SUFENTANIL CITRATE INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SUFENTANIL (SUFENTANIL CITRATE)

から入手可能:

HIKMA CANADA LIMITED

ATCコード:

N01AH03

INN（国際名）:

SUFENTANIL

投薬量:

50MCG

医薬品形態:

SOLUTION

構図:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Narcotic (CDSA I)

治療領域:

OPIATE AGONISTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2022-06-07

製品の特徴

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 _
_ _
_Page 2 of 42_
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
.........................