Purevax RCCh

Country: European Union

Language: Lithuanian

Source: EMA (European Medicines Agency)

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:

Katės

Therapeutic area:

Immunologicals už 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. Imunitetas buvo įrodytas praėjus 1 savaitei po pirminio vakcinavimo rinotracheito, kaliciviruso ir Chlamydophila felis komponentų. Imuniteto trukmė yra 1 metai po paskutinės (pakartotinės) vakcinacijos.

Product summary:

Revision: 8

Authorization status:

Panaikintas

Authorization date:

2005-02-22

Patient Information leaflet

                                B. INFORMACINIS LAPELIS
14
INFORMACINIS LAPELIS
PUREVAX RCCH
LIOFILIZATAS IR TIRPIKLIS INJEKCINEI SUSPENSIJAI RUOŠTI
1.
RINKODAROS TEISĖS TURĖTOJO IR UŽ VAISTO SERIJOS IŠLEIDIMĄ EEE
ŠALYSE ATSAKINGO GAMINTOJO, JEI JIE SKIRTINGI, PAVADINIMAS IR
ADRESAS
Rinkodaros
teisės turėtojas
:
MERIAL
29, avenue Tony Garnier
F-69007 Lyon
Prancūzija
Vaisto serijos gamintojas
:
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
Prancūzija
2.
VETERINARINIO VAISTO PAVADINIMAS
Purevax RCCh
Liofilizatas ir tirpiklis injekcinei suspensijai ruošti
3
.
VEIKLIOJI (-SIOS) IR KITOS MEDŽIAGOS
Vienoje vakcinos dozėje (1 ml) yra:
LIOFILIZATE:
nusilpnintų FHV F2 padermės kačių rinotracheito herpes virusų
.................................
≥
10
4,9
CCID
50
1
,
inaktyvuotų FCV 431 ir G1 padermių kačių kalicivirusų antigenų
............................
≥
2,0 IFA vienetai,
nusilpnintų 905 padermės
_ Chlamydophila felis_
................................................................
≥
10
3,0
EID
50
2
,
PAGALBINIŲ MEDŽIAGŲ:
gentamicino
...........................................................................................................
ne daugiau kaip 28 µg.
TIRPIKLYJE:
injekcinio vandens
.......................................................................................................................
iki 1 ml.
1
: 50 % ląstelių kultūros užkrečianti dozė.
2
: 50 % kiaušinių užkrečianti dozė.
4.
INDIKACIJOS
8 sav. amžiaus ir vyresnėms katėms aktyviai imunizuoti nuo:
-
kačių infekcinio rinotracheito, norint sumažinti klinikinius ligos
požymius,
-
kalicivirozės, norint sumažinti klinikinius ligos požymius ir
virusų išskyrimą į aplinką,
-
_Chlamydophila felis_
, norint sumažinti klinikinius ligos požymius.
Imunitetas rinotracheitui, kalicivirusams ir
_Chlamydophila felis_
susidaro praėjus 1 sav. po pirminės
vakcinacijos.
15
Imunitetas išlieka 1 metus po paskutinės vakcinacijos
(revakcinacijos).
5.
KONTRAINDIKACIJOS
Negalima vakcinuoti katingų kači
                                
                                Read the complete document

Summary of Product characteristics

                                I PRIEDAS
VETERINARINIO VAISTO APRAŠAS
1
1.
VETERINARINIO VAISTO PAVADINIMAS
Purevax RCCh, liofilizuota vakcina ir tirpiklis injekcinei suspensijai
ruošti
2.
KOKYBINĖ IR KIEKYBINĖ SUDĖTIS
Vienoje vakcinos dozėje (1 ml) yra:
LIOFILIZATE:
VEIKLIOSIOS MEDŽIAGOS:
nusilpnintų FHV F2 padermės kačių rinotracheito herpes virusų
.................................
≥
10
4,9
CCID
50
1
,
inaktyvuotų FCV 431 ir G1 padermių kačių kalicivirusų antigenų
............................
≥
2,0 IFA vienetai,
nusilpnintų 905 padermės
_ Chlamydophila felis_
................................................................
≥
10
3,0
EID
50
2
,
PAGALBINIŲ MEDŽIAGŲ:
gentamicino
...........................................................................................................
ne daugiau kaip 28 µg.
TIRPIKLYJE:
injekcinio vandens
.......................................................................................................................
iki 1 ml.
1
: 50 % ląstelių kultūros užkrečianti dozė.
2
: 50 % kiaušinių užkrečianti dozė.
Išsamų pagalbinių medžiagų sąrašą žr. 6.1 p.
3.
VAISTO FORMA
Liofilizatas ir tirpiklis injekcinei suspensijai ruošti.
4.
KLINIKINIAI DUOMENYS
4.1
PASKIRTIES GYVŪNŲ RŪŠYS
Katės.
4.2
NAUDOJIMO INDIKACIJOS NURODANT PASKIRTIES GYVŪNŲ RŪŠIS
8 sav. amžiaus ir vyresnėms katėms aktyviai imunizuoti nuo:
-
kačių infekcinio rinotracheito, norint sumažinti klinikinius ligos
požymius,
-
kalicivirozės, norint sumažinti klinikinius ligos požymius ir
virusų išskyrimą į aplinką,
-
_Chlamydophila felis_
, norint sumažinti klinikinius ligos požymius.
Imunitetas rinotracheitui, kalicivirusams ir
_ Chlamydophila felis_
susidaro praėjus 1 sav. po pirminės
vakcinacijos.
Imunitetas išlieka 1 metus po paskutinės vakcinacijos
(revakcinacijos).
4.3
KONTRAINDIKACIJOS
Negalima vakcinuoti katingų kačių.
Nerekomenduotina vakcinuoti kates laktacijos metu.
2
4.4
SPECIALIEJI NURODYMAI
Nėra.
4.5
SPECIALIOS NAUDOJIMO ATSARGUMO PRIEMONĖS
SPECIALIOS ATSARGU
                                
                                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

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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
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Public Assessment Report Public Assessment Report Czech 22-01-2015
Patient Information leaflet Patient Information leaflet Danish 23-01-2015
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Public Assessment Report Public Assessment Report Danish 22-01-2015
Patient Information leaflet Patient Information leaflet German 23-01-2015
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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
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Public Assessment Report Public Assessment Report Greek 22-01-2015
Patient Information leaflet Patient Information leaflet English 23-01-2015
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Public Assessment Report Public Assessment Report English 22-01-2015
Patient Information leaflet Patient Information leaflet French 23-01-2015
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Patient Information leaflet Patient Information leaflet Maltese 23-01-2015
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Purevax RCCh