ALFENTANIL INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N01AH02

INN (International Name):

ALFENTANIL

Dosage:

500MCG

Pharmaceutical form:

SOLUTION

Composition:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE) 500MCG

Administration route:

INTRAVENOUS

Units in package:

2ML*10

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0119704002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

_Alfentanil Injection USP _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ALFENTANIL INJECTION USP
Alfentanil Hydrochloride
Solution for Injection, 500 mcg/mL, Intravenous
USP
Opioid Analgesic
Adjunct to Anesthesia
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
March 8, 2018
Submission Control No: 204960
_ _
_Alfentanil Injection USP _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
Transfer into new template
Dec, 2018
Include information for Opioid Class Labelling
Dec, 2018
TABLE OF CONTENTS
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
1
INDICATIONS
...................................................................................................................
3
1.1
Pediatrics
.................................................................................................................
3
1.2
Geriatrics
.................................................................................................................
3
2
CONTRAINDICATIONS
...................................................................................................
3
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.3
Administration
..........................................................................................................
9
5
OVERDOSAGE
................................................................................................................
9
6
DOSAGE FORMS, STRENGTHS, COMPOSITION A