PegIntron

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

peginterferon alfa-2b

Available from:

Merck Sharp & Dohme B.V.

ATC code:

L03AB10

INN (International Name):

peginterferon alfa-2b

Therapeutic group:

Immunostimulants,

Therapeutic area:

Hepatitis C, Chronic

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.Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when PegIntron is to be used in combination with these medicines.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 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 PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.Please refer to the ribavirin SmPC when PegIntron is to be used in combination with 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.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 PegIntron is to be used in combination with ribavirin.

Product summary:

Revision: 36

Authorization status:

Withdrawn

Authorization date:

2000-05-24

Patient Information leaflet

112
B. PACKAGE LEAFLET
113
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEGINTRON 50 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGINTRON 80 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGINTRON 100 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGINTRON 120 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGINTRON 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 PegIntron is and what it is used for
2.
What you need to know before you use PegIntron
3.
How to use PegIntron
4.
Possible side effects
5.
How to store PegIntron
6.
Contents of the pack and other information
1.
WHAT PEGINTRON 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 interferons and pegylated interfer

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
PegIntron 50 micrograms powder and solvent for solution for injection
PegIntron 80 micrograms powder and solvent for solution for injection
PegIntron 100 micrograms powder and solvent for solution for injection
PegIntron 120 micrograms powder and solvent for solution for injection
PegIntron 150 micrograms powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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 same therapeutic class (see sect