Fluenz

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
03-12-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
03-12-2014
Public Assessment Report Public Assessment Report (PAR)
03-12-2014

Active ingredient:

Reassortant-virus tal-influwenza (ħaj attenwat) tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 bħal strejn, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain

Available from:

MedImmune LLC

ATC code:

J07BB03

INN (International Name):

influenza vaccine (live attenuated, nasal)

Therapeutic group:

Vaċċini

Therapeutic area:

Influenza, Human; Immunization

Therapeutic indications:

Profilassi ta 'l-influwenza f'individwi ta' 24 xahar sa inqas minn 18-il sena. L-użu ta Fluenz għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.

Product summary:

Revision: 4

Authorization status:

Irtirat

Authorization date:

2011-01-27

Patient Information leaflet

                                22
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
23
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
FLUENZ SPREJ GĦALL-IMNIEĦER, SUSPENSJONI
Tilqima kontra l-influwenza (ħajja attenwata, nażali)
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL MA TINGĦATA T-TILQIMA GĦAX FIH
INFORMAZZJONI IMPORTANTI
GĦALIK U GĦAT-TIFEL/TIFLA TIEGĦEK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-infermiera jew
lill-ispiżjar tiegħek.
-
Din it-tilqima ġiet mogħtija lilek jew lit-tifel/tifla tiegħek
biss. M’għandekx tgħaddiha
lil persuni oħra.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, l-infermier jew
lill-ispiżjar tiegħek.
Dan jinkludi xi effett sekondarju possibbli li m’huwiex elenkat
f’dan il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Fluenz u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tingħata Fluenz
3.
Kif għandu jingħata Fluenz
4.
Effetti sekondarji possibbli
5.
Kif taħżen Fluenz
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU FLUENZ U GĦALXIEX JINTUŻA
Fluenz hu til
qim
a għal prevenzjoni tal-influwenza. Jintuża fi tfal u adolexxenti li
jkollhom 24 xahar
sa inqas minn 18-il sena ta’ età.
Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta’
difiża naturali tal-ġisem) ser
tipproduċi l-protezzjoni tagħha stess kontra l-virus tal-influwenza.
L-ebda wieħed mill-ingredjenti
fit-tilqima ma jista’ jikkawża l-influwenza.
Hu magħruf li viruses tat-tilqima Fluenz jikbru fil-bajd
tat-tiġieġ. It-tilqima jattakka tliet razez ta’
viruses tal-influwenza kull sena, wara r-rakkomandazzjonijiet annwali
mill-O
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI T
AL-PRODOT
T
Prodott mediċinali li m’għadux awtorizzat
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti dwar il-kura tas-
saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa
suspettata.> Ara sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
FLUENZ sprej għall-imnieħer, suspensjoni
Tilqima kontra l-influwenza (ħajja attenwata, nażali)
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Virus tal-influwenza reassortant* (ħaj attenwat) tar-razez li
ġejjin**:
A/California/7/2009 razza qisha (H1N1)pdm09
(A/California/7/2009, MEDI 228029)
10
7.0±0.5
FFU***
A/Victoria/361/2011 razza qisha (H3N2)
(A/Texas/50/2012, MEDI 237514)
10
7.0±0.5
FFU***
B/Massachusetts/2/2012 razza qisha
(B/Massachusetts/2/2012, MEDI 237751)
10
7.0±0.5
FFU***
.......................................................................................................f’kull
doża ta’ 0.2 ml
*
ippropagat f’bajd fertilizzat tat-tiġieġ minn gruppi ta’
tiġieġ b’saħħithom.
**
magħmul f’ċelluli VERO permezz ta’ teknoloġija ġenetika
reverse. Dan il-prodott fih organiżmi
ġenetikament modifikati (GMOs).
***
unitajiet fokus fluworexxenti (fluorescent focus units)
Din it-tilqima hi konformi mar-rakkomandazzjoni tal-WHO (Emisferu
tat-Tramuntana) u d-deċiżjoni
tal-UE għall-istaġun 2013/2014.
It-tilqima jista’ jkun fiha residwi tas-sustanzi li ġejjin:
proteini tal-bajd (eż. ovalbumin) u gentamicin.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Sprej għall-imnieħer, suspensjoni
Is-suspensjoni hi bla kulur sa lewn isfar ċar, minn ċara sa
opalexxenti. Jista’ jkun hemm frak
żgħir abjad.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Profilassi tal-influwenza f’individwi minn età ta’ 24 xahar sa
inqas minn 18-il sena.
L-użu ta’ FLUENZ g
                                
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Similar products

Active ingredient Reassortant-virus tal-influwenza (ħaj attenwat) tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 bħal strejn, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain

Reassortant-virus tal-influwenza (ħaj attenwat) tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 bħal strejn, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain

ATC code J07BB03

J07BB03

Marketed by MedImmune LLC

MedImmune LLC

INN (International Name) influenza vaccine (live attenuated, nasal)

influenza vaccine (live attenuated, nasal)

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Fluenz