SUFENTANIL CITRATE INJECTION SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

SUFENTANIL (SUFENTANIL CITRATE)

Dostupno od:

HIKMA CANADA LIMITED

ATC koda:

N01AH03

INN (International ime):

SUFENTANIL

Doziranje:

50MCG

Farmaceutski oblik:

SOLUTION

Sastav:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

100

Tip recepta:

Narcotic (CDSA I)

Područje terapije:

OPIATE AGONISTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2022-06-07

Svojstava lijeka

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