Ribavirin Mylan (previously Ribavirin Three Rivers)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Ribavirin

Available from:

Mylan S.A.S

ATC code:

J05AB04

INN (International Name):

ribavirin

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

Hepatitis C, Chronic

Therapeutic indications:

Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.Naïve patientsAdult patientsRibavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.Children and adolescentsRibavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum 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).Previously treatment-failure patientsAdult patientsRibavirin Mylan 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 alpha monotherapy but who have subsequently relapsed.

Product summary:

Revision: 10

Authorization status:

Withdrawn

Authorization date:

2010-06-10

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIBAVIRIN MYLAN 200 MG HARD CAPSULES
ribavirin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Ribavirin Mylan is and what it is used for
2.
What you need to know before you take Ribavirin Mylan
3.
How to take Ribavirin Mylan
4.
Possible side effects
5.
How to store Ribavirin Mylan
6.
Contents of the pack and other information
1.
WHAT RIBAVIRIN MYLAN IS AND WHAT IT IS USED FOR
Ribavirin Mylan contains the active substance ribavirin. This medicine
stops the multiplication of
hepatitis C virus. Ribavirin Mylan must not be used without interferon
alfa-2b, i.e. Ribavirin Mylan
must not be used alone.
Depending on the genotype of the hepatitis C virus that you have, your
doctor may choose to treat you
with a combination of this medicine with other medicines. There may be
some further treatment
limitations if you have or have not been previously treated for
chronic hepatitis C infection. Your
doctor will recommend the best course of therapy.
The combination of Ribavirin Mylan and other medicines is used to
treat adult patients who have
chronic hepatitis C (HCV).
_Previously untreated patients_
:
The combination of Ribavirin Mylan with interferon alfa-2b is used in
paedriatic patientes (children
3 years of age and older) who have chronic hepatitis C (HCV)
infection.
For paediatric patients (children and adolescents) weighing less than
47 kg a solution formulation is
available.
_Previously treated adult patients_
:
The

Summary of Product characteristics

1
_ _
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ribavirin Mylan 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg of ribavirin.
Excipient with known effect: each hard capsule contains 15 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White opaque body imprinted "riba/200" in green and a white opaque cap
imprinted "riba/200" in
green.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ribavirin Mylan is indicated for the treatment of chronic hepatitis C
(CHC) and must only be used as
part of a combination regimen with interferon alfa-2b (adults,
children (3 years of age and older) and
adolescents). 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).
Please refer also to the interferon alfa-2b Summary of Product
Characteristics (SmPC) for prescribing
information particular to that product.
Naïve patients
_Adult Patients (18 years of age or older)_
: Ribavirin Mylan 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 serum HCV-RNA (see section 4.4).
_Paediatric patients (children 3 years of age and older and
adolescents):_
Ribavirin Mylan is indicated,
in a combination regimen with interferon alfa-2b, for the treatment of
children and adolescents 3 years
of age and older, who have all types of chronic hepatitis C except
genotype 1, not previously treated,
without liver decompensation, and who are positive for serum HCV-RNA.
When deciding not to
defer treatment until adulthood, it is important to consider that the
combination therapy can induce a
growth inhibition that may be irreversible in some patients. The
decision to treat should be made