ALFENTANIL INJECTION USP SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE)

Saadav alates:

SANDOZ CANADA INCORPORATED

ATC kood:

N01AH02

INN (Rahvusvaheline Nimetus):

ALFENTANIL

Annus:

500MCG

Ravimvorm:

SOLUTION

Koostis:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE) 500MCG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

2ML*10

Retsepti tüüp:

Narcotic (CDSA I)

Terapeutiline ala:

OPIATE AGONISTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2019-08-01

Toote omadused

_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