Ribavirin Teva
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
09-07-2021
Valmisteyhteenveto
(SPC)
09-07-2021
Julkisesta arviointikertomuksesta
(PAR)
09-07-2021
Aktiivinen ainesosa:
Ribavirin
Saatavilla:
Teva B.V.
ATC-koodi:
J05AB04
INN (Kansainvälinen yleisnimi):
ribavirin
Terapeuttinen ryhmä:
Antivirals for systemic use
Terapeuttinen alue:
Hepatitis C, Chronic
Käyttöaiheet:
Ribavirin Teva 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 Teva 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.Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa2b, 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 HCV-RNA.When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis.Previous treatment failure patientsAdult patients Ribavirin Teva 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.
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2009-03-31
Pakkausseloste
37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIBAVIRIN TEVA 200MG 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 Teva is and what it is used for
2.
What you need to know before you use Ribavirin Teva
3.
How to use Ribavirin Teva
4.
Possible side effects
5.
How to store Ribavirin Teva
6.
Contents of the pack and other information
1.
WHAT RIBAVIRIN TEVA IS AND WHAT IT IS USED FOR
Ribavirin Teva contains the active substance ribavirin. This medicine
stops the multiplication of
hepatitis C virus. Ribavirin Teva 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 Teva and other medicines is used to treat
patients who have chronic
hepatitis C (HCV).
Ribavirin Teva may be used in paediatric patients (children 3 years of
age and older and adolescents)
who are not previously treated and without severe liver disease.
For paediatric patients (children and adolescents) weighing less than
47 kg a solution formulation is
available.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Ribavirin Teva 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ribavirin Teva capsule contains 200 mg of ribavirin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White, opaque and imprinted with blue ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ribavirin Teva is indicated in combination with other medicinal
products for the treatment of chronic
hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Ribavirin Teva is indicated in combination with other medicinal
products for the treatment of chronic
hepatitis C (CHC) for paediatric patients (children 3 years of age and
older and adolescents) not
previously treated and without liver decompensation (see sections 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated, and monitored, by a physician
experienced in the management of
chronic hepatitis C.
Posology
Ribavirin Teva must be used in combination therapy as described in
section 4.1.
Please refer to the corresponding Summary of Product Characteristics
(SmPC) of medicinal products
used in combination with Ribavirin Teva for additional prescribing
information particular to that
product and for further dosage recommendations on co-administration
with Ribavirin Teva.
Ribavirin Teva capsules are to be administered orally each day in two
divided doses (morning and
evening) with food.
_Adults: _
The recommended dose and duration of Ribavirin Teva depends on
patient’s weight and on the
medicinal product that is used in combination. Please refer to the
corresponding SmPC of medicinal
products used in combination with Ribavirin Teva.
In the cases in which no specific dose recommendation is made, the
following dose should be used:
Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
_Paediatric population: _
No data are available in children below 3 years of age.
Note: For patients who
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