COTAZYM ECS 8 CAPSULE (DELAYED RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LIPASE; AMYLASE; PROTEASE

Disponible desde:

ORGANON CANADA INC.

Código ATC:

A09AA02

Designación común internacional (DCI):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosis:

10800UNIT; 42000UNIT; 45000UNIT

formulario farmacéutico:

CAPSULE (DELAYED RELEASE)

Composición:

LIPASE 10800UNIT; AMYLASE 42000UNIT; PROTEASE 45000UNIT

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

DIGESTANTS

Resumen del producto:

Active ingredient group (AIG) number: 0302964031; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2011-02-09

Ficha técnica

_ _
_Cotazym_
®
_(Pancrelipase)_
_ _
_Page 1 of 13 _
PRODUCT MONOGRAPH
COTAZYM
®
Pancrelipase Preparations
Cotazym
®
Capsules:
10,000 USP units (Lipase activity) / 40,000 USP units (amylase
activity) / 35,000 USP units
(protease activity)
Cotazym
®
ECS 8 Capsules:
10,800 USP units (Lipase activity) / 42,000 USP units (amylase
activity) / 45,000 USP units
(protease activity)
Cotazym
®
ECS 20 Capsules:
25,000 USP units (Lipase activity) / 100,000 USP units (amylase
activity) / 100,000 USP units
(protease activity)
USP
Enzymes–Digestant
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.Organon.ca
Date of Initial Approval:
February 8, 2021
Submission Control No.: 249338
Date of Revision: March 30, 2021
_ _
_Cotazym_
®
_(Pancrelipase)_
_ _
_Page 2 of 13 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
DESCRIPTION
...............................................................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
...............................................................................................3
WARNINGS AND PRECAUTIONS
..............................................................................4
ADVERSE REACTIONS
................................................................................................6
DRUG INTERACTIONS
................................................................................................7
DOSAGE AND ADMINISTRATION
.............................................................................7
OVERDOSAGE
..............................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
............................................................8
STORAGE AND STABILITY
.........