ALFENTANIL INJECTION USP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE)

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

N01AH02

INN (Nama Internasional):

ALFENTANIL

Dosis:

500MCG

Bentuk farmasi:

SOLUTION

Komposisi:

ALFENTANIL (ALFENTANIL HYDROCHLORIDE) 500MCG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

2ML*10

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-08-01

Karakteristik produk

_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