Victrelis

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Boceprevir

Pieejams no:

Merck Sharp & Dohme Australia Pty Ltd

Klase:

Medicine Registered

Lietošanas instrukcija

VICTRELIS
®
CAPSULES

_Boceprevir_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about VICTRELIS
Capsules. It does not contain all of
the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using VICTRELIS
Capsules against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY WANT TO READ IT AGAIN.
WHAT VICTRELIS IS
USED FOR?
VICTRELIS Capsules contain a
medicine called boceprevir.
VICTRELIS stops the multiplication
of the hepatitis C virus. VICTRELIS
works by lowering the amount of
Hepatitis C Virus in your body.
VICTRELIS Capsules must only be
used in combination with two other
medicines (peginterferon alfa and
ribavirin) for the treatment of chronic
hepatitis C Type 1 virus infection in
adults. Peginterferon alfa belongs to
a group of medicines called
interferons. Ribavirin is an antiviral
agent.
Combination therapy with
VICTRELIS Capsules is used for the
treatment of chronic hepatitis C (a
viral infection of the liver) Type 1 in
patients (18 years or older) who have
compensated liver disease and who
either have not previously received,
or have failed, interferon alfa
treatment (pegylated or
nonpegylated).
BEFORE YOU USE
VICTRELIS CAPSULES
SINCE VICTRELIS MUST BE TAKEN
IN COMBINATION WITH PEGINTERFERON
ALFA AND RIBAVIRIN, CERTAIN WARNING
IN THIS CONSUMER MEDICINE
INFORMATION ARE DETAILED HERE
BECAUSE THEY RELATE TO VICTRELIS
OR PEGINTERFERON ALFA OR RIBAVIRIN.
You must tell any doctor that is
prescribing medicine to you about all
the medicines you take, including
VICTRELIS, other prescription and
non-prescription medicines, vitamins
and herbal supplements
Many prescription medicines, over
the counter, and complementary
medicines have the potential to
interact with VICTRELIS. This can
cause you to have too mu

Produkta apraksts

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PRODUCT INFORMATION 
VICTRELIS

 (BOCEPREVIR) CAPSULES 
NAME OF THE MEDICINE 
VICTRELIS 

Boceprevir has the following structural formula: 

CAS registry number: 394730-60-0 
Boceprevir has the following chemical name: (1R,5S)-N-[3-Amino-1-(cyclobutylmethyl)-2,3-
dioxopropyl]-3-[2(S)-[[[(1,1-dimethylethyl)amino]carbonyl]amino]-3,3-dimethyl-1-oxobutyl]-6,6-
dimethyl-3-azabicyclo[3.1.0]hexan-2(S)-carboxamide.  
The molecular formula is C
27
H
45
N
5
O
5
 and its molecular weight is 519.7.  
DESCRIPTION 
VICTRELIS (boceprevir) is an inhibitor of the Hepatitis
C Virus (HCV) non-structural protein 3 
(NS3) serine protease. Boceprevir is manufactured
as an approximately equal mixture of two 
diastereomers.  
Boceprevir is a white to off-white
amorphous powder. It is freely soluble in methanol, ethanol 
and isopropanol and slightly soluble in water with
a partition coefficient (logP
octanol/water
) of 3.0. _ _
VICTRELIS 200 mg capsules are available
as hard gelatin capsules for oral administration. 
Each capsule contains 200 mg
of boceprevir and the following inactive ingredients: sodium 
lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-
gelatinized starch, and magnesium stearate. 
The yellowish-brown opaque cap consists of gelatin, E172
Red Iron Oxide, E172 Yellow Iron 
Oxide and titanium dioxide. The off-white
opaque body contains gelatin, titanium dioxide and 
E172 Yellow Iron Oxide.  
The capsule is printed in red ink (Red SB-1100). The red ink
contains Shellac, Ph.Eur., Ethanol 
anhydrous, Ph.Eur., Isopropyl alcohol  
PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES  
A direct-acting antiviral for treatment of Chronic Hepatitis
C._ _

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Mechanism of action 
VICTRELIS is an inhibitor of the HCV NS3
proteas