Purevax RCCh

Country: European Union

Language: Greek

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:

Γάτες

Therapeutic area:

Ανοσολογικά για αιλουροειδών,

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. Τα αντισώματα ανοσίας έχουν αποδειχθεί 1 εβδομάδα μετά τον κύριο εμβολιασμό για ρινοτραχειίτιδα, καλυκοϊό και συστατικά Chlamydophila felis. Η διάρκεια της ανοσίας είναι 1 έτος μετά τον τελευταίο (επαν) εμβολιασμό.

Product summary:

Revision: 8

Authorization status:

Αποτραβηγμένος

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ
14
Medicinal product no longer authorised
ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ ΓΙΑ:
PUREVAX RCCH
ΛΥΟΦΙΛΟΠΟΙΗΜΈΝΟ ΥΛΙΚΌ ΚΑΙ ΔΙΑΛΎΤΗΣ
ΓΙΑ ΕΝΈΣΙΜΟ ΕΝΑΙΏΡΗΜΑ
1.
ΟΝΟΜΑ ΚΑΙ ΔΙΕΥΘΥΝΣΗ ΤΟΥ ΚΑΤΟΧΟΥ ΤΗΣ
ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ ΚΑΙ
ΤΟΥ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΠΑΡΑΓΩΓΗΣ ΠΟΥ
ΕΙΝΑΙ ΥΠΕΥΘΥΝΟΣ ΓΙΑ ΤΗΝ
ΑΠΟΔΕΣΜΕΥΣΗ ΠΑΡΤΙΔΩΝ ΣΤΟΝ ΕΟΧ, ΕΦΟΣΟΝ
ΕΙΝΑΙ ΔΙΑΦΟΡΕΤΙΚΟΙ
Κάτοχος της άδειας κυκλοφορίας:
MERIAL
29, avenue Tony Garnier
69007 Lyon
Γαλλία
Παραγωγός υπεύθυνος για την
αποδέσμευση παρτίδων:
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 Saint Priest
Γαλλία
2.
ΟΝΟΜΑΣΙΑ ΤΟΥ ΚΤΗΝΙΑΤΡΙΚΟΥ
ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΙΟΝΤΟΣ
Purevax RCCh
Λυοφιλοποιημένο υλικό και διαλύτης
για ενέσιμο εναιώρημα.
3.
ΣΥΝΘΕΣΗ ΣΕ ΔΡΑΣΤΙΚΟ(Α) ΣΥΣΤΑΤΙΚΟ(Α) ΚΑΙ
ΑΛΛΕΣ ΟΥΣΙΕΣ
Ανά δόση του 1 ml:
ΛΥΟΦΙΛΟΠΟΙΗΜΈΝΟ ΥΛΙΚΌ:
Εξασθενημένος ερπητοϊός
ρινοτραχειίτιδας της γάτας (στέλεχος
FHV F2) ..................
≥
10
4,9
CCID
50
1
Αδρανοποιημένα αντιγόνα καλυκοΐωσης
της γάτας (στελέχη FCV 431 και G1) ..........
≥
2,0 ELISA U.
Εξασθενημένη
_Chlamydophila felis_
(στέλεχος 905)
.........................................................
≥
10
3,0
EID
50
2
ΔΙΑΛΎΤΗΣ:
Ύδωρ για
ενέσιμα………………………………………………………………………………q.s.
1ml
1
: μολυσματική δόση
κυτταροκαλλιέργειας 50%
2
: μολυσματική δόση αυγών 50%
4.
Ε
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ΠΑΡΑΡΤΗΜΑ Ι
ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ
ΠΡΟΙΟΝΤΟΣ
1
Medicinal product no longer authorised
1.
ΟΝΟΜΑΣΙΑ ΤΟΥ ΚΤΗΝΙΑΤΡΙΚΟΥ
ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΙΟΝΤΟΣ
Purevax RCCh λυοφιλοποιημένο υλικό και
διαλύτης για ενέσιμο εναιώρημα
2.
ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ
Ανά δόση του 1 ml:
ΛΥΟΦΙΛΟΠΟΙΗΜΈΝΟ ΥΛΙΚΌ:
ΔΡΑΣΤΙΚΆ ΣΥΣΤΑΤΙΚΆ:
Εξασθενημένος ερπητοϊός
ρινοτραχειίτιδας της γάτας (στέλεχος
FHV F2) ..................
≥
10
4,9
CCID
50
1
Αδρανοποιημένα αντιγόνα καλυκοΐωσης
της γάτας (στελέχη FCV 431 και G1) ..........
≥
2,0 ELISA U.
Εξασθενημένη
_Chlamydophila felis_
(στέλεχος 905)
.........................................................
≥
10
3,0
EID
50
2
ΔΙΑΛΎΤΗΣ:
Ύδωρ για
ενέσιμα………………………………………………………………………………q.s.
1 ml
1
: μολυσματική δόση
κυτταροκαλλιέργειας 50%
2
: μολυσματική δόση αυγών 50%
Βλ. πλήρη κατάλογο εκδόχων στο
κεφάλαιο 6.1
3.
ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ
Λυοφιλοποιημένο υλικό και διαλύτης
για ενέσιμο εναιώρημα.
4.
ΚΛΙΝΙΚΑ ΣΤΟΙΧΕΙΑ
4.1
ΕΊΔΗ ΖΏΩΝ
Γάτες.
4.2
ΘΕΡΑΠΕΥΤΙΚΈΣ ΕΝΔΕΊΞΕΙΣ
ΠΡΟΣΔΙΟΡΊΖΟΝΤΑΣ ΤΑ ΕΊΔΗ ΖΏΩΝ
Ενεργητική ανοσοποίηση σε γάτες
ηλικίας 8 εβδομάδων και άνω:
-
κατά της ιογενούς ρινοτραχειίτιδας
της γάτας για τη μείωση των κλινικών
συμπτωμάτων,
-
κατά της λοίμωξης από καλυκοϊό για τη

                                
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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

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 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