PEGETRON CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RIBAVIRIN; PEGINTERFERON ALFA-2B

제공처:

MERCK CANADA INC

ATC 코드:

L03AB60

INN (International Name):

PEGINTERFERON ALFA-2B, COMBINATIONS

복용량:

200MG; 150MCG

약제 형태:

CAPSULE

구성:

RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG

관리 경로:

ORAL

패키지 단위:

2X0.7ML-84CAPS/2X0.7ML-98CAPS

처방전 유형:

Prescription

치료 영역:

INTERFERONS

제품 요약:

Active ingredient group (AIG) number: 0247602005; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-04-04

제품 특성 요약

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
...............................................