SUFENTANIL CITRATE INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SUFENTANIL (SUFENTANIL CITRATE)

Boleh didapati daripada:

HIKMA CANADA LIMITED

Kod ATC:

N01AH03

INN (Nama Antarabangsa):

SUFENTANIL

Dos:

50MCG

Borang farmaseutikal:

SOLUTION

Komposisi:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100

Jenis preskripsi:

Narcotic (CDSA I)

Kawasan terapeutik:

OPIATE AGONISTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-06-07

Ciri produk

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