ViraferonPeg

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
22-01-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
22-01-2021
Public Assessment Report Public Assessment Report (PAR)
22-01-2021

Active ingredient:

peginterferon alfa-2b

Available from:

Merck Sharp Dohme Ltd 

ATC code:

L03AB10

INN (International Name):

peginterferon alfa-2b

Therapeutic group:

Immunostimulanti,

Therapeutic area:

Epatite Ċ, Kronika

Therapeutic indications:

Adults (tritherapy)ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Jekk jogħġbok irreferi għall-ribavirin u boceprevir-sommarji tal-karatteristiċi tal-prodott (SmPCs) meta ViraferonPeg ikun ser jintuża flimkien ma ' dawn il-mediċini. Adults (bitherapy and monotherapy)ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. ViraferonPeg f'kombinazzjoni ma ' ribavirin (bitherapy) huwa indikat għall-kura ta CHC infezzjoni fil-pazjenti adulti li ma kienux trattati qabel inkluż pazjenti b'HIV klinikament stabbli ko-infezzjoni u f'pazjenti adulti li jkunu fallew it-trattament preċedenti bl-interferon-alpha (pegilata jew mhux pegilata) u terapija kombinata b'ribavirin jew monoterapija b'interferon alfa. Il-monoterapija b'Interferon, li tinkludi ViraferonPeg, tintuża l-aktar f'każ ta 'intolleranza jew ta' kontra-indikazzjoni għal ribavirin. Jekk jogħġbok irreferi għall-ribavirin SmPC meta ViraferonPeg ikun ser jintuża flimkien ma ' ribavirin. Paediatric population (bitherapy)ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA. Meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir li jista'jkun irriversibbli f'xi pazjenti. Id-deċiżjoni li l-kura għandha tittieħed każ b'każ. Jekk jogħġbok irreferi għall-ribavirin SmPC għal kapsuli jew soluzzjoni orali meta ViraferonPeg ikun ser jintuża flimkien ma ' ribavirin.

Product summary:

Revision: 36

Authorization status:

Irtirat

Authorization date:

2000-05-28

Patient Information leaflet

                                117
B. FULJETT TA’ TAGĦRIF
118
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
VIRAFERONPEG 50 MIKROGRAMMA TRAB U SOLVENT GĦAL SOLUZZJONI
GĦALL-INJEZZJONI
VIRAFERONPEG 80 MIKROGRAMMA TRAB U SOLVENT GĦAL SOLUZZJONI
GĦALL-INJEZZJONI
VIRAFERONPEG 100 MIKROGRAMMA TRAB U SOLVENT GĦAL SOLUZZJONI
GĦALL-INJEZZJONI
VIRAFERONPEG 120 MIKROGRAMMA TRAB U SOLVENT GĦAL SOLUZZJONI
GĦALL-INJEZZJONI
VIRAFERONPEG 150 MIKROGRAMMA TRAB U SOLVENT GĦAL SOLUZZJONI
GĦALL-INJEZZJONI
peginterferon alfa-2b
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA 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 ViraferonPeg u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża ViraferonPeg
3.
Kif għandek tuża ViraferonPeg
4.
Effetti sekondarji possibbli
5.
Kif taħżen ViraferonPeg
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU VIRAFERONPEG U GĦALXIEX JINTUŻA
Is-sustanza attiva f’din il-mediċina hija proteina li tissejjaħ
peginterferon alfa-2b, li tagħmel parti mill-
klassi ta’ mediċini li jissejħu interferons. Interferons huma
magħmula mis-sistema immuni ta’ ġismek
sabiex jgħinu jiġġieldu l-infezzjonijiet u mard serju. Din
il-mediċina tiġi injettata f’ġismek biex
taħdem mas-sistema immuni tiegħek. Din il-mediċina tintuża
fil-kura tal-epatite Ċ kronika, infezzjoni
virali tal-fwied.
Adulti
Il-kombinazzjoni ta’ din il-mediċina, ribavirin and boceprevir hija
rrakkomandata biex tintuża għal xi tipi
ta’ infezzjonijiet kroniċi bil
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
ViraferonPeg 50 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
ViraferonPeg 80 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
ViraferonPeg 100 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
ViraferonPeg 120 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
ViraferonPeg 150 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
ViraferonPeg 50 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
Kull kunjett fih 50 mikrogramma ta’ peginterferon alfa-2b hekk kif
imkejjel fuq bażi ta’ proteina.
Kull kunjett jipprovdi 50 mikrogramma/0,5 ml ta’ peginterferon
alfa-2b meta rikostitwit kif
irrakkomandat.
ViraferonPeg 80 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
Kull kunjett fih 80 mikrogramma ta’ peginterferon alfa-2b hekk kif
imkejjel fuq bażi ta’ proteina.
Kull kunjett jipprovdi 80 mikrogramma/0,5 ml ta’ peginterferon
alfa-2b meta rikostitwit kif
irrakkomandat.
ViraferonPeg 100 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
Kull kunjett fih 100 mikrogramma ta’ peginterferon alfa-2b hekk kif
imkejjel fuq bażi ta’ proteina.
Kull kunjett jipprovdi 100 mikrogramma/0,5 ml ta’ peginterferon
alfa-2b meta rikostitwit kif
irrakkomandat.
ViraferonPeg 120 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
Kull kunjett fih 120 mikrogramma ta’ peginterferon alfa-2b hekk kif
imkejjel fuq bażi ta’ proteina.
Kull kunjett jipprovdi 120 mikrogramma/0,5 ml ta’ peginterferon
alfa-2b meta rikostitwit kif
irrakkomandat.
ViraferonPeg 150 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
Kull kunjett fih 150 mikrogramma ta’ peginterferon alfa-2b hekk kif
imkejjel fuq bażi ta’ proteina.
Kull kunjett jipprovdi 150 mikrogramma/0,5 ml ta’ peginterferon
alfa-2b meta rikostitwit kif
irrakkomandat.
Is-sus
                                
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Similar products

Active ingredient peginterferon alfa-2b

peginterferon alfa-2b

ATC code L03AB10

L03AB10

Marketed by Merck Sharp Dohme Ltd 

Merck Sharp Dohme Ltd 

INN (International Name) peginterferon alfa-2b

peginterferon alfa-2b

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