Victrelis

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Boceprevir 200mg

Saadav alates:

Merck Sharp & Dohme (New Zealand) Limited

INN (Rahvusvaheline Nimetus):

Boceprevir 200 mg

Annus:

200 mg

Ravimvorm:

Capsule

Koostis:

Active: Boceprevir 200mg Excipient: Capsugel yellow 2276 Capsugel yellow 4077 Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Sodium laurilsulfate Tekprint red SB-1100

Ühikuid pakis:

Blister pack, PVC/PCTFE/Al blisters x84/carton x4 cartons, 336 capsules

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

MSD International GmbH (Singapore Branch)

Näidustused:

Victrelis (boceprevir) is indicated for the treatment of Chronic Hepatitis C (HCV) genotype 1 infection, in a combination regimen with peginterferon alpha and ribavirin, in adult patients (18 years and older) with compensated liver disease who are previously untreated or who have failed previous therapy.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Al blisters x84/carton x4 cartons - 336 capsules - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light and moisture 3 months opened stored at or below 30°C protect from light and moisture

Loa andmise kuupäev:

2012-01-31

Infovoldik

 
Page 1 
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. 
_When you must not use it: _
DO NOT USE VICTRELIS CAPSULES IF 
YOU ARE ALLERGIC TO BOCEPREVIR OR ANY 
OF THE ING

Toote omadused

Ref: LRN 503034-BCV-CP-USPI-1; LRN 503034-BCV-CP-CCDS-3 A120726 v1.0 
Page 1 of 25 

NEW ZEALAND DATA SHEET 
 VICTRELIS
®
 (BOCEPREVIR) CAPSULES 

NAME OF THE MEDICINE 
VICTRELIS

Boceprevir has the following structural formula: 

N
H
N
HN
O
O
H
N
O
NH
2
O
O

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._ _
Ref: LRN 503034-BCV-CP-USPI-1; LRN 503034-BCV-CP-CCDS-3 A120726 v1.0 
Page 2 of 25 

Mechanism of action 
VICTRELIS is an inhibitor of the HCV NS3 protease. VICTRELIS
covale