COTAZYM ECS 20 CAPSULE (DELAYED RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

LIPASE; AMYLASE; PROTEASE

Prieinama:

ORGANON CANADA INC.

ATC kodas:

A09AA02

INN (Tarptautinis Pavadinimas):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dozė:

25000UNIT; 100000UNIT; 100000UNIT

Vaisto forma:

CAPSULE (DELAYED RELEASE)

Sudėtis:

LIPASE 25000UNIT; AMYLASE 100000UNIT; PROTEASE 100000UNIT

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/250

Recepto tipas:

Prescription

Gydymo sritis:

DIGESTANTS

Produkto santrauka:

Active ingredient group (AIG) number: 0302964026; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2011-02-09

Prekės savybės

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