SUFENTANIL CITRATE INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SUFENTANIL (SUFENTANIL CITRATE)

Commercializzato da:

HIKMA CANADA LIMITED

Codice ATC:

N01AH03

INN (Nome Internazionale):

SUFENTANIL

Dosaggio:

50MCG

Forma farmaceutica:

SOLUTION

Composizione:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-06-07

Scheda tecnica

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