Purevax RCCh

Country: European Union

Language: Dutch

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:

Cats

Therapeutic area:

Immunologicals voor 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. Onsets van immuniteit zijn aangetoond 1 week na de primaire vaccinatiekuur voor rhinotracheitis, calicivirus en Chlamydophila felis componenten. De duur van de immuniteit is 1 jaar na de laatste (her) vaccinatie.

Product summary:

Revision: 8

Authorization status:

teruggetrokken

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. BIJSLUITER
15
Medicinal product no longer authorised
BIJSLUITER VOOR:
PUREVAX RCCH
LYOFILISAAT EN OPLOSMIDDEL TER SUSPENSIE VOOR INJECTIE
1.
NAAM EN ADRES VAN DE HOUDER VAN DE VERGUNNING VOOR HET IN DE
HANDEL BRENGEN EN DE FABRIKANT VERANTWOORDELIJK VOOR
VRIJGIFTE, INDIEN VERSCHILLEND
Houder van de vergunning voor het in de handel brengen
:
MERIAL
29, avenue Tony Garnier
F-69007 Lyon
Frankrijk
Fabrikant verantwoordelijk voor vrijgifte
:
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 Saint Priest
Frankrijk
2.
BENAMING VAN HET DIERGENEESMIDDEL
Purevax RCCh
Lyofilisaat en oplosmiddel ter suspensie voor injectie
3.
GEHALTE AAN WERKZA(A)M(E) EN OVERIGE BESTANDD(E)L(EN)
Per dosis van 1 ml:
LYOFILISAAT:
Levend verzwakt feliene rhinotracheïtis herpesvirus (stam FHV F2)
............................
≥
10
4,9
CCID
50
1
Geïnactiveerde feliene Calicivirus antigenen (stammen FCV 431 en G1)
....................
≥
2,0 ELISA U.
Levend verzwakt
_Chlamydophila felis_
(stam 905)
............................................................
≥
10
3,0
EID
50
2
HULPSTOFFEN:
Gentamicine, hoogstens
..................................................................................................................
28 µg
OPLOSMIDDEL:
Water voor injectie
.......................................................................................................................
q.s. 1 ml
1
: cell culture infective dose 50%
2
: egg infective dose 50%
4.
INDICATIE(S)
Actieve immunisatie van katten van 8 weken en ouder:
-
tegen feliene virale rhinotracheïtis ter vermindering van klinische
symptomen,
-
tegen infecties met het calicivirus ter vermindering van klinische
symptomen en excretie,
-
tegen infecties met
_Chlamydophila felis_
ter vermindering van klinische symptomen.
16
Medicinal product no longer authorised
Immuniteit werd aangetoond vanaf 1 week na het basisvaccinatieschema
tegen de rhinotracheïtis,
calicivirus en
_Chlamydophila felis_
componenten.
De immuniteitsduur is 1 jaar
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
BIJLAGE I
SAMENVATTING VAN DE PRODUCTKENMERKEN
1
Medicinal product no longer authorised
1.
NAAM VAN HET DIERGENEESMIDDEL
Purevax RCCh lyofilisaat en oplosmiddel ter suspensie voor injectie
2.
KWALITATIEVE EN KWANTITATIEVE SAMENSTELLING
Per dosis van 1 ml:
LYOFILISAAT:
WERKZAME BESTANDDELEN:
Levend verzwakt feliene rhinotracheïtis herpesvirus (stam FHV F2)
............................
≥
10
4,9
CCID
50
1
Geïnactiveerde feliene Calicivirus antigenen (stammen FCV 431 en G1)
....................
≥
2,0 ELISA U.
Levend verzwakt
_Chlamydophila felis_
(stam 905)
............................................................
≥
10
3,0
EID
50
2
HULPSTOFFEN:
Gentamicine, hoogstens
...................................................................................................................
28 µg
OPLOSMIDDEL:
Water voor injectie
.......................................................................................................................
q.s. 1 ml
1
: cell culture infective dose 50%
2
: egg infective dose 50%
Zie rubriek 6.1 voor de volledige lijst van hulpstoffen.
3.
FARMACEUTISCHE VORM
Lyofilisaat en oplosmiddel ter suspensie voor injectie.
4.
KLINISCHE GEGEVENS
4.1
DOELDIERSOORT(EN)
Katten.
4.2
INDICATIES VOOR GEBRUIK MET SPECIFICATIE VAN DE DOELDIERSOORT(EN)
Actieve immunisatie van katten van 8 weken en ouder:
-
tegen feliene virale rhinotracheïtis ter vermindering van klinische
symptomen,
-
tegen infecties met het calicivirus ter vermindering van klinische
symptomen en excretie,
-
tegen infecties met
_Chlamydophila felis_
ter vermindering van klinische symptomen.
Immuniteit werd aangetoond vanaf 1 week na het basisvaccinatieschema
tegen de rhinotracheïtis,
calicivirus en
_Chlamydophila felis_
componenten.
De immuniteitsduur is 1 jaar na de laatste (her)vaccinatie.
4.3
CONTRA-INDICATIES
Niet gebruiken bij drachtige dieren.
Gebruik wordt afgeraden tijdens de lactatie.
2
Medicinal product no longer authorised
4.4
SPECIALE WAARSCHUWINGEN
Geen.
4.5
SPECIALE VOORZORG
                                
                                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
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 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