VIOKACE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

LIPASE; PROTEASE; AMYLASE

Fáanlegur frá:

NESTLE ENTERPRISES S.A.

ATC númer:

A09AA02

INN (Alþjóðlegt nafn):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Skammtar:

20880UNIT; 112500UNIT; 113400UNIT

Lyfjaform:

TABLET

Samsetning:

LIPASE 20880UNIT; PROTEASE 112500UNIT; AMYLASE 113400UNIT

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

DIGESTANTS

Vörulýsing:

Active ingredient group (AIG) number: 0302964043; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-07-02

Vara einkenni

IMPORTANT: PLEASE READ
_ _
_VIOKACE_
_TM_
_ – Pancrelipase Tablets _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_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
_ _
_VIOKACE_
_TM_
_ – Pancrelipase Tablets _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_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
..............................................