REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

N01AH06

INN (nemzetközi neve):

REMIFENTANIL

Adagolás:

2MG

Gyógyszerészeti forma:

POWDER FOR SOLUTION

Összetétel:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

2ML

Recept típusa:

Narcotic (CDSA I)

Terápiás terület:

OPIATE AGONISTS

Termék összefoglaló:

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

Engedélyezési státusz:

MARKETED

Engedély dátuma:

2014-06-05

Termékjellemzők

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