MINT-PREGABALIN CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PREGABALIN

Disponible desde:

MINT PHARMACEUTICALS INC

Código ATC:

N02BF02

Designación común internacional (DCI):

PREGABALIN

Dosis:

50MG

formulario farmacéutico:

CAPSULE

Composición:

PREGABALIN 50MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0151121002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-05-02

Ficha técnica

______________________________________________________________________________
_Mint-Pregabalin Product Monograph _
1 of 64
_ _
PRODUCT MONOGRAPH
PR
MINT-PREGABALIN
Pregabalin Capsules
Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300
mg
ANALGESIC AGENT
Mint Pharmaceuticals Inc.
6575 Davand Dr
Mississauga, Ontario, Canada
L5T 2M3
SUBMISSION CONTROL NUMBER: 255444
DATE OF PREPARATION:
September 22, 2021
______________________________________________________________________________
_Mint-Pregabalin Product Monograph _
2 of 64
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT
INFORMATION........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS...................................................................................................4
WARNINGS AND PRECAUTIONS
.................................................................................4
ADVERSE
REACTIONS..................................................................................................15
DRUG
INTERACTIONS..................................................................................................34
DOSAGE AND ADMINISTRATION
.............................................................................36
OVERDOSAGE................................................................................................................39
ACTION AND CLINICAL
PHARMACOLOGY............................................................40
STORAGE AND
STABILITY..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................43
PART II: SCIENTIFIC
INFORMATION................................................................................45
PHARMACEUTICAL
INFORMATION.......................................