AVONEX POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

INTERFERON BETA-1A; WATER

可用日期:

BIOGEN CANADA INC

ATC代码:

L03AB07

INN（国际名称）:

INTERFERON BETA-1A

剂量:

30MCG; 1.1ML

药物剂型:

POWDER FOR SOLUTION

组成:

INTERFERON BETA-1A 30MCG; WATER 1.1ML

给药途径:

INTRAMUSCULAR

每包单位数:

1.1ML

处方类型:

Prescription

治疗领域:

Immunomodulatory Agents

產品總結:

Active ingredient group (AIG) number: 0231060002; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2010-10-30

产品特点

_Pr_
_AVONEX_
_®_
_ (interferon beta-1a), _
_Pr_
_AVONEX_
_®_
_ PS (interferon beta-1a) _
_01 May 2008 _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
AVONEX
®
(interferon beta-1a)
Lyophilized powder for reconstitution
PR
AVONEX
® PS
(interferon beta-1a)
Liquid for injection in prefilled syringe
Immunomodulator
Biogen Idec Canada Inc.
3 Robert Speck Parkway, Suite 300
Mississauga, ON L4Z 2G5
Date of Revision:
01 May 2008
Submission Control No: 116304
Date of Approval May 28, 2009
_ _
_Pr_
_AVONEX_
_®_
_ (interferon beta-1a), _
_Pr_
_AVONEX_
_®_
_ PS (interferon beta-1a) _
_01 May 2008 _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................4
CONTRAINDICATIONS
...................................................................................................7
WARNINGS AND
PRECAUTIONS..................................................................................7
ADVERSE
REACTIONS..................................................................................................12
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND
STABILITY..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
....................................................