REMIFENTANIL HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Disponibbli minn:

STERIMAX INC

Kodiċi ATC:

N01AH06

INN (Isem Internazzjonali):

REMIFENTANIL

Dożaġġ:

2MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

5ML

Tip ta 'preskrizzjoni:

Narcotic (CDSA I)

Żona terapewtika:

OPIATE AGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0133098002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2011-05-10

Karatteristiċi tal-prodott

_Remifentanil Hydrochloride for Injection - Product Monograph _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
N
REMIFENTANIL HYDROCHLORIDE FOR INJECTION
1 mg / vial, 2 mg / vial, 5 mg / vial of remifentanil (as remifentanil
hydrochloride)
Lyophilized Powder for Injection
Sterile
Opioid Component to Anesthesia
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Date of Revision:
July 8, 2021
CONTROL NO: 236788
_Remifentanil Hydrochloride for Injection - Product Monograph _
_Page 2 of 43 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
.........................................................................................
13
DRUG INTERACTIONS
..........................................................................................
15
DOSAGE AND
ADMINISTRATION........................................................................
16
OVERDOSAGE
.......................................................................................................
23
ACTION AND CLINICAL
PHARMACOLOGY........................................................
24
STORAGE AND STABILITY
...................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 28
PART II: SCIENTIFIC INFORMATION
.............................................................................
29
PHARMACEUTICAL INFORMATION
....................................................................
29
DETAILED PHARMACOLOGY
...........................