SUFENTANIL CITRATE INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

SUFENTANIL (SUFENTANIL CITRATE)

Dostupné s:

HIKMA CANADA LIMITED

ATC kód:

N01AH03

INN (Mezinárodní Name):

SUFENTANIL

Dávkování:

50MCG

Léková forma:

SOLUTION

Složení:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Podání:

INTRAVENOUS

Jednotky v balení:

100

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-06-07

Charakteristika produktu

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
.........................