JAMP PRUCALOPRIDE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)

Disponible desde:

JAMP PHARMA CORPORATION

Código ATC:

A06AX05

Designación común internacional (DCI):

PRUCALOPRIDE

Dosis:

1MG

formulario farmacéutico:

TABLET

Composición:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 1MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS GI DRUGS

Resumen del producto:

Active ingredient group (AIG) number: 0153049001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2019-12-09

Ficha técnica

_ JAMP PRUCALOPRIDE_
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
JAMP PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg prucalopride as prucalopride succinate
Prokinetic agent
Jamp Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec, J4B 5H3
Date of Preparation:
October 28, 2019
Submission Control No: 226302
_ JAMP PRUCALOPRIDE_
_Page 2 of 37_
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
........................................................................................................
6
DRUG INTERACTIONS
......................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
11
OVERDOSAGE
....................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 12
STORAGE AND STABILITY
..............................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
............................................................................
15
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 16
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
....................................................................