Pandemic Influenza Vaccine H5N1 Baxter AG

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-09-2023
Public Assessment Report Public Assessment Report (PAR)
13-09-2023

Active ingredient:

influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: A/Vjetnam/1203/2004 (H5N1)

Available from:

Resilience Biomanufacturing Ireland Limited

ATC code:

J07BB01

INN (International Name):

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

Therapeutic group:

Vaċċini

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. Il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.

Product summary:

Revision: 8

Authorization status:

Irtirat

Authorization date:

2009-10-16

Patient Information leaflet

                                39
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
40
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
SUSPENSJONI GĦALL-INJEZZJONI.
VAĊĊIN KONTRA L-INFLUWENZA PANDEMIKA (H5N1) (VIRIJON SĦIĦ,
INATTIVAT, IPPREPARAT F’KOLTURA
TAĊ-ĊELLULI)
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIĠI MLAQQAM PERESS LI FIH
INFORMAZZJONI IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu PANDEMIC INFLUENZA VACCINE H5N1 BAXTER u għal xiex jintuża
2.
X’għandek tkun taf qabel tiġi mlaqqam b’PANDEMIC INFLUENZA
VACCINE
H5N1 BAXTER
3.
Kif jingħata PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
4.
Effetti sekondarji possibbli
5.
Kif taħżen PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU PANDEMIC INFLUENZA VACCINE H5N1 BAXTER U GĦALXIEX JINTUŻA
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER huwa vaċċin użat f’persuni
ta’ età minn sitt
xhur ’il fuq. Jintuża biex jipprevjeni l-influwenza f’pandemija
li tkun ġiet iddikjarata uffiċjalment.
L-influwenza pandemika hi tip ta’ influwenza li sseħħ kull ftit
għexieren ta’ snin u li tinfirex malajr
u taffettwa l-biċċa l-kbira tal-pajjiżi u reġjuni madwar id-dinja.
Is-sintomi (sinjali) tal-influwenza
pandemika huma bħal dawk ta’ influwenza ‘ordinarja’ iżda
normalment ikunu iktar severi.
Il-vaċċin jaħdem billi jgħin lill-ġisem jipproduċi l-protezzjoni
(antikorpi) tiegħu stess kontra l-marda.
2.
X'GĦANDEK TKUN TAF QABEL TIĠI MLAQQAM B’PANDEMIC INFLUENZA VACCINE
H5N1 BAXTER
TUŻAX PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
•
jekk qabel kellek reazzjoni allerġika serja (jiġifieri ta’
theddida għall-ħajja) għal PANDEMIC
INF
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Suspensjoni għall-injezzjoni
Vaċċin kontra l-influwenza pandemika (H5N1) (virijon sħiħ,
inattivat, ippreparat f’koltura taċ-ċelluli)
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Vaċċin kontra l-influwenza (virijon sħiħ, inattivat) li fih
antiġen* ta’:
A/Vjetnam/1203/2004 (H5N1)
7.5 mikrogrammi**
għal kull doża ta’ 0.5 ml
*
prodott f’ċelluli Vero
**
emaglutinin
Din it-tilqima tikkonforma mar-rakkomandazzjoni tal-WHO u
mad-deċiżjoni tal-UE għall-pandemija.
It-tilqima hi disponibbli f’reċipjent ta’ aktar minn doża waħda
(ara sezzjoni 6.5 għan-numru ta’ dożi
f’kull kunjett).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Suspensjoni għall-injezzjoni.
Il-vaċċin huwa suspensjoni ta’ lewn ofwajt, opalexxenti u
transluċidu.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Profilassi tal-influwenza f’sitwazzjoni pandemika ddikjarata b’mod
uffiċjali. Il-vaċċin kontra
l-influwenza pandemika għandu jintuża skont il-gwida uffiċjali.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
_Adulti u tfal minn 6 xhur ’l fuq:_
Doża waħda ta’ 0.5 ml f’data magħżula.
Għandha tingħata doża oħra tal-vaċċin wara intervall ta’
mill-anqas 3 ġimgħat.
Metodu ta’ kif għandu jingħata
L-immunizzazzjoni għandha ssir permezz ta’ injezzjoni ġol-muskoli
fil-muskolu deltojde jew
fil-koxxa anterolaterali, skont il-massa tal-muskoli.
Għal aktar informazzjoni, ara sezzjoni 5.1.
4.3
KONTRAINDIKAZZJONIJIET
Storja ta’ reazzjoni anafilattika (jiġifieri ta’ theddida
għall-ħajja) għas-sustanza attiva jew għal
kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew
għal residwi fi traċċa (eż.
formaldehyde, benzonase, sucrose) ta’ dan il-vaċċin. Madankollu,
f’sitwazzjoni pandemika, jista’ jkun
Prodott mediċinali li m’għadux aw
                                
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Similar products

Active ingredient influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: A/Vjetnam/1203/2004 (H5N1)

influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: A/Vjetnam/1203/2004 (H5N1)

ATC code J07BB01

J07BB01

Marketed by Resilience Biomanufacturing Ireland Limited

Resilience Biomanufacturing Ireland Limited

INN (International Name) pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

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