SUFENTANIL CITRATE INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SUFENTANIL (SUFENTANIL CITRATE)

Verfügbar ab:

HIKMA CANADA LIMITED

ATC-Code:

N01AH03

INN (Internationale Bezeichnung):

SUFENTANIL

Dosierung:

50MCG

Darreichungsform:

SOLUTION

Zusammensetzung:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

100

Verschreibungstyp:

Narcotic (CDSA I)

Therapiebereich:

OPIATE AGONISTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2022-06-07

Fachinformation

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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_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
.........................