MARCAINE SOLUTION

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언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
06-09-2017

유효 성분:

BUPIVACAINE HYDROCHLORIDE

제공처:

PFIZER CANADA ULC

ATC 코드:

N01BB01

INN (국제 이름):

BUPIVACAINE

복용량:

125MG

약제 형태:

SOLUTION

구성:

BUPIVACAINE HYDROCHLORIDE 125MG

관리 경로:

BLOCK/INFILTRATION

패키지 단위:

50ML

처방전 유형:

Ethical

치료 영역:

LOCAL ANESTHETICS

제품 요약:

Active ingredient group (AIG) number: 0108896001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2004-05-04

제품 특성 요약

                                PRODUCT MONOGRAPH
MARCAINE
®
(Bupivacaine Hydrochloride Injection USP)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
MARCAINE
® SPINAL
(Bupivacaine Hydrochloride in Dextrose Injection USP)
7.5 mg/mL
MARCAINE
® E
(Bupivacaine Hydrochloride and Epinephrine Injection USP)
Bupivacaine Hydrochloride 2.5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Bupivacaine Hydrochloride 5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Sterile Solution
Local Anesthetic
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 208287
Date of Revision:
September 6, 2017
_Product Monograph – Marcaine_
_®_
_, Marcaine_
_®_
_ Spinal, Marcaine_
_®_
_ E _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION
                                
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