REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Disponibbli minn:

SANDOZ CANADA INCORPORATED

Kodiċi ATC:

N01AH06

INN (Isem Internazzjonali):

REMIFENTANIL

Dożaġġ:

1MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 1MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Narcotic (CDSA I)

Żona terapewtika:

OPIATE AGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0133098001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2021-03-22

Karatteristiċi tal-prodott

_ _
_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