VIOKACE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PROTEASE; LIPASE; AMYLASE

Available from:

NESTLE ENTERPRISES S.A.

ATC code:

A09AA02

INN (International Name):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosage:

57100UNIT; 10440UNIT; 56400UNIT

Pharmaceutical form:

TABLET

Composition:

PROTEASE 57100UNIT; LIPASE 10440UNIT; AMYLASE 56400UNIT

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

DIGESTANTS

Product summary:

Active ingredient group (AIG) number: 0302964042; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-07-02

Summary of Product characteristics

IMPORTANT: PLEASE READ
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_VIOKACE_
_TM_
_ – Pancrelipase Tablets _
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_Page 1 of 17_
PRODUCT MONOGRAPH
PR
VIOKACE
TM
Pancrelipase tablets
10,440 USP and 20,880 USP units of lipase
USP
Pancreatic enzymes
A09AA02
Nestlé Enterprises S.A.
12, rue Entre-deux-Villes
1800 Vevey, Switzerland
Distributed by:
Accelera Pharma Canada Inc. Mississauga, ON, L5L 5Z9
Date of Initial Approval:
March 25, 2015
Date of Revision:
July 3, 2020
Submission Control No: 239610
IMPORTANT: PLEASE READ
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_VIOKACE_
_TM_
_ – Pancrelipase Tablets _
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_Page 2 of 17_
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
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
6
DOSAGE AND ADMINISTRATION
...............................................................................
7
OVERDOSAGE
..................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 8
STORAGE AND STABILITY
...........................................................................................
8
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................