ULTIVA POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Dostupné s:

ABBVIE CORPORATION

ATC kód:

N01AH06

INN (Mezinárodní Name):

REMIFENTANIL

Dávkování:

5MG

Léková forma:

POWDER FOR SOLUTION

Složení:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 5MG

Podání:

INTRAVENOUS

Jednotky v balení:

3ML

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2013-10-02

Charakteristika produktu

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