COTAZYM CAPSULE (IMMEDIATE RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LIPASE; AMYLASE; PROTEASE

Dostopno od:

ORGANON CANADA INC.

Koda artikla:

A09AA02

INN (mednarodno ime):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Odmerek:

10000UNIT; 40000UNIT; 35000UNIT

Farmacevtska oblika:

CAPSULE (IMMEDIATE RELEASE)

Sestava:

LIPASE 10000UNIT; AMYLASE 40000UNIT; PROTEASE 35000UNIT

Pot uporabe:

ORAL

Enote v paketu:

100/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

DIGESTANTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0302964032; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-02-09

Lastnosti izdelka

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