......................
≥
2.0 ELISA U.
Heikennettyä
_Chlamydophila felis _
(905-kantaa)
................................................................
≥
10
3.0
EID
50
2
APUAINEET:
Gentamysiinia enintään
.............................................................................................................
28 mikrog
LIUOTIN:
Injektionesteisiin käytettävä vesi
.................................................................................................
q.s. 1 ml
1
: 50 % soluviljelmästä infektoiva annos
2
: 50 % munista infektoiva annos
4.
KÄYTTÖAIHEET
Kahdeksanviikkoisten ja sitä vanhempien kissojen aktiivinen
immunisointi:
-
kissan rinotrakeiittivirusinfektota vastaan kliinisten oireiden
vähentämiseksi
-
kalikivirusinfektiota vastaan kliinisten oireiden ja viruserityksen
vähentämiseksi
-
_Chlamydophila felis_
-infektiota vastaan kliinisten oireiden vähentämiseksi
16
Medicinal product no longer authorised
On osoitettu, että immuniteettisuoja kehittyy 1 viikon kuluttua
perusrokotuksesta rinotrakeiitti-,
kalikivirus- ja
_Chlamydophila felis_
-komponentteja vastaan.
Immuniteetin kesto on yksi vuosi viimeisestä (u
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
LIITE I
VALMISTEYHTEENVETO
1
Medicinal product no longer authorised
1.
ELÄINLÄÄKKEEN NIMI
Purevax RCCh injektiokuiva-aine, kylmäkuivattu, ja liuotin,
suspensiota varten
2.
LAADULLINEN JA MÄÄRÄLLINEN KOOSTUMUS
1 ml:n annos sisältää:
KYLMÄKUIVATTU INJEKTIOKUIVA-AINE:
VAIKUTTAVAT AINEET:
Heikennettyä kissan rinotrakeiittiherpesvirusta (FHV-viruksen
F2-kantaa) ..................
≥
10
4.9
CCID
50
1
Inaktivoitua kissan kalikiviruksen antigeenia (FCV 431- ja G1-kantoja)
......................
≥
2.0 ELISA U.
Heikennettyä
_Chlamydophila felis _
(905-kantaa)
................................................................
≥
10
3.0
EID
50
2
APUAINEET:
Gentamysiinia enintään
.............................................................................................................
28 mikrog
LIUOTIN:
Injektionesteisiin käytettävä vesi
.................................................................................................
q.s. 1 ml
1
: 50 % soluviljelmästä infektoiva annos
2
: 50 % munista infektoiva annos
Täydellinen apuaineluettelo, katso kohta 6.1.
3.
LÄÄKEMUOTO
Injektiokuiva-aine, kylmäkuivattu, ja liuotin, suspensiota varten.
4.
KLIINISET TIEDOT
4.1
KOHDE-ELÄINLAJI(T)
Kissa.
4.2
KÄYTTÖAIHEET KOHDE-ELÄINLAJEITTAIN
Kahdeksanviikkoisten ja sitä vanhempien kissojen aktiivinen
immunisointi:
-
kissan rinotrakeiittivirusinfektota vastaan kliinisten oireiden
vähentämiseksi
-
kalikivirusinfektiota vastaan kliinisten oireiden ja viruserityksen
vähentämiseksi
-
_Chlamydophila felis_
-infektiota vastaan kliinisten oireiden vähentämiseksi
On osoitettu, että immuniteettisuoja kehittyy 1 viikon kuluttua
perusrokotuksesta rinotrakeiitti-,
kalikivirus- ja
_Chlamydophila felis_
-komponentteja vastaan.
Immuniteetin kesto on yksi vuosi viimeisestä (uusinta)rokotuksesta.
4.3
VASTA-AIHEET
Ei saa käyttää tiineyden aikana.
Käyttöä ei suositella laktaation aikana.
2
Medicinal product no longer authorised
4.4
ERITYISVAROITUKSET
Ei ole
4.5
KÄYTTÖÖ
                                
                                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 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
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
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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
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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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Public Assessment Report Public Assessment Report Dutch 22-01-2015
Patient Information leaflet Patient Information leaflet Polish 23-01-2015
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Patient Information leaflet Patient Information leaflet Portuguese 23-01-2015
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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 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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Purevax RCCh