COTAZYM ECS 8 CAPSULE (DELAYED RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LIPASE; AMYLASE; PROTEASE

Disponibbli minn:

ORGANON CANADA INC.

Kodiċi ATC:

A09AA02

INN (Isem Internazzjonali):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dożaġġ:

10800UNIT; 42000UNIT; 45000UNIT

Għamla farmaċewtika:

CAPSULE (DELAYED RELEASE)

Kompożizzjoni:

LIPASE 10800UNIT; AMYLASE 42000UNIT; PROTEASE 45000UNIT

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

DIGESTANTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2011-02-09

Karatteristiċi tal-prodott

_ _
_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
.........