REBIF SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

INTERFERON BETA-1A

제공처:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATC 코드:

L03AB07

INN (국제 이름):

INTERFERON BETA-1A

복용량:

8.8MCG

약제 형태:

SOLUTION

구성:

INTERFERON BETA-1A 8.8MCG

관리 경로:

SUBCUTANEOUS

패키지 단위:

6X0.2ML

처방전 유형:

Prescription

치료 영역:

Immunomodulatory Agents

제품 요약:

Active ingredient group (AIG) number: 0131806005; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2013-08-09

제품 특성 요약

Document No. 0900babe80642556 v1.0
Object No. 0900babe80642569
C O N F I D E N T I A L
I N F O R M A T I O N
1/92
PRODUCT MONOGRAPH
PR
REBIF
®
(Interferon beta-1a)
8.8 μg/0.2 mL, 22 μg/0.5 mL and 44 μg/0.5 mL
Solution for Injection in Pre-filled Syringes
Multidose 22 µg × 3 (66 µg/1.5 mL)
Multidose 44 µg × 3 (132 µg/1.5 mL)
Solution for Injection in Pre-filled Cartridges
Pr
REBIF
®
RebiDose
®
8.8 μg/0.2 mL, 22 μg/0.5 mL and 44 μg/0.5 mL
Solution for Injection in Pre-filled Pens
Immunomodulator
EMD SERONO, A DIVISION OF EMD INC., CANADA
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, L5K 2N6
Date of Approval:
May 08, 2013
Submission Control No.: 163275
®
Registered trademark of Ares Trading S.A.
Document No. 0900babe80642556 v1.0
Object No. 0900babe80642569
C O N F I D E N T I A L
I N F O R M A T I O N
2/92
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
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
43
OVERDOSAGE
...............................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 45
STORAGE AND STABILITY
.................................................