PRIVA-TRAMADOL/ACET TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Disponible desde:

PHARMAPAR INC

Código ATC:

N02AJ13

Designación común internacional (DCI):

TRAMADOL AND PARACETAMOL

Dosis:

325MG; 37.5MG

formulario farmacéutico:

TABLET

Composición:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Vía de administración:

ORAL

Unidades en paquete:

60/100

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0250601001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-10-13

Ficha técnica

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_Priva-TRAMADOL/ACET_
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRIVA-TRAMADOL/ACET
Acetaminophen and Tramadol Hydrochloride Tablets, Pharmapar Std.
37.5 mg Tramadol Hydrochloride/325 mg Acetaminophen
Centrally Acting Analgesic
Pharmapar Inc.
Date of revision:
1565, boul. Lionel-Boulet
January 30, 2020
Varennes, QC
J3X1P7
Control # 234260
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_Priva-TRAMADOL/ACET_
Page 2 of 68
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 31
STORAGE AND STABILITY
.........................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
......................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 38
PART II: SCIENTIFIC INFORMATION
...............................................................................
40
PHARMACEUTICAL INFORMATION
.........................................................................
40
CLINICAL TRIALS
...................................................................................