PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DICLOFENAC SODIUM; MISOPROSTOL

Disponible desde:

PHARMASCIENCE INC

Código ATC:

M01AB55

Designación común internacional (DCI):

DICLOFENAC, COMBINATIONS

Dosis:

50MG; 200MCG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0222885003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-10-01

Ficha técnica

PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC-MISOPROSTOL
Diclofenac Sodium and Misoprostol
Enteric-Coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
75 mg diclofenac/200 mcg misoprostol
NSAID WITH A MUCOSAL PROTECTIVE AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 1, 2022
Submission
Control No: 263143
_ _
_pms-DICLOFENAC-MISOPROSTOL Product Monograph Page 2 of 55_
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............................................................................................
22
DOSAGE AND
ADMINISTRATION.........................................................................
26
OVERDOSAGE
.........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND
STABILITY....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 31
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL
INFORMATION.....................................................................
32
CLINICAL TRIALS
...................................................................................................
34
DE