REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

N01AH06

INN (International namn):

REMIFENTANIL

Dos:

2MG

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

100

Receptbelagda typ:

Narcotic (CDSA I)

Terapiområde:

OPIATE AGONISTS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED PRE MARKET

Tillstånd datum:

2021-03-22

Produktens egenskaper

_ _
_Remifentanil for Injection _
_Page 1 of 44_
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
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC J4B 1E6
Date of Revision:
November 27, 2018
Submission Control No: 221334
_ _
_Remifentanil for Injection _
_Page 2 of 44_
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
..............................................................................................................
15
DRUG INTERACTIONS
..............................................................................................................
17
DOSAGE AND ADMINISTRATION
..........................................................................................
18
OVERDOSAGE
............................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
25
STORAGE AND STABILITY
......................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 30
PART II: SCIENTIFIC INFORMATION
............................................................................................
32
PHARMACEUTICAL