REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

N01AH06

INN (Mezinárodní Name):

REMIFENTANIL

Dávkování:

2MG

Léková forma:

POWDER FOR SOLUTION

Složení:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Podání:

INTRAVENOUS

Jednotky v balení:

2ML

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

MARKETED

Datum autorizace:

2014-06-05

Charakteristika produktu

_ _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
REMIFENTANIL FOR INJECTION
1 mg/vial, 2 mg/vial of remifentanil
Lyophilized Powder for Injection
Sterile
Opioid Component to Anesthesia
Teva Canada Limited
Date of Revision:
30 Novopharm Court
January 2, 2019
Toronto, Ontario
M1B 2K9
Control Number: 221336
_ _
_ _
_Page 2 of 42_
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
.............................................................................................................
14
DRUG INTERACTIONS
.............................................................................................................
16
DOSAGE AND ADMINISTRATION
.........................................................................................
17
OVERDOSAGE
...........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
24
STORAGE AND STABILITY
.....................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 28
PART II: SCIENTIFIC INFORMATION
...............................................................................
29
PHARMACEUTICAL INFORMATION
...................................................................................