REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

N01AH06

Designació comuna internacional (DCI):

REMIFENTANIL

Dosis:

2MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

2ML

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

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

Estat d'Autorització:

MARKETED

Data d'autorització:

2014-06-05

Fitxa tècnica

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_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
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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
..............................................................................................................
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
...................................................................................