Viekirax
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
05-03-2018
Fachinformation
(SPC)
05-03-2018
Öffentlichen Beurteilungsberichts
(PAR)
08-02-2018
Wirkstoff:
ombitasvir / paritaprevir / ritonavir
Verfügbar ab:
AbbVie Ltd
INN (Internationale Bezeichnung):
ombitasvir / paritaprevir / ritonavir
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
Hepatitis C, Chronic
Anwendungsgebiete:
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2015-01-15
Gebrauchsinformation
69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIEKIRAX 12.5 MG/75 MG/50 MG FILM-COATED TABLETS
ombitasvir/paritaprevir/ritonavir
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 Viekirax is and what it is used for
2.
What you need to know before you take Viekirax
3.
How to take Viekirax
4.
Possible side effects
5.
How to store Viekirax
6.
Contents of the pack and other information
1.
WHAT VIEKIRAX IS AND WHAT IT IS USED FOR
Viekirax is an antiviral medicine used to treat adults with chronic
(long-term) hepatitis C (an infectious
disease that affects the liver, caused by the hepatitis C virus). It
contains the active substances ombitasvir,
paritaprevir and ritonavir.
The combined action of the three active substances stops the hepatitis
C virus from multiplying and
infecting new cells, thus clearing the virus from your blood over a
period of time. Ombitasvir and
paritaprevir block two proteins essential for the virus to multiply.
Ritonavir acts as a ‘booster’ to prolong
the action of paritaprevir in the body.
Viekirax tablets are taken with other antiviral medicines
_ _
such as dasabuvir and ribavirin. Your doctor will
talk with you about which of these medicines to take with Viekirax.
It is very important that you also read the package l
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions
.
1.
NAME OF THE MEDICINAL PRODUCT
Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of
paritaprevir and 50 mg of ritonavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x
10.0 mm, debossed on one side with
‘AV1’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Viekirax 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).
For hepatitis C virus (HCV) genotype specific activity, see sections
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Viekirax should be initiated and monitored by a
physician experienced in the management
of chronic hepatitis C.
Posology
The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg
tablets once daily with food.
Viekirax should be used in combination with other medicinal products
for the treatment of HCV (see
Table 1).
3
TABLE 1. RECOMMENDED CO-ADMINISTERED MEDICINAL PRODUCT(S) AND
TREATMENT DURATION FOR VIEKIRAX
BY PATIENT POPULATION
PATIENT POPULATION
TREATMENT*
DURATION
GENOTYPE 1B, WITHOUT CIRRHOSIS OR
WITH COMPENSATED CIRRHOSIS
Viekirax + dasabuvir
12 weeks
8 weeks may be considered in
previously untreated genotype 1b-
infected patients with minimal to
moderate fibrosis**
(see section 5.1,
GARNET study)
GENOTYPE 1A,
WITHOUT CIRRHOSIS
Viekirax + dasabuvir + ribavirin*
12 weeks
GENOTYPE 1A,
WITH COMPENSATED CIRRHOSIS
Viekirax + dasabuvir + ribavirin*
24 weeks (see section 5.1.)
GENOTYPE 4, WITHOUT CIRRHOSIS OR
WITH COMPENSATED
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