TALWIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PENTAZOCINE (PENTAZOCINE HYDROCHLORIDE)

Disponible desde:

SANOFI-AVENTIS CANADA INC

Código ATC:

N02AD01

Designación común internacional (DCI):

PENTAZOCINE

Dosis:

50MG

formulario farmacéutico:

TABLET

Composición:

PENTAZOCINE (PENTAZOCINE HYDROCHLORIDE) 50MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE PARTIAL AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0108852002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-02-19

Ficha técnica

_Page 1 of 32 _
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
Ⓝ
TALWIN
®
pentazocine hydrochloride
Tablets, 50 mg
Narcotic Analgesic
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
May 22, 2018
Submission Control No: 213122
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
PART III: CONSUMER MEDICATION INFORMATION
..................................................24
_Page 3 of 32 _
Ⓝ
TALWIN
®
pentazocine hydrochloride tablets
PART I: HEALTH PROFESSIONAL INFORMATI