Ribavirin Teva Pharma B.V.
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-07-2021
Charakterystyka produktu
(SPC)
09-07-2021
Sprawozdanie z oceny publicznego
(PAR)
09-07-2021
Składnik aktywny:
Ribavirin
Dostępny od:
Teva B.V.
Kod ATC:
J05AP01
INN (International Nazwa):
ribavirin
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
Hepatitis C, Chronic
Wskazania:
Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-07-01
Ulotka dla pacjenta
70
B. PACKAGE LEAFLET
Medicinal product no longer authorised
71
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIBAVIRIN TEVA PHARMA B.V. 200 MG FILM-COATED TABLETS
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 Pharma B.V. is and what it is used for
2.
What you need to know before you use Ribavirin Teva Pharma B.V.
3.
How to use Ribavirin Teva Pharma B.V.
4.
Possible side effects
5.
How to store Ribavirin Teva Pharma B.V.
6.
Contents of the pack and other information
1.
WHAT RIBAVIRIN TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
Ribavirin Teva Pharma B.V. contains the active substance ribavirin.
This medicine stops the
multiplication of hepatitis C virus. Ribavirin Teva Pharma B.V. 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 Pharma B.V. and other medicines is
used to treat patients who
have chronic hepatitis C (HCV).
Ribavirin Teva Pharma B.V. 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
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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 Teva Pharma B.V. 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ribavirin Teva Pharma B.V. tablet contains 200 mg of ribavirin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light pink to pink, (debossed with “93” on one side and “7232”
on the other).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ribavirin Teva Pharma B.V. 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 Pharma B.V. 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 Pharma B.V. 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 Pharma B.V. for additional
prescribing information particular to that
product and for further dosage recommendations on co-administration
with Ribavirin Teva Pharma B.V.
Ribavirin Teva Pharma B.V. tablets 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 Pharma B.V.
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 Pharma B.V.
In the cases in which no specific dose recommendation is made, the
following dose should
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