MODERIBA

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

RIBAVIRIN

זמין מ:

AbbVie Limited

קוד ATC:

J05AB04

INN (שם בינלאומי):

RIBAVIRIN

כמות:

200 Milligram

טופס פרצבטיות:

Film Coated Tablet

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

ribavirin

מצב אישור:

Not Marketed

תאריך אישור:

2010-06-18

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MODERIBA 200 MG FILM-COATED TABLETS
MODERIBA 400 MG FILM-COATED TABLETS
MODERIBA 600 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Moderiba is and what it is used for
2.
What you need to know before you take Moderiba
3.
How to take Moderiba
4.
Possible side effects
5.
How to store Moderiba
6.
Contents of the pack and other information
1.
WHAT MODERIBA IS AND WHAT IT IS USED FOR
Ribavirin, which is the antiviral active substance in Moderiba,
inhibits the multiplication of many types of
viruses, including the hepatitis C viruses (which can cause an
infection of the liver called hepatitis C).
Moderiba is used in combination with other medicines to treat certain
chronic forms of hepatitis C.
Moderiba should only be used in combination with other medicines to
treat hepatitis C. It should not be
taken alone.
Please also read the package leaflets of the other medicines that are
used in combination with Moderiba.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODERIBA
DO NOT TAKE MODERIBA:

if you are allergic to ribavirin or any of the other ingredients of
this medicine (listed in section 6).

if you are pregnant or breast-feeding (see section ‘Pregnancy and
breast-feeding’).

if you have had a heart attack or have suffered from any other severe
heart disease in the previous six
months.

if you have a blood disorder such as sickle-cell anaemia or
thalassaemia (weakening and destruction of
red blood cells).
Please

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moderiba 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ribavirin.
Excipient with known effect
Each film-coated tablet contains 15 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Unscored blue capsule-shaped film-coated tablet, of dimensions 12.0 mm
x 6.0 mm, debossed with ‘3RP’ on one side
and ’200’ on the other
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderiba is indicated in combination with other medicinal products,
for the treatment of chronic hepatitis C (CHC).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored by a physician experienced
in the management of chronic hepatitis C.
Refer also to the SmPC of the medicinal product(s) used in combination
with Moderiba for the treatment of hepatitis C.
Method of administration
Moderiba film-coated tablets are administered orally in two divided
doses (morning and evening) with food.
Due to
the teratogenic potential of ribavirin, the tablets should not be
broken or crushed.
Posology
_Dose to be administered_
The dose of Moderiba is based on patient body weight, viral genotype
and the medicinal product that is used in
combination (see Table 1).
Moderiba tablets are to be administered orally each day in two divided
doses (morning and
evening) with food.
TABLE 1:
MODERIBA DOSING RECOMMENDATION ACCORDING TO THE MEDICINAL PRODUCT(S)
USED IN COMBINATION
MEDICINAL PRODUCT USED IN
COMBINATION
DAILY MODERIBA DOSE
NUMBER OF 200/400/600 MG
TABLETS
Direct acting antivirals (DAA)
<75 kg = 1000 mg
>75 kg = 1200 mg
5 x 200 mg
(2 morning, 3 evening)
6 x 200 mg
(3 morning, 3 evening)
or
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