Viraferon
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-05-2008
Charakterystyka produktu
(SPC)
27-05-2008
Sprawozdanie z oceny publicznego
(PAR)
27-05-2008
Składnik aktywny:
interferon alfa-2b
Dostępny od:
Schering-Plough Europe
Kod ATC:
L03AB05
INN (International Nazwa):
interferon alfa-2b
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Hepatitis C, Chronic; Hepatitis B, Chronic
Wskazania:
Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.Chronic Hepatitis C:Adult patients:IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).The best way to use IntronA in this indication is in combination with ribavirin.Chidren and adolescents:IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Podsumowanie produktu:
Revision: 11
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-03-09
Ulotka dla pacjenta
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Viraferon 1 million IU/ml powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 1 million IU of interferon alfa-2b
produced in _E.coli_ by recombinant DNA
technology.
After reconstitution, 1 ml contains 1 million IU of interferon
alfa-2b.
_ _
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
_ _
White to cream coloured powder.
Clear and colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic Hepatitis B
: Treatment of adult patients with chronic hepatitis B associated with
evidence of hepatitis B
viral replication (presence of HBV-DNA and HBeAg), elevated alanine
aminotransferase (ALT) and
histologically proven active liver inflammation and/or fibrosis.
Chronic Hepatitis C:
_Adult patients: _
Viraferon is indicated for the treatment of adult patients with
chronic hepatitis C who have elevated
transaminases without liver decompensation and who are positive for
serum HCV-RNA or anti-HCV (see
section 4.4).
The best way to use Viraferon in this indication is in combination
with ribavirin.
_Chidren and adolescents: _
Viraferon is intended for use, in a combination regimen with
ribavirin, for the treatment of children and
adolescents 3 years of age and older, who have chronic hepatitis C,
not previously treated, without liver
decompensation, and who are positive for serum HCV-RNA. The decision
to treat should be made on a case
by case basis, taking into account any evidence of disease progression
such as hepatic inflammation and
fibrosis, as well as prognostic factors for response, HCV genotype and
viral load. The expected benefit of
treatment should be weighed against the safety findings observed for
paediatric subjects in the clinical trials
(see sections 4.4, 4.8 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTR
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Viraferon 1 million IU/ml powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 1 million IU of interferon alfa-2b
produced in _E.coli_ by recombinant DNA
technology.
After reconstitution, 1 ml contains 1 million IU of interferon
alfa-2b.
_ _
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
_ _
White to cream coloured powder.
Clear and colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic Hepatitis B
: Treatment of adult patients with chronic hepatitis B associated with
evidence of hepatitis B
viral replication (presence of HBV-DNA and HBeAg), elevated alanine
aminotransferase (ALT) and
histologically proven active liver inflammation and/or fibrosis.
Chronic Hepatitis C:
_Adult patients: _
Viraferon is indicated for the treatment of adult patients with
chronic hepatitis C who have elevated
transaminases without liver decompensation and who are positive for
serum HCV-RNA or anti-HCV (see
section 4.4).
The best way to use Viraferon in this indication is in combination
with ribavirin.
_Chidren and adolescents: _
Viraferon is intended for use, in a combination regimen with
ribavirin, for the treatment of children and
adolescents 3 years of age and older, who have chronic hepatitis C,
not previously treated, without liver
decompensation, and who are positive for serum HCV-RNA. The decision
to treat should be made on a case
by case basis, taking into account any evidence of disease progression
such as hepatic inflammation and
fibrosis, as well as prognostic factors for response, HCV genotype and
viral load. The expected benefit of
treatment should be weighed against the safety findings observed for
paediatric subjects in the clinical trials
(see sections 4.4, 4.8 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTR
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