PMS-BUPRENORPHINE-NALOXONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)

Disponible desde:

PHARMASCIENCE INC

Código ATC:

N07BC51

Designación común internacional (DCI):

BUPRENORPHINE, COMBINATIONS

Dosis:

2MG; 0.5MG

formulario farmacéutico:

TABLET

Composición:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5MG

Vía de administración:

SUBLINGUAL

Unidades en paquete:

30

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE PARTIAL AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0252216001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-05-07

Ficha técnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-BUPRENORPHINE-NALOXONE
Buprenorphine and Naloxone Sublingual Tablet
Sublingual Tablet; buprenorphine (as buprenorphine hydrochloride) /
naloxone (as naloxone
hydrochloride dihydrate), 2 mg / 0.5 mg and 8 mg / 2 mg
USP
Partial Opioid Agonist
and
Opioid Antagonist
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
May 7, 2014
Date of Revision:
September 25, 2023
Submission Control No:
_pms-BUPRENORPHINE-NALOXONE Product Monograph _
_ _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
7 WARNINGS AND PRECAUTIONS, Gastro-intestinal
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX................................................................ 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.1
Dosing Considerations
..............................................................