ViraferonPeg
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
22-01-2021
Fachinformation
(SPC)
22-01-2021
Öffentlichen Beurteilungsberichts
(PAR)
22-01-2021
Wirkstoff:
peginterferon alfa-2b
Verfügbar ab:
Merck Sharp Dohme Ltd
ATC-Code:
L03AB10
INN (Internationale Bezeichnung):
peginterferon alfa-2b
Therapiegruppe:
Immunostimulants,
Therapiebereich:
Hepatitis C, Chronic
Anwendungsgebiete:
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.Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines.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 in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with 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.When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis.Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
Produktbesonderheiten:
Revision: 36
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2000-05-28
Gebrauchsinformation
114
B. PACKAGE LEAFLET
115
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAFERONPEG 50 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
VIRAFERONPEG 80 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
VIRAFERONPEG 100 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
VIRAFERONPEG 120 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
VIRAFERONPEG 150 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
peginterferon alfa-2b
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ViraferonPeg is and what it is used for
2.
What you need to know before you use ViraferonPeg
3.
How to use ViraferonPeg
4.
Possible side effects
5.
How to store ViraferonPeg
6.
Contents of the pack and other information
1.
WHAT VIRAFERONPEG IS AND WHAT IT IS USED FOR
The active substance in this medicine is a protein called
peginterferon alfa-2b, which belongs to the
class of medicines called interferons. Interferons are made by your
body’s immune system to help
fight infections and severe diseases. This medicine is injected into
your body to work with your
immune system. This medicine is used for the treatment of chronic
hepatitis C, a viral infection of the
liver.
Adults
The combination of this medicine, ribavirin and boceprevir is
recommended for use for some types of
chronic hepatitis C virus infection (also called HCV infection) in
adults 18 years of age and older. It may
be used in adults who have not been previously treated for HCV
infection or who have previously used
medicines called inte
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ViraferonPeg 50 micrograms powder and solvent for solution for
injection
ViraferonPeg 80 micrograms powder and solvent for solution for
injection
ViraferonPeg 100 micrograms powder and solvent for solution for
injection
ViraferonPeg 120 micrograms powder and solvent for solution for
injection
ViraferonPeg 150 micrograms powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ViraferonPeg 50 micrograms powder and solvent for solution for
injection
Each vial contains 50 micrograms of peginterferon alfa-2b as measured
on a protein basis.
Each vial provides 50 micrograms/0.5 ml of peginterferon alfa-2b when
reconstituted as recommended.
ViraferonPeg 80 micrograms powder and solvent for solution for
injection
Each vial contains 80 micrograms of peginterferon alfa-2b as measured
on a protein basis.
Each vial provides 80 micrograms/0.5 ml of peginterferon alfa-2b when
reconstituted as recommended.
ViraferonPeg 100 micrograms powder and solvent for solution for
injection
Each vial contains 100 micrograms of peginterferon alfa-2b as measured
on a protein basis.
Each vial provides 100 micrograms/0.5 ml of peginterferon alfa-2b when
reconstituted as recommended.
ViraferonPeg 120 micrograms powder and solvent for solution for
injection
Each vial contains 120 micrograms of peginterferon alfa-2b as measured
on a protein basis.
Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when
reconstituted as recommended.
ViraferonPeg 150 micrograms powder and solvent for solution for
injection
Each vial contains 150 micrograms of peginterferon alfa-2b as measured
on a protein basis.
Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when
reconstituted as recommended.
The active substance is a covalent conjugate of recombinant interferon
alfa-2b* with monomethoxy
polyethylene glycol. The potency of this product should not be
compared to that of another pegylated
or non-pegylated protein of the sa
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