VICTRELIS TRIPLE CAPSULE
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
14-09-2015
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
BOCEPREVIR; RIBAVIRIN; PEGINTERFERON ALFA-2B
थमां उपलब्ध:
MERCK CANADA INC
ए.टी.सी कोड:
L03AB60
INN (इंटरनेशनल नाम):
PEGINTERFERON ALFA-2B, COMBINATIONS
डोज़:
200MG; 200MG; 150MCG
फार्मास्यूटिकल फॉर्म:
CAPSULE
रचना:
BOCEPREVIR 200MG; RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG
प्रशासन का मार्ग:
ORAL
पैकेज में यूनिट:
168 BOC CAPS 84/98 RBV CAPS AND 2 REDIPEN
प्रिस्क्रिप्शन प्रकार:
Prescription
चिकित्सीय क्षेत्र:
INTERFERONS
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 0352956004; AHFS:
प्राधिकरण का दर्जा:
CANCELLED POST MARKET
प्राधिकरण की तारीख:
2016-09-02
उत्पाद विशेषताएं
_VICTRELIS TRIPLE_
®
_ (boceprevir, ribavirin plus peginterferon alfa-2b) _
_ Page 1 of 97 _
_ _
PRODUCT MONOGRAPH
VICTRELIS TRIPLE
®
VICTRELIS
®
boceprevir capsules, 200 mg
Hepatitis C Virus (HCV) Protease Inhibitor (PI)
PLUS
PEGETRON
®
ribavirin capsules, 200 mg
Antiviral Agent
plus
peginterferon alfa-2b powder for solution in CLEARCLICK
TM
single dose delivery system:_ _
80 mcg/0.5 mL
100 mcg/0.5 mL
120 mcg/0.5 mL
150 mcg/0.5 mL, when reconstituted
Biological Response Modifier
NOTE: THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. THE
INDIVIDUAL
PRODUCTS CONTAINED IN VICTRELIS TRIPLE
® SHOULD NOT BE USED ALONE OR IN
COMBINATION FOR OTHER PURPOSES. THE INFORMATION DESCRIBED IN THIS
PRODUCT
MONOGRAPH CONCERNS ONLY THE USE OF THESE PRODUCTS. FOR INFORMATION ON
THE
USE OF THE INDIVIDUAL COMPONENTS WHEN DISPENSED AS INDIVIDUAL
MEDICATIONS
OUTSIDE THIS COMBINED USE FOR THE TREATMENT OF CHRONIC HEPATITIS C
(CHC), THE
RESPECTIVE PRODUCT MONOGRAPHS FOR THESE PRODUCTS SHOULD BE CONSULTED.
MERCK CANADA INC.
16750, route Transcanadienne
Kirkland, QC Canada H9H 4M7
http://www.merck.ca
SUBMISSION CONTROL NO: 185622
Date of Revision:
September 11, 2015
_VICTRELIS TRIPLE_
®
_ (boceprevir, ribavirin plus peginterferon alfa-2b) _
_ Page 2 of 97 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
ADVERSE REACTIONS
...................................................................................................
18
DRUG INTERACTIONS
...................................................................................................
28
DOSAGE AND ADMINISTRATION
.........................................................
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