IntronA
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
14-12-2022
Charakterystyka produktu
(SPC)
14-12-2022
Sprawozdanie z oceny publicznego
(PAR)
14-12-2022
Składnik aktywny:
interferon alfa-2b
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
L03AB05
INN (International Nazwa):
interferon alfa-2b
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Wskazania:
Chronic hepatitis BTreatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis.Chronic hepatitis CBefore initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon.Adult patientsIntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA).The best way to use IntronA in this indication is in combination with ribavirin.Children three years of age and older and adolescentsIntronA 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, not previously treated, 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 resulted in reduced final adult height in some patients.The decision to treat should be made on a case-by-case basis.Hairy-cell leukaemiaTreatment of patients with hairy cell leukaemia.Chronic myelogenous leukaemiaMonotherapyTreatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ≥ 34 %, but < 90 % Ph+ cells in the marrow.Combination therapyThe combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.Multiple myelomaAs maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.Follicular lymphomaTreatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.Carcinoid tumourTreatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.Malignant melanomaAs adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.
Podsumowanie produktu:
Revision: 34
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-03-09
Ulotka dla pacjenta
143
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
144
PACKAGE LEAFLET: INFORMATION FOR THE USER
INTRONA 3
MILLION IU/0.5
ML SOLUTION FOR INJECTION OR INFUSION
i
nterferon 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, 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 IntronA
is and what it is used for
2.
What you need to know before you use IntronA
3.
How to use IntronA
4.
Possible side effects
5.
How to store IntronA
6.
Contents of the pack and other
information
1.
WHAT INTRONA IS AND WHAT IT IS USED FOR
IntronA (interferon alfa
-
2b) modifies the response of the body's immune system to help fight
infections
and severe diseases.
IntronA is used in adult patients to treat certain disorders that
affec
t the blood, bone marrow, lymph
glands, or skin and may extend into the body. Included are hairy cell
leukaemia, chronic myelogenous
leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour,
and malignant melanoma.
IntronA is also used in adult
patients for the treatment of chronic hepatitis B or C, which are
viral
infections of the liver.
IntronA is used in combination with ribavirin in children 3 years of
age and older and adolescents who
have previously untreated chronic hepatitis C.
2.
WH
AT YOU NEED TO KNOW BEFORE YOU USE INTRONA
DO NOT USE INTRONA
-
if you are allergic to interferon or any of the other ingredients of
this medicine (listed in
section 6).
-
if you
have severe heart disease.
-
if you have poor kidney or liver function.
-
if you
have advanced decompensated (uncontrolled) liver disease.
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
IntronA 3 million IU/0.5
mL solution for injection or infusion
2.
QUALITATIVE
AND QUANTITATIVE COMPOSITION
One vial of solution for injection or infusion contains 3
million
IU of recombinant interferon alfa
-2b
produced in
E. coli
by recombinant DNA technology,
in 0.5
mL of solution.
For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic hepatitis B
Treatment of adult patients with chronic hepatitis B associated with
evide
nce of hepatitis B viral
replication (presence of DNA of hepatitis B virus
(HBV-
DNA) and hepatitis B antigen (HBeAg),
elevated alanine aminotransferase (ALT) and histologically proven
active liver inflammation and/or
fibrosis.
Chronic hepatitis C
Before
initiating treatment with IntronA, consideration should be given to
the results from clinical
trials comparing IntronA with pegylated interferon (see section
5.1).
Adult patients
IntronA is indicated for the treatment of adult patients with chronic
hepati
tis C who have elevated
transaminases without liver decompensation and who are positive for
hepatitis C virus RNA
(HCV-
RNA) (see section
4.4).
The best way to use IntronA in this indication is in combination with
ribavirin.
Children 3 years of age and ol
der and adolescents
IntronA is indicated, in a combination regimen with ribavirin, for the
treatment of children 3
years of
age and older and adolescents, who have chronic hepatitis C, not
previously treated, without liver
decompensation, and who are posit
ive 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 resulted in reduced final
adult height in some patients.
The decision to treat should be mad
e on a case by case basis (see section
4.4).
Hairy cell leukaemia
Treatment of
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