SUFENTANIL CITRATE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SUFENTANIL (SUFENTANIL CITRATE)

Disponible depuis:

HIKMA CANADA LIMITED

Code ATC:

N01AH03

DCI (Dénomination commune internationale):

SUFENTANIL

Dosage:

50MCG

forme pharmaceutique:

SOLUTION

Composition:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Narcotic (CDSA I)

Domaine thérapeutique:

OPIATE AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2022-06-07

Résumé des caractéristiques du produit

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