PEGASYS SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PEGINTERFERON ALFA-2A

제공처:

PHARMAAND GMBH

ATC 코드:

L03AB11

INN (국제 이름):

PEGINTERFERON ALFA-2A

복용량:

180MCG

약제 형태:

SOLUTION

구성:

PEGINTERFERON ALFA-2A 180MCG

관리 경로:

SUBCUTANEOUS

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

INTERFERONS

제품 요약:

Active ingredient group (AIG) number: 0149481001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2024-02-01

제품 특성 요약

PRODUCT MONOGRAPH
PR
PEGASYS
®
peginterferon alfa-2a injection
Pre-filled syringes: 180 mcg/0.5 mL
Single-use Vials: 180 mcg/1 mL
ProClick
®
Autoinjector: 180 mcg/0.5 mL
Biological Response Modifier
Professed Standard
pharmaand GmbH
Taborstrasse 1
1020 Vienna, Austria
www.pharmaand.com
Imported and Distributed by Accelera Pharma Canada Inc.,
Mississauga, ON L5L 5Z9
Date of Initial Approval:
August 13, 2003
Date of Revision:
February 1, 2024
Submission Control No: 281817
PEGASYS
®
is a registered trade-mark of
pharmaand, used under license
©
Copyright 2021-2028,
pharma& Schweiz GmbH.
PEGASYS
®
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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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
..........................