VIOKACE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PROTEASE; LIPASE; AMYLASE

Sẵn có từ:

NESTLE ENTERPRISES S.A.

Mã ATC:

A09AA02

INN (Tên quốc tế):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Liều dùng:

57100UNIT; 10440UNIT; 56400UNIT

Dạng dược phẩm:

TABLET

Thành phần:

PROTEASE 57100UNIT; LIPASE 10440UNIT; AMYLASE 56400UNIT

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DIGESTANTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-07-02

Đặc tính sản phẩm

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
..............................................