REBETOL

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

RIBAVIRIN

Saadav alates:

MERCK SHARP & DOHME ISRAEL LTD

ATC kood:

J05AB04

Ravimvorm:

CAPSULES

Koostis:

RIBAVIRIN 200 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

SCHERING-PLOUGH LABO. N.V , BELGIUM

Terapeutiline rühm:

RIBAVIRIN

Terapeutiline ala:

RIBAVIRIN

Näidustused:

Tritherapy:Rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis C (CHC) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.Bitherapy:Rebetol is indicated for the treatment of chronic hepatitis C virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b .Rebetol monotherapy must not be used. There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).Previously untreated (naïve) patientsAdult patients (18 years of age or older): Rebetol is indicated for:• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis C genotype1 infection with compensated liver disease.• bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, fo

Loa andmise kuupäev:

2014-10-31

Infovoldik

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
REBETOL
®
200 MG
CAPSULES
Each capsule contains:
Ribavirin 200 mg
For a list of inactive ingredients see section 6.1 "What REBETOL
contains". See also section 2.7 “Important
information about some of the ingredients of REBETOL".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

This leaflet contains concise information about REBETOL. 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 medical condition seems similar to yours.

This medicine is intended for adult patients. This medicine is not
intended for children and
adolescents under 18 years of age.
1. WHAT REBETOL IS AND WHAT IT IS USED FOR?
REBETOL capsules contain the active substance ribavirin. This medicine
stops the multiplication of
many types of viruses, including hepatitis C virus. REBETOL capsules
are intended to treat patients 18 years
of age or older who have chronic hepatitis C.
This medicine must not be used without peginterferon alfa-2b or
interferon alfa-2b, i.e. REBETOL 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 boceprevir and peginterferon
alfa-2b (tritherapy).
Adult patients without genotype 1, can only use peginterferon alfa-2b
or interferon alfa-2b and this medicine
(bitherapy).
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 this medicine and peginterferon alfa-2b is used to
treat previously untreated adult
patients who have chronic hepatitis C (HCV) infection and who are
co-infected with clinically stable
HIV.
There is no safety or efficacy information on the use

Toote omadused

1
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Rebetol
®
200 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg of ribavirin.
Excipient with known effect:
Each capsule contains 40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
White, opaque and imprinted with blue ink.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
Tritherapy:
Rebetol in combination with boceprevir and peginterferon alfa-2b is
indicated for the treatment of
chronic hepatitis C (CHC) genotype1 infection in adults patients (18
years of age and older) with
compensated liver disease who are previously untreated or who have
failed previous therapy.
Please refer to peginterferon alfa -2b and boceprevir Summary of
Product Characteristics (SmPCs)
when using Rebetol in combination with these medicines.
Bitherapy:
Rebetol is indicated for the treatment of chronic hepatitis C virus
infection in adults and must only
be used as part of a combination regimen with peginterferon alfa-2b or
interferon alfa-2b. Rebetol
monotherapy must not be used.
Please refer to interferon alfa-2b and peginterferon alfa-2b Summary
of Product Characteristics
(SmPCs) when using Rebetol in combination with these medicines.
There is no safety or efficacy information on the use of Rebetol with
other forms of interferon (i.e., not
alfa-2b).
Previously untreated (naïve) patients
_Adult patients_
_(18 years of age or older): _Rebetol is indicated for:

tritherapy- in combination with peginterferon alfa-2b and boceprevir
for the treatment of
adult patients with chronic hepatitis C genotype1 infection with
compensated liver disease

bitherapy- in combination with interferon alfa-2b or peginterferon
alfa-2b, for the treatment
of adult patients with chronic hepatitis C, not previously treated,
without liver
decompensation, with elevated alanine aminotransferase (ALT), who are
positive for
hepatitis C viral ribonucleic acid (HCV-RNA).

bitherapy- for the treatment of CHC infection in co