ULTIVA POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Tilgængelig fra:

ABBVIE CORPORATION

ATC-kode:

N01AH06

INN (International Name):

REMIFENTANIL

Dosering:

5MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 5MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

3ML

Recept type:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0133098003; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2013-10-02

Produktets egenskaber

_ _
_ULTIVA_
_®_
_ Product Monograph _
_Page 1 of 30 _
PRODUCT MONOGRAPH
N
ULTIVA
®
(Remifentanil Hydrochloride)
1 mg/vial, 2 mg/vial, 5 mg/vial Injection
Opioid Component to Anesthesia
AbbVie Corporation
8401 Trans Canada Highway
St-Laurent (QC) CANADA H4S 1Z1
Date of Preparation:
November 2, 2012
Date of the Previous Revision:
Date of Revision:
Submission Control No: 158347
NOTE: ULTIVA is a trademark of the Glaxo group of companies, AbbVie
Corporation licensed use
_ _
_ULTIVA_
_®_
_ Product Monograph _
_Page 2 of 30 _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
DETAILED PHARMACOLOGY
.......................................................