Incivo

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Telaprevir 375mg;  

থেকে পাওয়া:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Telaprevir 375 mg

ডোজ:

375 mg

ফার্মাসিউটিকাল ফর্ম:

Film coated tablet

রচনা:

Active: Telaprevir 375mg   Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Croscarmellose sodium Hypromellose acetate succinate Iron oxide yellow Macrogol 3350 Microcrystalline cellulose Polyvinyl alcohol Purified talc Sodium laurilsulfate Sodium stearyl fumarate Titanium dioxide

প্যাকেজ ইউনিট:

Bottle, plastic, HDPE with PP cap, 42 tablets

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

থেরাপিউটিক ইঙ্গিত:

INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): - who are treatment naive - who have previously been treated with interferon alfa (pegylated or nonpegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap - 42 tablets - 24 months from date of manufacture stored at or below 25°C

অনুমোদন তারিখ:

2011-02-18

তথ্য লিফলেট

Page 1 of 5 
INCIVO (120306) ACI 
INCIVO
®

_TELAPREVIR_

FILM-COATED TABLETS 
CONSUMER MEDICINE INFORMATION (CMI) 
WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions 
about Incivo.  It does not contain all of the available 
information.  It does not take the place of talking to 
your doctor or pharmacist. 
IF YOU HAVE ANY CONCERNS ABOUT USING INCIVO, ASK 
YOUR DOCTOR OR PHARMACIST.  Your doctor and 
pharmacist have more information. 
KEEP THIS INFORMATION HANDY. You can refer to it later 
if you have any questions. 
Please also refer to Consumer Medicine Information 
documents of other medicines your doctor may have 
prescribed for use in combination with Incivo. Ask your 
doctor or pharmacist if you have any questions. 
WHAT INCIVO IS USED FOR 
Incivo belongs to a group of medicines called ‘NS3-4A 
protease inhibitors’. It is an inhibitor of the HCV NS3 4A 
protease, an enzyme that is essential for hepatitis C 
virus replication. 
Incivo is part of a treatment for chronic hepatitis C. It 
must be taken in combination with peginterferon alfa 
and ribavirin. This combination of medicines is used to 
treat adult patients (aged 18–65). 
Your doctor, however, may prescribe this medicine for 
another use.  ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED TO 
YOU. 
BEFORE YOU TAKE IT 
_WHEN YOU MUST NOT USE IT _
Do not use Incivo IF YOU KNOW YOU ARE ALLERGIC TO ANY 
OF ITS INGREDIENTS LISTED AT THE END OF THIS LEAFLET. 
Signs of allergy include skin rash, itching, shortness of 
breath, and/or swollen face. 
DO NOT USE IT AFTER THE EXPIRY DATE PRINTED ON THE 
PACK. 
If you use it after the expiry date has passed, it may not 
work as well. 
DO NOT USE IT IF THE PACKAGING IS TORN OR SHOWS 
SIGNS OF BEING TAMPERED WITH. 
DO N

পণ্য বৈশিষ্ট্য

CCDS 121205 and 120625 
Page 1 of 32 
INCIVO (130409) ADS 
DATASHEET 
NAME OF THE MEDICINE 
INCIVO
® 
Telaprevir 

The chemical name
is (1_S_, 3a_R_, 6a_S_)-2-((_S_)-2-{(_S_)-2-Cyclohexyl-2- [(pyrazine-2-carbonyl)-amino] 
-acetylamino}-3,3-dimethyl-butyryl)-octahydro-cyclopenta[c]pyrrole-1-carboxylic
acid ((_S_)-1- 
cyclopropylaminooxalyl-butyl)-amide. 

O
N
O
N
H
O
N
N
H
N
O
H
N
H
N
O
O
(_S_)
(_S_)
(_S_)
(_S_)
(_S_)
(_R_)

Molecular Formula: C
36
H
53
N
7
O
6

CAS: 402957-28-2 

MW: 679.9 
DESCRIPTION

The active ingredient telaprevir is an
inhibitor of the Hepatitis C Virus (HCV) NS3
4A protease, an 
enzyme
that is essential for HCV replication. Telaprevir drug substance is a
white to off-white 
powder with a solubility in water of 0.0047 mg/mL 

INCIVO is available as yellow, caplet-shaped, film-coated
tablets of approximately 20 mm in 
length, marked with “T375” on one side. The inactive
ingredients are hypromellose acetate 
succinate, sodium lauryl sulfate, calcium hydrogen
phosphate anhydrous, croscarmellose sodium, 
cellulose - microcrystalline, silicon
dioxide, sodium stearyl fumarate, polyvinyl alcohol, macrogol 
3350, talc - purified, titanium dioxide and iron oxide
yellow. 
PHARMACOLOGY 
Pharmacotherapeutic group: Direct-acting antiviral. 

PHARMACODYNAMICS 
MECHANISM OF ACTION 
Telaprevir is a specific inhibitor of the HCV NS3 4A serine
protease, which is essential for viral 
replication. 

_In vitro_ studies_ _
_Activity of telaprevir against HCV _
In an HCV subtype 1b replicon assay, the telaprevir IC
50
 value against wild-type HCV was 
0.354 µM similar to a subtype 1a infectious virus assay IC
50
 of 0.28 µM. 

_Resistance _
HCV variants associated with on-treatment virologic failure
or relapse were evaluated by 
CCDS 25Jun13 
Page 2 of 32 
INCIVO (131021) DDS 
site-directed mutag