Purevax RCCh

Country: European Union

Language: Slovenian

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:

Mačke

Therapeutic area:

Immunologicals za skupin 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. Na imunski sistem je bil dokazan 1 teden po osnovnem cepljenju za rinotraheitis, kalicivirus in komponento Chlamydophila felis. Trajanje imunosti je 1 leto po zadnjem (ponovnem) cepljenju.

Product summary:

Revision: 8

Authorization status:

Umaknjeno

Authorization date:

2005-02-22

Patient Information leaflet

                                Medicinal product no longer authorised
B. NAVODILO ZA UPORABO
15
Medicinal product no longer authorised
NAVODILO ZA UPORABO ZA:
PUREVAX RCCH
LIOFILIZAT IN VEHIKEL ZA SUSPENZIJO ZA INJICIRANJE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Imetnik dovoljenja za promet z zdravilom
MERIAL
29, avenue Tony Garnier
F-69007 Lyon
Francija
Izdelovalec, odgovoren za sprostitev serije
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
Francija
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Purevax RCCh
Liofilizat in vehikel za suspenzijo za injiciranje
3.
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
V odmerku po 1 ml:
LIOFILIZAT:
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2)
............................................
≥
10
4,9
CCID
50
1
Inaktivirani antigeni kalici virusa mačk (seva FCV 431 in G1)
.......................
≥
2,0 enot v testu ELISA
Atenuirana
_Chlamydophila felis_
(sev 905)
........................................................................
≥
10
3,0
EID
50
2
POMOŽNA SNOV:
Gentamicin, največ
...........................................................................................................................
18 µg
VEHIKEL:
Voda za
injiciranje.........................................................................................................................
q.s. 1ml
1
: 50% infektivni odmerek za celično kulturo
2
: 50% infektivni odmerek za embrionirana kokošja jajca
4.
INDIKACIJA(E)
Aktivna imunizacija 8 tednov starih mačk in starejših:
-
Proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj
-
Proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj in
zmanjšanje izločanja virusov,
-
Proti okužbam s C
_hlamydophila felis _
, za ublažitev kliničnih znamenj.
Imunost proti kužnemu rinotraheitisu,kalicivirozi mačk in
_Chlamydophila felis _
nastopi 1 teden po
osnovnem cepljenju.
16
Medicinal pro
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
1
Medicinal product no longer authorised
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Purevax RCCh liofilizat in vehikel za suspenzijo za injiciranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
V odmerku po 1 ml:
LIOFILIZAT:
ZDRAVILNE UČINKOVINE:
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2)
............................................
≥
10
4,9
CCID
50
1
Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in G1)
.........................
≥
2,0 enot v testu ELISA
Atenuirana
_Chlamydophila felis_
(sev 905)
........................................................................
≥
10
3,0
EID
50
2
POMOŽNA SNOV:
Gentamicin, največ
...........................................................................................................................
28 µg
VEHIKEL:
Voda za
injiciranje........................................................................................................................
q.s. 1 ml
1
: 50% infektivni odmerek za celično kulturo
2
: 50% infektivni odmerek za embrionirana kokošja jajca
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Liofilizat in vehikel za suspenzijo za injiciranje.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Mačke.
4.2
INDIKACIJE ZA UPORABO
Aktivna imunizacija 8 tednov starih mačk in starejših:
-
Proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj,
-
Proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj in
zmanjšanje izločanja virusov,
-
Proti okužbam s C
_hlamydophila felis _
, za ublažitev kliničnih znamenj.
Imunost proti kužnemu rinotraheitisu, kalicivirusu mačk in
_Chlamydophila felis_
nastopi 1 teden po
osnovnem cepljenju.
Živali so odporne eno leto po zadnjem cepljenju.
4.3
KONTRAINDIKACIJE
Ne uporabite v obdobju brejosti.
Uporaba ni priporočljiva v obdobju laktacije.
2
Medicinal product no longer authorised
4.4
POSEBNA OPOZORILA
Jih ni.
4.5
POSEBNI PREVIDNOSTNI UKREPI
POSEBNI P
                                
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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
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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
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Public Assessment Report Public Assessment Report French 22-01-2015
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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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Patient Information leaflet Patient Information leaflet Polish 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
Summary of Product characteristics Summary of Product characteristics Slovak 23-01-2015
Public Assessment Report Public Assessment Report Slovak 22-01-2015
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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