Viekirax 12.5 mg/75 mg/50 mg Film Coated Tablets

देश: मलेशिया

भाषा: अंग्रेज़ी

स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

सक्रिय संघटक:

RITONAVIR; Ombitasvir; Paritaprevir

थमां उपलब्ध:

ABBVIE SDN BHD

INN (इंटरनेशनल नाम):

RITONAVIR; Ombitasvir; Paritaprevir

पैकेज में यूनिट:

56 Tablets

द्वारा बनाया गया:

Fournier Laboratories Ireland Limited

सूचना पत्रक

_Consumer Medication Information Leaflet (RiMUP)_
VIEKIRAX™ FILM-COATED TABLETS
Ombitasvir 12.5 mg/ Paritaprevir 75 mg/ Ritonavir 50 mg
_____________________________________________________________________________________
______________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Viekirax™ is used for
2. How Viekirax™ works
3. Before you take Viekirax™
4. How to take Viekirax™
5. While you are using
Viekirax™
6. Side effects of Viekirax™
7. Storage and disposal of
Viekirax™
8. Product description
9. Registration Holder
10. Date of revision
11. Serial number
WHAT VIEKIRAX™ 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).
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 leaflets for the
other antiviral medicines that you
take with Viekirax™. If you have
any questions about your
medicines, please ask your doctor
or pharmacist.
HOW VIEKIRAX™ WORKS
It contains the active substances
ombitasvir, paritaprevir and
ritonavir. The combined action
of the threeactive substances
stops the Hepatitis C virus from
multiplying and 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.
BEFORE YOU TAKE VIEKIRAX™
_When you must not take _
_Viekirax™ _

If you are allergic to
ombitasvir, paritaprevir,
ritonavir, or any of the other
ingredients of this medicine
(refer to list of ingredients).

If you have moderate to
severe liver problems other
than Hepatitis C.

If you are taking any of the
medicines listed in the
following table. This is
because serious or life-
threatening effect

उत्पाद विशेषताएं

1
Product Package Insert
Product Name
Ombitasvir 12.5 mg/ Paritaprevir 75 mg/ Ritonavir 50 mg
Trade Name
Viekirax 12.5 mg / 75 mg/ 50 mg Film-Coated Tablets
Description and Composition
Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir. The tablet is pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1’.
Excipients for tablet: Copovidone, Vitamin E polyethylene glycol succinate, Propylene glycol monolaurate, Sorbitan monolaurate, Colloidal anhydrous silica, Sodium stearyl fumarate.
Excipients for film-coating: Polyvinyl alcohol, Polyethylene glycol 3350, Talc, Titanium dioxide, Iron oxide red. This product does not contain gluten.
Indication and Usage
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections Dosage and Administration, Special Warnings and Precautions, and Pharmacodynamic Properties).
For hepatitis C virus (HCV) genotype specific activity, see sections on Special Warnings and Precautions and Pharmacodynamic Properties.
Dosage and 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).