PEGETRON CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
01-02-2017

有効成分:

RIBAVIRIN; PEGINTERFERON ALFA-2B

から入手可能:

MERCK CANADA INC

ATCコード:

L03AB60

INN(国際名):

PEGINTERFERON ALFA-2B, COMBINATIONS

投薬量:

200MG; 120MCG

医薬品形態:

CAPSULE

構図:

RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 120MCG

投与経路:

ORAL

パッケージ内のユニット:

2X0.675ML-70 CAPS

処方タイプ:

Prescription

治療領域:

INTERFERONS

製品概要:

Active ingredient group (AIG) number: 0247602008; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2017-10-05

製品の特徴

                                PR
PEGETRON
® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH
PAGE 1 OF 70
PRODUCT MONOGRAPH
PEGETRON
®
RIBAVIRIN PLUS PEGINTERFERON ALFA-2B
RIBAVIRIN 200 MG CAPSULES
PLUS
PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN VIALS:
50 MCG/0.5 ML
150 MCG/0.5 ML
RIBAVIRIN 200 MG CAPSULES
PLUS _ _
PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN CLEARCLICK™ SINGLE DOSE
DELIVERY SYSTEM:_ _
80 MCG/0.5 ML
100 MCG/0.5 ML
120 MCG/0.5 ML
150 MCG/0.5 ML
ANTIVIRAL AGENT PLUS BIOLOGICAL RESPONSE MODIFIER
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, Quebec H9H 4M7
www.merck.ca
Submission Control No: 201233
Date of Approval:
February 1, 2017
PR
PEGETRON
® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH
PAGE 2 OF 70
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 34
STORAGE AND STABILITY
...............................................
                                
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