Nobilis Influenza H7N1

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
26-07-2010
Summary of Product characteristics Summary of Product characteristics (SPC)
26-07-2010
Public Assessment Report Public Assessment Report (PAR)
26-07-2010

Active ingredient:

antiġenu tal-virus tal-influwenza tat-tjur mhux attivat tas-sottotip H7N1 (tensjoni, A / CK / Italja / 473/99)

Available from:

Intervet International BV

ATC code:

QI01AA23

INN (International Name):

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

Therapeutic group:

Chicken; Ducks

Therapeutic area:

Immunoloġiċi għall-għasafar

Therapeutic indications:

Għal immunizzazzjoni attiva ta 'tiġieġ u papri kontra l-influwenza tat-tjur tat-tip A, sottotip H7N1. L-effikaċja ġiet evalwata fuq il-bażi tar-riżultati preliminari fit-tiġieġ u t-trombi ċrieki. Fit-tiġieġ, it-tnaqqis tas-sinjali kliniċi, il-mortalità, it-tneħħija u t-trażmissjoni tal-virus wara l-isfida ntwerew b'ġimgħatejn wara t-tilqima b'doża waħda. Fil-papri, tnaqqis ta 'eskrezzjoni u trażmissjoni ta' virus wara l-isfida ntwerew b'ġimgħatejn wara tilqima b'doża waħda. Għalkemm ma ġietx investigata b'din l partikolari AI-istrejn tal-vaċċin, studji mwettqa bi strejns oħra juru li l-livelli ta'protezzjoni ta'antikorpi fis-serum titres jkun mistenni li jippersistu fil-flieles għal tal-anqas 12-il xahar wara amministrazzjoni ta ' żewġ dożi tal-vaċċin. It-tul tal-immunità fil-papri mhux magħruf.

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2007-05-14

Patient Information leaflet

                                Prodott mediċinali li m’għadux awtorizzat
19
B. FULJETT TA' TAGĦRIF FIL-PAKKETT
Prodott mediċinali li m’għadux awtorizzat
20
FULJETT TA’ TAGĦRIF FIL-PAKKETT
NOBILIS INFLUENZA H5N2
EMULSJONI GĦAL INJEZZJONI
1
L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-
KUMMERĊ, U L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI
TAL-MANIFATTURA RESPONSABBLI LI JĦALLI L-KONSENJA TMUR FIS-
SUQ , JEKK DIFFERENTI
Sid l-Awtorizzazzjoni tal-Kummerċ:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer.
The Netherlands
Manifattur li jħalli l-konsenja tmur fis-suq:
Intervet International B.V.
Wim de Körverstraat 35
NL-5831 AN Boxmeer.
The Netherlands
2.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Nobilis Influenza H7N1
emulsjoni għal injezzjoni
3.
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) U INGREDJENT(I) OĦRA
Doża ta’ 0.5ml fiha:
Antiġen sħiħ inattivat tal-virus tal-influwenza avjarja, subtip
H7N1 (strejn,
A/CK/Italy/473/99), li jinduċi titru ta’ HI ta’ ≥6.0log
2
, kif ittestjat għat-test ta’ potenza.
ADJUVANT
Paraffina likwida ħafifa 234.8mg/0.5ml
4.
INDIKAZZJONI
Għal immunizzazzjoni attiva fil-flieles u l-papri kontra l-Influwenza
avjarja tip A, subtip
H7N1.
L-effikaċja kienet evalwata abbażi ta’riżultati preliminari
fil-flieles u . Tnaqqis ta’ sinjali
kliniċi,
mortalita
u
tneħħija
tal-virus
wara
tlaqqiegħ
mal-vaċċin
ġew
murija
fi
żmien
\ew[ ġimgħat wara t-tilqim.
Fil-papri, tnaqqis fit tneħħija tal-virus ġew murija fi żmien
ġimgħatejn wara t-tilqima wa]da
G]alkemm ma [ietx investigata b’din l-istrejn partikulari A1, studji
mwettqa b’istrejns o]ra
juru li
Prodott mediċinali li m’għadux awtorizzat
21
anti-korpi
fis-sirum
hu
mistenni
li
jippersistu
għal
tal-anqas
12
–il
xahar
wara
amministrazzjoni ta’ żewg dożi tal-vaċċin. I\-zmien ta’ kemm
idum l-imunita fil-papri mhix
mag]rufa.
5.
KONTRAINDIKAZZJONIJIET
Xejn.
6.
EFFETTI MHUX MIXTIEQA
Is-sigurta tal-prodott ġiet maħduma abbażi ta’ riżultati
preliminari fil-flieles. Nefħa mifruxa
ta’ 
                                
                                Read the complete document

Summary of Product characteristics

                                Prodott mediċinali li m’għadux awtorizzat
1
ANNESS I
KARATTERISTIĊI TAL-PRODOTT FIL-QOSOR
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Nobilis Influenza H7N1 emulsjoni għal injezzjoni
2.
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
Doża ta’ 0.5ml fiha:
SUSTANZA ATTIVA:
Antiġen sħiħ inattivat tal-virus tal-influwenza avjarja, subtip
H7N1 (strejn,
A/CK/Italy/473/99), li jinduċi titru ta’ HI ta’ ≥6.0log
2
, kif ittestjat għat-test ta’ potenza.
ADJUVANT
Paraffina likwida ħafifa 234.8mg/0.5ml
Għal-lista sħiħa ta’ l-ingredjenti (mhux attivi), ara s-sezzjoni
6.1.
3.
GĦAMLA FARMAĊEWTIKA
Emulsjoni għal injezzjoni
4.
TAGĦRIF KLINIKU
4.1
SPEĊI LI FUQHOM SER JINTUŻA L-PRODOTT
Flieles u papri
4.2
INDIKAZZJONIJIET GĦAL UŻU TAL-PRODOTT LI JISPEĊIFIKAW L-ISPEĊI LI
FUQHOM SE JINTUŻA L-
PRODOTT.
Għal immunizzazzjoni attiva fil-flieles u l-papri kontra l-Influwenza
avjarja tip A, subtip
H7N1.
L-effikaċja kienet evalwata abbażi ta’riżultati preliminari
fil-flieles u papri .
Fil-flieles, tnaqqis ta’ sinjali kliniċi, mortalita u tneħħija
tal-virus wara tlaqqiegħ mal-vaċċin
ġew murija fi żmien ġimgħatejn wara t-tilqima waħda
Fil-papri, tnaqqis fit-tneħħija tal-virus ġew murija fi żmien
ġimgħatejn wara tilqima waħda
Għalkemm ma ġietx investigata b’din l-istrejn partikulari A1,
studji mwettqa bi strejns oħra
juru li
anti-korpi fis-sirum hu mistenni li jippersistu għal tal-anqas 12
–il xahar wara
amministrazzjoni ta’ żewg dożi tal-vaċċin. Iż-zmien ta’ kemm
iddum l-immunita fil-papri
mhix magħrufa.
4.3
KONTRA INDIKAZZJONIJIET
Xejn.
4.4
TWISSIJIET SPEĊJALI GĦAL KULL SPEĊI LI GĦALIHA HU INDIKAT
IL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
3
Din it-tilqima ġiet ittestjata għas-sigurta tagħha fil-flieles u
informazzjoni fuq is -sigurta fil-
papri hija biss sapportiva. Jekk tintuża fi speċi avjarji oħra,
kkunsidrati fil-periklu ta’
infezzjoni, l-użu tagħha f’dawn l-ispeċi għandu jsir
bil-
                                
                                Read the complete document

Similar products

Active ingredient antiġenu tal-virus tal-influwenza tat-tjur mhux attivat tas-sottotip H7N1 (tensjoni, A / CK / Italja / 473/99)

antiġenu tal-virus tal-influwenza tat-tjur mhux attivat tas-sottotip H7N1 (tensjoni, A / CK / Italja / 473/99)

ATC code QI01AA23

QI01AA23

Marketed by Intervet International BV

Intervet International BV

INN (International Name) adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-07-2010
Public Assessment Report Public Assessment Report Bulgarian 26-07-2010
Patient Information leaflet Patient Information leaflet Spanish 26-07-2010
Summary of Product characteristics Summary of Product characteristics Spanish 26-07-2010
Public Assessment Report Public Assessment Report Spanish 26-07-2010
Patient Information leaflet Patient Information leaflet Czech 26-07-2010
Summary of Product characteristics Summary of Product characteristics Czech 26-07-2010
Public Assessment Report Public Assessment Report Czech 26-07-2010
Patient Information leaflet Patient Information leaflet Danish 26-07-2010
Summary of Product characteristics Summary of Product characteristics Danish 26-07-2010
Public Assessment Report Public Assessment Report Danish 26-07-2010
Patient Information leaflet Patient Information leaflet German 26-07-2010
Summary of Product characteristics Summary of Product characteristics German 26-07-2010
Public Assessment Report Public Assessment Report German 26-07-2010
Patient Information leaflet Patient Information leaflet Estonian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Estonian 26-07-2010
Public Assessment Report Public Assessment Report Estonian 26-07-2010
Patient Information leaflet Patient Information leaflet Greek 26-07-2010
Summary of Product characteristics Summary of Product characteristics Greek 26-07-2010
Public Assessment Report Public Assessment Report Greek 26-07-2010
Patient Information leaflet Patient Information leaflet English 26-07-2010
Summary of Product characteristics Summary of Product characteristics English 26-07-2010
Public Assessment Report Public Assessment Report English 26-07-2010
Patient Information leaflet Patient Information leaflet French 26-07-2010
Summary of Product characteristics Summary of Product characteristics French 26-07-2010
Public Assessment Report Public Assessment Report French 26-07-2010
Patient Information leaflet Patient Information leaflet Italian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Italian 26-07-2010
Public Assessment Report Public Assessment Report Italian 26-07-2010
Patient Information leaflet Patient Information leaflet Latvian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Latvian 26-07-2010
Public Assessment Report Public Assessment Report Latvian 26-07-2010
Patient Information leaflet Patient Information leaflet Lithuanian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Lithuanian 26-07-2010
Public Assessment Report Public Assessment Report Lithuanian 26-07-2010
Patient Information leaflet Patient Information leaflet Hungarian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Hungarian 26-07-2010
Public Assessment Report Public Assessment Report Hungarian 26-07-2010
Patient Information leaflet Patient Information leaflet Dutch 26-07-2010
Summary of Product characteristics Summary of Product characteristics Dutch 26-07-2010
Public Assessment Report Public Assessment Report Dutch 26-07-2010
Patient Information leaflet Patient Information leaflet Polish 26-07-2010
Summary of Product characteristics Summary of Product characteristics Polish 26-07-2010
Public Assessment Report Public Assessment Report Polish 26-07-2010
Patient Information leaflet Patient Information leaflet Portuguese 26-07-2010
Summary of Product characteristics Summary of Product characteristics Portuguese 26-07-2010
Public Assessment Report Public Assessment Report Portuguese 26-07-2010
Patient Information leaflet Patient Information leaflet Romanian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Romanian 26-07-2010
Public Assessment Report Public Assessment Report Romanian 26-07-2010
Patient Information leaflet Patient Information leaflet Slovak 26-07-2010
Summary of Product characteristics Summary of Product characteristics Slovak 26-07-2010
Public Assessment Report Public Assessment Report Slovak 26-07-2010
Patient Information leaflet Patient Information leaflet Slovenian 26-07-2010
Summary of Product characteristics Summary of Product characteristics Slovenian 26-07-2010
Public Assessment Report Public Assessment Report Slovenian 26-07-2010
Patient Information leaflet Patient Information leaflet Finnish 26-07-2010
Summary of Product characteristics Summary of Product characteristics Finnish 26-07-2010
Public Assessment Report Public Assessment Report Finnish 26-07-2010
Patient Information leaflet Patient Information leaflet Swedish 26-07-2010
Summary of Product characteristics Summary of Product characteristics Swedish 26-07-2010
Public Assessment Report Public Assessment Report Swedish 26-07-2010

Search alerts related to this product

Alerts Nobilis Influenza H7N1 antiġenu tal-virus tal-influwenza tat-tjur adjuvanted inactivated vaccine against

Nobilis Influenza H7N1 antiġenu tal-virus tal-influwenza tat-tjur adjuvanted inactivated vaccine against

View documents history

Documents history Documents history

Nobilis Influenza H7N1