TEVA-BUPRENORPHINE/NALOXONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

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

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

N07BC51

Designación común internacional (DCI):

BUPRENORPHINE, COMBINATIONS

Dosis:

8MG; 2MG

formulario farmacéutico:

TABLET

Composición:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2MG

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: 0252216002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2019-12-17

Ficha técnica

TEVA-BUPRENORPHINE/NALOXONE
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_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N TEVA-BUPRENORPHINE/NALOXONE
Buprenorphine and Naloxone Sublingual Tablets
Tablets, Buprenorphine (as Buprenorphine Hydrochloride) and Naloxone
(as
Naloxone Hydrochloride Dihydrate),
2 mg/0.5 mg and 8 mg/2 mg, sublingual
Teva Standard
Partial Opioid Agonist
and
Opioid Antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
April 18, 2016
Date of Revision:
January 25, 2022
Submission Control No.: 254725
_ _
TEVA-BUPRENORPHINE/NALOXONE
_ _
_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
3 Serious Warning and Precautions
01/2022
4 Dosage and Administration
01/2022
7 Warning and Precautions
01/2022
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
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4
1.1
P
EDIATRICS
....................................................................................................................................................
4
1.2
G
ERIATRICS
...................................................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
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