SUFENTANIL CITRATE INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

SUFENTANIL (SUFENTANIL CITRATE)

Dostopno od:

HIKMA CANADA LIMITED

Koda artikla:

N01AH03

INN (mednarodno ime):

SUFENTANIL

Odmerek:

50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

100

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

OPIATE AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-06-07

Lastnosti izdelka

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