Pegasys

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

peginterferon alfa-2a

Διαθέσιμο από:

pharmaand GmbH

Φαρμακολογική κατηγορία (ATC):

L03AB11

INN (Διεθνής Όνομα):

peginterferon alfa-2a

Θεραπευτική ομάδα:

Immunostimulants,

Θεραπευτική περιοχή:

Hepatitis C, Chronic; Hepatitis B, Chronic

Θεραπευτικές ενδείξεις:

Chronic hepatitis B Adult patients Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). Paediatric patients 3 years of age and older Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. Chronic hepatitis C Adult patients Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1. Paediatric patients 5 years of age and older Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).,

Περίληψη προϊόντος:

Revision: 46

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2002-06-20

Φύλλο οδηγιών χρήσης

106
B. PACKAGE LEAFLET
107
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEGASYS 180 MICROGRAMS SOLUTION FOR INJECTION
peginterferon alfa-2a
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, pharmacist or
nurse.
●
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pegasys is and what it is used for
2.
What you need to know before you use Pegasys
3.
How to use Pegasys
4.
Possible side effects
5.
How to store Pegasys
6.
Contents of the pack and other information
1.
WHAT PEGASYS IS AND WHAT IT IS USED FOR
Pegasys contains the active substance peginterferon alfa-2a, which is
a long-acting interferon.
Interferon is a protein that modifies the response of the body's
immune system to help fight infections
and severe diseases. Pegasys is used to treat chronic hepatitis B or
chronic hepatitis C in adults. It is
also used to treat chronic hepatitis B in children and adolescents
aged 3 years and older and chronic
hepatitis C in children and adolescents aged 5 years and older, who
have not been treated before. Both
chronic hepatitis B and C are viral infections of the liver.
CHRONIC HEPATITIS B:
Pegasys is usually used alone.
CHRONIC HEPATITIS C:
Pegasys is used in combination with other medicines, for the treatment
of
chronic hepatitis C (CHC).
Refer also to the package leaflets of any other medicines that are
used in combination with Pegasys.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PEGASYS
DO NOT USE PEGASYS
●
if you are allergic to peginterferon alfa-2a, to any interferon or any
of the other ingredients of
this medicine (listed in section 6).
●
if you have e

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pegasys 180 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pegasys 180 micrograms solution for injection
Each vial of 1 ml solution contains 180 micrograms peginterferon
alfa-2a*.
The strength indicates the quantity of the interferon alfa-2a moiety
of peginterferon alfa-2a without
consideration of the pegylation.
*The active substance, peginterferon alfa-2a, is a covalent conjugate
of the protein interferon alfa-2a
produced by recombinant DNA technology in
_Escherichia coli _
with bis-[monomethoxy polyethylene
glycol].
The potency of this medicinal product should not be compared to the
one of another pegylated or non-
pegylated protein of the same therapeutic class. For more information,
see section 5.1.
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear and colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic hepatitis B
_Adult patients _
Pegasys is indicated for the treatment of hepatitis B envelope antigen
(HBeAg)-positive or HBeAg-
negative chronic hepatitis B (CHB) in adult patients with compensated
liver disease and evidence of
viral replication, increased alanine aminotransferase (ALT) and
histologically verified liver
inflammation and/or fibrosis (see sections 4.4 and 5.1).
_Paediatric patients 3 years of age and older_
Pegasys is indicated for the treatment of HBeAg-positive CHB in
non-cirrhotic children and
adolescents 3 years of age and older with evidence of viral
replication and persistently elevated serum
ALT levels. With respect to the decision to initiate treatment in
paediatric patients see sections 4.2, 4.4
and 5.1.
3
Chronic hepatitis C
_Adult patients _
Pegasys is indicated in combination with other medicinal products, for
the treatment of chronic
hepatitis C (CHC) in patients with compensated liver disease (see
se