Purevax RCCh

Country: European Union

Language: German

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:

Katzen

Therapeutic area:

Immunologischen Arzneimitteln für 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. Anfänge der Immunität wurden 1 Woche nach der Grundimmunisierung für Rhinotracheitis, Calicivirus und Chlamydophila felis nachgewiesen. Die Dauer der Immunität beträgt 1 Jahr nach der letzten (Re-) Impfung.

Product summary:

Revision: 8

Authorization status:

Zurückgezogen

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. PACKUNGSBEILAGE
14
Medicinal product no longer authorised
GEBRAUCHSINFORMATION
PUREVAX RCCH
LYOPHILISAT UND LÖSUNGSMITTEL ZUR HERSTELLUNG EINER
INJEKTIONSSUSPENSION
1.
NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND,
WENN
UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE
VERANTWORTLICH IST
Zulassungsinhaber
MERIAL
29, Avenue Tony Garnier
F-69007 LYON
Frankreich
Für die Chargenfreigabe verantwortlicher Hersteller
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
Frankreich
2.
BEZEICHNUNG DES TIERARZNEIMITTELS
Purevax RCCh
Lyophilisat und Lösungsmittel zur Herstellung einer
Injektionssuspension.
3.
WIRKSTOFFE UND SONSTIGE BESTANDTEILE
Eine Dosis zu 1 ml enthält:
LYOPHILISAT:
Attenuiertes felines Rhinotracheitis-Virus (Herpesvirus Stamm FHV F2)
.............
≥
10
4,9
GKID
50
1
Inaktivierte feline Calicivirus-Antigene (Stämme FCV 431 und G1)
.....................
≥
2,0 ELISA-E.
Attenuierte
_Chlamydophila felis_
(Stamm 905) ………………………………..…….
≥
10
3,0
EID
50
2
SONSTIGER BESTANDTEIL:
Gentamicin, max.
…….………………….……………………………..……………….……
28 µg
LÖSUNGSMITTEL:
Wasser für Injektionszwecke
..............................................................................................
q.s. 1 ml
1
: Gewebekulturinfektiöse Dosis 50 %
2
: Eiinfektiöse Dosis 50 %
4.
ANWENDUNGSGEBIET(E)
Aktive Immunisierung von Katzen ab einem Alter von 8 Wochen:
-
gegen feline Rhinotracheitis (Herpesvirus-Infektion) zur Verringerung
klinischer Symptome,
-
gegen eine Calicivirus-Infektion zur Verringerung klinischer Symptome
und der
Erregerausscheidung,
-
gegen eine
_Chlamydophila felis_
-Infektion zur Verringerung klinischer Symptome,
Der Beginn der Immunität gegen Rhinotracheitis, Calicivirus und
_Chlamydophila felis _
wurde 1
Woche nach erfolgter Grundimmunisierung nachgewiesen.
15
Medicinal product no longer authorised
Die Dauer der Immunität beträgt 1 Jahr nach der le
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ANHANG I
ZUSAMMENFASSUNG DER MERKMALE DES TIERARZNEIMITTELS
1
Medicinal product no longer authorised
1.
BEZEICHNUNG DES TIERARZNEIMITTELS
Purevax RCCh, Lyophilisat und Lösungsmittel zur Herstellung einer
Injektionssuspension
2.
QUALITATIVE UND QUANTITATIVE ZUSAMMENSETZUNG
Eine Dosis zu 1 ml enthält:
LYOPHILISAT:
ARZNEILICH WIRKSAME BESTANDTEILE:
Attenuiertes felines Rhinotracheitis-Virus (Herpesvirus Stamm FHV F2)
..................
≥
10
4,9
GKID
50
1
Inaktivierte feline Calicivirus-Antigene (Stämme FCV 431 und G1)
..........................
≥
2,0 ELISA-E.
Attenuierte
_Chlamydophila felis_
(Stamm 905) …………………………………....….
≥
10
3,0
EID
50
2
SONSTIGER BESTANDTEIL:
Gentamicin, max.
…….………………….……………………………..……………….……
28 µg
LÖSUNGSMITTEL:
Wasser für Injektionszwecke
..............................................................................................
q.s. 1 ml
1
: Gewebekulturinfektiöse Dosis 50 %
2
: Eiinfektiöse Dosis 50 %
Eine vollständige Auflistung der sonstigen Bestandteile finden Sie
unter Abschnitt 6.1.
3.
DARREICHUNGSFORM
Lyophilisat und Lösungsmittel zur Herstellung einer
Injektionssuspension.
4.
KLINISCHE ANGABEN
4.1
ZIELTIERART(EN)
Katzen.
4.2
ANWENDUNGSGEBIETE UNTER ANGABE DER ZIELTIERART(EN)
Aktive Immunisierung von Katzen ab einem Alter von 8 Wochen:
-
gegen feline Rhinotracheitis (Herpesvirus-Infektion) zur Verringerung
klinischer Symptome,
-
gegen eine Calicivirus-Infektion zur Verringerung klinischer Symptome
und der
Erregerausscheidung,
-
gegen eine
_Chlamydophila felis_
-Infektion zur Verringerung klinischer Symptome.
Der Beginn der Immunität gegen Rhinotracheitis, Calicivirus und
_ Chlamydophila felis_
wurde 1
Woche nach erfolgter Grundimmunisierung nachgewiesen.
Die Dauer der Immunität beträgt 1 Jahr nach der letzten
(Wiederholungs-)Impfung.
4.3
GEGENANZEIGEN
Nicht bei trächtigen Tieren anwenden.
Die Anwendung während der Laktation wird nicht empfo
                                
                                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 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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Purevax RCCh