SUFENTANIL CITRATE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SUFENTANIL (SUFENTANIL CITRATE)

제공처:

HIKMA CANADA LIMITED

ATC 코드:

N01AH03

INN (국제 이름):

SUFENTANIL

복용량:

50MCG

약제 형태:

SOLUTION

구성:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

관리 경로:

INTRAVENOUS

패키지 단위:

100

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0144821001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-06-07

제품 특성 요약

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
SUFENTANIL CITRATE INJECTION
50 mcg/mL sufentanil
(as sufentanil citrate)
Preservative free sterile aqueous solution
For Intravenous and Epidural use
Hikma Standard
Opioid Analgesic
Adjunct to Anesthesia
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
SUBMISSION CONTROL NO.: 264335
Date of
Preparation:
June 6, 2022
_Sufentanil Citrate Injection _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
.........................