Victrelis

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
31-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
31-07-2018
Public Assessment Report Public Assessment Report (PAR)
31-07-2018

Active ingredient:

Boceprevir

Available from:

Merck Sharp Dohme Ltd

ATC code:

J05AE

INN (International Name):

boceprevir

Therapeutic group:

Antivirali għal użu sistemiku

Therapeutic area:

Epatite Ċ, Kronika

Therapeutic indications:

Victrelis huwa indikat għall-kura ta ' l-infezzjoni tal-ġenotip-1 kronika epatite-C (CHC), flimkien mal-peginterferon alfa u ribavirin, fil-pazjenti adulti b ' mard tal-fwied kompensat li huma mhux ittrattat minn qabel jew li jkunu fallew terapija qabel.

Product summary:

Revision: 22

Authorization status:

Irtirat

Authorization date:

2011-07-18

Patient Information leaflet

                                51
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
52
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
VICTRELIS 200 MG KAPSULI IBSIN
boceprevir
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 Victrelis u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Victrelis
3.
Kif għandek tieħu Victrelis
4.
Effetti sekondarji possibbli
5.
Kif taħżen Victrelis
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU VICTRELIS U GĦALXIEX JINTUŻA
X’INHU VICTRELIS
Victrelis fih is-sustanza attiva msejħa boceprevir li tgħin biex
tikkumbatti l-infezzjoni tal-epatite Ċ
billi twaqqaf il-virus milli jimmultiplika. Victrelis għandu dejjem
jintuża flimkien ma’ żewġ mediċini
oħra. Dawn jissejħu peginterferon alfa u ribavirin. Victrelis
m’għandux jintuża waħdu.
GĦALXIEX JINTUŻA VICTRELIS
Victrelis, flimkien ma’ peginterferon alfa u ribavirin, jintuża
għall-infezzjoni kronika bil-virus tal-
epatite Ċ fl-adulti (msejħa wkoll infezzjoni b’HCV).
Victrelis jista’ jintuża f’adulti li qatt ma ħadu kura
għall-infezzjoni ta’ HCV jew li qabel użaw
mediċini imsejħa ‘interferons’ u ‘interferons pegilati’.
KIF JAĦDEM VICTRELIS
Victrelis jinibixxi r-replikazzjoni diretta tal-virus u b’dan il-mod
jikkontribwixxi biex ibaxxi l-
ammont ta’ virus tal-epatite Ċ fil-ġisem tiegħek.
2.
X’GĦANDEK TKUN TAF QABEL MA TIEĦU VICTRELIS
TIĦUX VICTRELI
                                
                                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
Victrelis 200 mg kapsuli ibsin
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull kapsula iebsa fiha 200 mg ta’ boceprevir.
Eċċipjent b’effett magħruf
Kull kapsula fiha 56 mg ta’ lactose monohydrate.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Kapsula iebsa.
Kull kapsula għadha għatu kannella jagħti fl-isfar, opak bil-lowgo
"MSD" stampat b’linka ħamra u
korp ofwajt, opak bil-kodiċi "314" stampat b’linka ħamra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Victrelis huwa indikat għall-kura ta’ infezzjoni kronika bl-epatite
Ċ (CHC) tal-ġenotip 1, flimkien ma’
peginterferon alfa u ribavirin, f’pazjenti adulti b’mard kumpensat
tal-fwied li ma kienux ħadu kura
qabel jew li t-terapija li ħadu qabel ma kienitx ħadmet fuqhom (ara
sezzjonijiet 4.4 u 5.1).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Kura b’Victrelis għandha tinbeda u tiġi ssorveljata minn tabib
b’esperjenza fl-immaniġġar ta’ epatite
Ċ kronika.
Pożoloġija
Victrelis għandu jingħata flimkien ma’ peginterferon alfa u
ribavirin. Is-Sommarju tal-Karatteristiċi
tal-Prodott ta’ peginterferon alfa u ribavirin (PR) għandu jiġi
kkonsultat qabel ma tinbeda terapija
b’Victrelis.
Id-doża rrakomandata ta’ Victrelis hija ta’ 800 mg mogħtija
mill-ħalq tliet darbiet kuljum (TID)
mal-ikel (ikla jew ikla ħafifa). L-akbar doża ta’ Victrelis li
tista’ tingħata kuljum hija 2,400 mg. Għoti
mingħajr ikel jista’ jkun assoċjat ma’ telf tal-effikaċja
minħabba esponiment inqas minn dak ideali.
_Pazjenti mingħajr ċirrożi li ma kienux ħadu kura qabel jew li ma
ħadmitx fuqhom terapija li ħadu_
_qabel_
Ir-rakkomandazzjonijiet ta’ dożaġġ li ġejjin huma differenti
għal xi sottogruppi mid-dożaġġi li ġew
studjati fil-provi ta’ Fażi 3 (ara sezzjoni 5.1).
Prodott mediċinali li m’għadux awtorizzat
3
Tabella 1
Tul 
                                
                                Read the complete document

Similar products

Active ingredient Boceprevir

Boceprevir

ATC code J05AE

J05AE

Marketed by Merck Sharp Dohme Ltd

Merck Sharp Dohme Ltd

INN (International Name) boceprevir

boceprevir

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 31-07-2018
Public Assessment Report Public Assessment Report Bulgarian 31-07-2018
Patient Information leaflet Patient Information leaflet Spanish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 31-07-2018
Public Assessment Report Public Assessment Report Spanish 31-07-2018
Patient Information leaflet Patient Information leaflet Czech 31-07-2018
Summary of Product characteristics Summary of Product characteristics Czech 31-07-2018
Public Assessment Report Public Assessment Report Czech 31-07-2018
Patient Information leaflet Patient Information leaflet Danish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Danish 31-07-2018
Public Assessment Report Public Assessment Report Danish 31-07-2018
Patient Information leaflet Patient Information leaflet German 31-07-2018
Summary of Product characteristics Summary of Product characteristics German 31-07-2018
Public Assessment Report Public Assessment Report German 31-07-2018
Patient Information leaflet Patient Information leaflet Estonian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Estonian 31-07-2018
Public Assessment Report Public Assessment Report Estonian 31-07-2018
Patient Information leaflet Patient Information leaflet Greek 31-07-2018
Summary of Product characteristics Summary of Product characteristics Greek 31-07-2018
Public Assessment Report Public Assessment Report Greek 31-07-2018
Patient Information leaflet Patient Information leaflet English 31-07-2018
Summary of Product characteristics Summary of Product characteristics English 31-07-2018
Public Assessment Report Public Assessment Report English 31-07-2018
Patient Information leaflet Patient Information leaflet French 31-07-2018
Summary of Product characteristics Summary of Product characteristics French 31-07-2018
Public Assessment Report Public Assessment Report French 31-07-2018
Patient Information leaflet Patient Information leaflet Italian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Italian 31-07-2018
Public Assessment Report Public Assessment Report Italian 31-07-2018
Patient Information leaflet Patient Information leaflet Latvian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Latvian 31-07-2018
Public Assessment Report Public Assessment Report Latvian 31-07-2018
Patient Information leaflet Patient Information leaflet Lithuanian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Lithuanian 31-07-2018
Public Assessment Report Public Assessment Report Lithuanian 31-07-2018
Patient Information leaflet Patient Information leaflet Hungarian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Hungarian 31-07-2018
Public Assessment Report Public Assessment Report Hungarian 31-07-2018
Patient Information leaflet Patient Information leaflet Dutch 31-07-2018
Summary of Product characteristics Summary of Product characteristics Dutch 31-07-2018
Public Assessment Report Public Assessment Report Dutch 31-07-2018
Patient Information leaflet Patient Information leaflet Polish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Polish 31-07-2018
Public Assessment Report Public Assessment Report Polish 31-07-2018
Patient Information leaflet Patient Information leaflet Portuguese 31-07-2018
Summary of Product characteristics Summary of Product characteristics Portuguese 31-07-2018
Public Assessment Report Public Assessment Report Portuguese 31-07-2018
Patient Information leaflet Patient Information leaflet Romanian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Romanian 31-07-2018
Public Assessment Report Public Assessment Report Romanian 31-07-2018
Patient Information leaflet Patient Information leaflet Slovak 31-07-2018
Summary of Product characteristics Summary of Product characteristics Slovak 31-07-2018
Public Assessment Report Public Assessment Report Slovak 31-07-2018
Patient Information leaflet Patient Information leaflet Slovenian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Slovenian 31-07-2018
Public Assessment Report Public Assessment Report Slovenian 31-07-2018
Patient Information leaflet Patient Information leaflet Finnish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Finnish 31-07-2018
Public Assessment Report Public Assessment Report Finnish 31-07-2018
Patient Information leaflet Patient Information leaflet Swedish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Swedish 31-07-2018
Public Assessment Report Public Assessment Report Swedish 31-07-2018
Patient Information leaflet Patient Information leaflet Norwegian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Norwegian 31-07-2018
Patient Information leaflet Patient Information leaflet Icelandic 31-07-2018
Summary of Product characteristics Summary of Product characteristics Icelandic 31-07-2018
Patient Information leaflet Patient Information leaflet Croatian 31-07-2018
Summary of Product characteristics Summary of Product characteristics Croatian 31-07-2018

Search alerts related to this product

Alerts Victrelis Boceprevir

Victrelis Boceprevir

View documents history

Documents history Documents history

Victrelis