Optaflu

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-02-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
13-02-2017
Public Assessment Report Public Assessment Report (PAR)
02-12-2015

Active ingredient:

virus tal-influwenza antiġeni tal-wiċċ (haemagglutinin u neuraminidase), inattivati, tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, tat-tip selvaġġ)A/Svizzera/9715293/2013 (H3N2) like strain(A/Nofsinhar l-Awstralja/55/2014, tat-tip selvaġġ)B/kulħadd jinstemgħu/3073/2013–like strain(B/Utah/9/2014, tat-tip selvaġġ)

Available from:

Seqirus GmbH

ATC code:

J07BB02

INN (International Name):

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Therapeutic group:

Vaċċini

Therapeutic area:

Influenza, Human; Immunization

Therapeutic indications:

Profilassi tal-influwenza għall-adulti, speċjalment f'dawk li għandhom riskju ogħla ta 'kumplikazzjonijiet assoċjati. Optaflu m'għandu jintuża skont il-gwida uffiċjali.

Product summary:

Revision: 16

Authorization status:

Irtirat

Authorization date:

2007-06-01

Patient Information leaflet

                                25
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
26
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
OPTAFLU SUSPENSJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA GĦAL-LEST
Tilqima ta’ l-influwenza (antiġen tal-wiċċ, inattivata,
ippreparata f’kulturi taċ-ċelluli)
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIEĦU DIN IT-TILQIMA PERESS LI
FIH INFORMAZZJONI IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar
jew lill-infermier tiegħek.
Dan jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Optaflu u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tirċievi Optaflu
3.
Kif jingħata Optaflu
4.
Effetti sekondarji possibbli
5.
Kif taħżen Optaflu
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU OPTAFLU U GЋALXIEX JINTUŻA
Optaflu hu tilqima kontra l-influwenza. Minħabba t-tip ta’
manifattura, Optaflu hu ħieles mill-proteina
tat-tiġieġ/bajd.
Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta’
difiża naturali tal-ġisem) tipproduċi
l-protezzjoni tagħha stess kontra l-virus t
al-influwenza. L-ebda sustanza fit-tilqima ma tista' tikkawża
l-influwenza.
Optaflu jintuża għall-prevenzjoni ta’ l-influwenza fl-adulti,
speċjalment f’dawk li jkollhom riskju
akbar ta’ komplikazzjonijiet assoċjati f’każ li jimirdu
bl-influwenza.
It-tilqima għandha fil-mira tagħha tliet razez tal-virus
tal-influwenza wara r-rakkomandazzjonijiet
mill-Organizzazzjoni Dinjija tas-Saħħa għall-istaġun 2015/2016.
2.
X’GĦANDEK TKUN TAF QABEL MA TIRĊIEVI OPTAFLU
M’GĦANDEKX TIRĊIEVI OPTAFLU

jekk inti allerġiku għat-tilqima ta’ l-influwenza jew għal xi
sustanza oħra ta’ din it-tilqima
(elenkati fis-sezzjoni 6)

jekk ikollok infezzjoni akuta.
TWISSIJIET U PREKAWZJONIJIET
Kellem 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
OPTAFLU
suspensjoni għall-injezzjoni f’siringa mimlija għal-lest
Tilqima ta’ l-influwenza (antiġen tal-wiċċ, inattivata,
ippreparata f’kolturi taċ-ċelluli)
(Staġun 2015/2016)
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Antiġeni tal-wiċċ tal-virus ta’ l-influwenza (haemagglutinin u
neuraminidase)*, inattivati, tar-razez
li ġejjin:
A/California/7/2009 (H1N1)pdm09 - razza simili
(A/Brisbane/10/2010, wild type)
15-il mikrogramma HA**
A/Switzerland/9715293/2013 (H3N2) - razza simili
(A/South Australia/55/2014, wild type)
15-il mikrogramma HA**
B/Phuket/3073/2013 - razza simili
(B/Utah/9/2014, wild type)
15-il mikrogramma HA**
f’kull doża ta’ 0.5 ml
.........................................................................
*
ippropagati fiċ-ċelluli Madin Darby Canine Kidney (MDCK)
**
haemagglutinin
It-tilqima hi konformi mar-rakkomandazzjoni tal-WHO (emisferu
tat-tramuntana) u mad-deċiżjoni ta’
l-UE għall-istaġun 2015/2016.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Suspensjoni għall-injezzjoni f’siringa mimlija għal-lest.
Ta’ kulur minn ċar sa ftit opalexxenti.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Profilassi ta’ l-influwenza għall-adulti, speċjalment f’dawk li
jkollhom riskju akbar ta’
komplikazzjonijiet assoċjati.
Optaflu għan
du jintuża skont il-gwida Uffiċjali.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Adulti minn 18-il sena:
Doża waħda ta’ 0.5 ml
Prodott mediċinali li m’għadux awtorizzat
3
_Popolazzjoni pedjatrika _
Is-sigurtà u l-effikaċja ta’ Optaflu fit-tfal u fl-adoloxxenti li
għandhom anqas minn 18-il sena għadhom
ma ġewx stabbiliti. Dejta mhux disponibbli. Għalhekk, Optaflu
mhuwiex rakkomandat għall-użu
fit-tfal u fl-adoloxxenti li għandhom inqas minn 18-il sena
(ara sezzjoni 5.1).
Metodu ta’ kif għandu jingħata
L-immunizzazzjoni
                                
                                Read the complete document

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Active ingredient virus tal-influwenza antiġeni tal-wiċċ (haemagglutinin u neuraminidase), inattivati, tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, tat-tip selvaġġ)A/Svizzera/9715293/2013 (H3N2) like strain(A/Nofsinhar l-Awstralja/55/2014, tat-tip selvaġġ)B/kulħadd jinstemgħu/3073/2013–like strain(B/Utah/9/2014, tat-tip selvaġġ)

virus tal-influwenza antiġeni tal-wiċċ (haemagglutinin u neuraminidase), inattivati, tar-razez li ġejjin:/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, tat-tip selvaġġ)A/Svizzera/9715293/2013 (H3N2) like strain(A/Nofsinhar l-Awstralja/55/2014, tat-tip selvaġġ)B/kulħadd jinstemgħu/3073/2013–like strain(B/Utah/9/2014, tat-tip selvaġġ)

ATC code J07BB02

J07BB02

Marketed by Seqirus GmbH

Seqirus GmbH

INN (International Name) influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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Summary of Product characteristics Summary of Product characteristics Bulgarian 13-02-2017
Public Assessment Report Public Assessment Report Bulgarian 02-12-2015
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Summary of Product characteristics Summary of Product characteristics Spanish 13-02-2017
Public Assessment Report Public Assessment Report Spanish 02-12-2015
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