Incivo

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
06-10-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
06-10-2016
Public Assessment Report Public Assessment Report (PAR)
06-10-2016

Active ingredient:

telaprevir

Available from:

Janssen-Cilag International N.V.

ATC code:

J05AE

INN (International Name):

telaprevir

Therapeutic group:

Antivirali għal użu sistemiku

Therapeutic area:

Epatite Ċ, Kronika

Therapeutic indications:

Incivo, f'kombinazzjoni ma 'peginterferon alfa u ribavirin, huwa indikat għall-kura tal-ġenotip-1 epatite Ċ kronika f'pazjenti adulti b'mard kumpensat tal-fwied (inkluż ċirrożi):li huma trattament naïve;li jkunu diġà ġew ittrattati b'interferon alfa (pegylated jew mhux pegylated) waħdu jew f'kombinazzjoni ma' ribavirin, inkluż relapsers, dawk li wrew rispons parzjali u dawk li rrispondew null.

Product summary:

Revision: 19

Authorization status:

Irtirat

Authorization date:

2011-09-19

Patient Information leaflet

                                56
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
57
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
INCIVO 375 MG PILLOLI MIKSIJIN B’RITA
telaprevir
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 TIBDA TIEĦU DIN IL-MEDIĊINA
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.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib 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 INCIVO u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu INCIVO
3.
Kif għandek tieħu INCIVO
4.
Effetti sekondarji possibbli
5.
Kif taħżen INCIVO
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU INCIVO U GĦALXIEX JINTUŻA
INCIVO jaġixxi kontra l-virus li jikkawża l-infezzjoni tal-epatite
Ċ u jintuża biex jikkura l-infezzjoni
tal-epatite Ċ kronika f’pazjenti adulti (ta’ età ta’ bejn
18-il sena u 65 sena) flimkien ma’ peginterferon
alfa u ribavirin. INCIVO fih sustanza msejħa telaprevir u jagħmel
parti minn grupp ta’ mediċini
msejħa_‘impedituri ta’ protease NS3-4A’_. L-impedituri ta’
protease NS3-4A inaqqsu l-ammont tal-
virus tal-Epatite Ċ li jinsab fil-ġisem tiegħek. INCIVO
m’għandux jittieħed waħdu, u għandu jittieħed
flimkien ma’ peginterferon alfa u ribavirin sabiex il-kura tiegħek
t
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
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
INCIVO 375 mg pilloli miksijin b’rita.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b’rita fiha 375 mg ta’ telaprevir.
Eċċipjenti: 2.3 mg sodium f’kull pillola miksija b’rita.
Għal-lista kompluta ta’ sustanzi eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita.
Pilloli sofor forma ta’ kapsula b’tul ta’ madwar 20 mm,
immarkati b’“T375” fuq naħa waħda.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
INCIVO, flimkien ma’ peginterferon alfa u ribavirin, huwa indikat
għall-kura ta’ epatite Ċ kronika tal-
ġenotip 1 f’pazjenti adulti b’mard tal-fwied ikkumpensat (inkluż
ċirrożi):
-
li qatt ma ħadu kura qabel;
-
li qabel kienu kkurati b’interferon alfa (pegilat jew mhux pegilat)
waħdu jew flimkien ma’
ribavirin, inkluż dawk li jkunu rkadew, dawk li ma jkunux irrispondew
b’mod sħiħ u dawk li
ma jkunu rrispondew xejn għall-kura (ara sezzjonijiet 4.4 u 5.1).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Kura b’INCIVO għandha tinbeda u tiġi mmonitorjata minn tabib
b’esperjenza fl-immaniġġar ta’
epatite Ċ kronika.
Pożoloġija
INCIVO, 1,125 mg (tlett pilloli ta’ 375 mg miksijin b’rita)
għandhom jittieħdu mill-ħalq darbtejn
kuljum (b.i.d.) mal-ikel. Alternattivament, 750 mg (żewġ pilloli
ta’ 375 mg) jistgħu jittieħdu mill-ħalq
kull 8 sigħat (q8h) mal-ikel. Id-doża totali tal-kuljum hija ta’ 6
pilloli (2,250 mg). It-teħid ta’ INCIVO
mingħajr ikel jew mingħajr ma wieħed joqgħod attent
għall-intervall ta
                                
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Active ingredient telaprevir

telaprevir

ATC code J05AE

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Marketed by Janssen-Cilag International N.V.

Janssen-Cilag International N.V.

INN (International Name) telaprevir

telaprevir

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