PegIntron

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
03-06-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-06-2021
Public Assessment Report Public Assessment Report (PAR)
03-06-2021

Active ingredient:

peginterferon alfa-2b

Available from:

Merck Sharp & Dohme B.V.

ATC code:

L03AB10

INN (International Name):

peginterferon alfa-2b

Therapeutic group:

Immunostimulanti,

Therapeutic area:

Epatite Ċ, Kronika

Therapeutic indications:

Adults (tritherapy)PegIntron 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 PegIntron ikun ser jintuża flimkien ma ' dawn il-mediċini. Adults (bitherapy and monotherapy)PegIntron 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. PegIntron 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 ma' interferon-alpha monoterapija. Il-monoterapija b'Interferon, li tinkludi PegIntron, tintuża l-aktar f'każ ta 'intolleranza jew ta' kontra-indikazzjoni għal ribavirin. Jekk jogħġbok irreferi għall-ribavirin SmPC meta PegIntron ikun ser jintuża flimkien ma ' ribavirin. Paediatric population (bitherapy)PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, 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 PegIntron ikun ser jintuża flimkien ma ' ribavirin.

Product summary:

Revision: 36

Authorization status:

Irtirat

Authorization date:

2000-05-24

Patient Information leaflet

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
PegIntron 50 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 80 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 100 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 120 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 150 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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
irrak
                                
                                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
PegIntron 50 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 80 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 100 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 120 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
PegIntron 150 mikrogramma ta’ trab u solvent għal soluzzjoni
għall-injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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
irrak
                                
                                Read the complete document

Similar products

Active ingredient peginterferon alfa-2b

peginterferon alfa-2b

ATC code L03AB10

L03AB10

Marketed by Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (International Name) peginterferon alfa-2b

peginterferon alfa-2b

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