Ribavirin BioPartners
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
06-05-2013
Charakterystyka produktu
(SPC)
06-05-2013
Sprawozdanie z oceny publicznego
(PAR)
06-05-2013
Składnik aktywny:
Ribavirin
Dostępny od:
BioPartners GmbH
Kod ATC:
J05AB04
INN (International Nazwa):
ribavirin
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
Hepatitis C, Chronic
Wskazania:
Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).Naïve patientsAdult patientsRibavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA) (see section 4.4)Children three years of age and older and adolescentsRibavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).Previous-treatment-failure patientsAdult patientsRibavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2010-04-06
Ulotka dla pacjenta
33
B. PACKAGE LEAFLET
Medicinal product no longer authorised
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIBAVIRIN BIOPARTNERS 200 MG FILM-COATED TABLETS
ribavirin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Ribavirin BioPartners is and what it is used for
2.
Before you take Ribavirin BioPartners
3.
How to take Ribavirin BioPartners
4.
Possible side effects
5.
How to store Ribavirin BioPartners
6.
Further information
1.
WHAT RIBAVIRIN BIOPARTNERS IS AND WHAT IT IS USED FOR
Ribavirin BioPartners contains the active ingredient ribavirin.
Ribavirin BioPartners stops the
multiplication of many types of viruses, including hepatitis C virus.
Ribavirin BioPartners must not be
used without interferon alfa-2b, i.e. Ribavirin BioPartners must not
be used alone.
_Previously untreated patients_
:
The combination of Ribavirin BioPartners with interferon alfa-2b is
used to treat patients 3 years of
age and older who have chronic hepatitis C (HCV) infection, except
genotype 1. For children and
adolescents weighing less than 47 kg a solution formulation is
available.
_Previously treated adult patients_
:
The combination of Ribavirin BioPartners with interferon alfa-2b is
used to treat adult patients with
chronic hepatitis C, who have previously responded to a treatment with
an alpha interferon alone, but
whose condition has recurred.
There is no safety or efficacy information on the use of ribavirin
with other forms of interferon (i.e.,
not alfa-2b).
2.
BEFORE YOU TAKE RIBAVIRIN BIOPARTNERS
Ribavirin BioPartners is not recommended for use in patients under the
age of 3 years.
DO N
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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
Ribavirin BioPartners 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ribavirin BioPartners film-coated tablet contains 200 mg of
ribavirin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, white, biconvex film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ribavirin BioPartners is indicated for the treatment of chronic
hepatitis C virus (HCV) infection in
adults, children 3 years of age and older and adolescents and must
only be used as part of a
combination regimen with interferon alfa-2b. Ribavirin monotherapy
must not be used.
There is no safety or efficacy information on the use of Ribavirin
with other forms of interferon (i.e.,
not alfa-2b).
Naïve patients
_Adult patients: _
Ribavirin BioPartners is indicated, in combination with interferon
alfa-2b, for the
treatment of adult patients with all types of chronic hepatitis C
except genotype 1, not previously
treated, without liver decompensation, with elevated alanine
aminotransferase (ALT), who are positive
for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
_Children 3 years of age and older and adolescents:_
Ribavirin BioPartners is intended for use, in a
combination regimen with interferon alfa-2b, for the treatment of
children 3 years of age and older and
adolescents, who have all types of chronic hepatitis C except genotype
1, not previously treated,
without liver decompensation, and who are positive for HCV-RNA.
When deciding to not to defer treatment until adulthood, it is
important to consider that the
combination therapy induced a growth inhibition. The reversibility of
growth inhibition is uncertain.
The decision to treat should be made on a case by case basis (see
section 4.4).
Previous treatment failure patients
_Adult patients:_
Ribavirin BioPartners is indicated, in combination with interferon
alfa-2b, for the
treatmen
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