PHEBURANE GRANULES

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

SODIUM PHENYLBUTYRATE

可用日期:

MEDUNIK CANADA

ATC代码:

A16AX03

INN（国际名称）:

SODIUM PHENYLBUTYRATE

剂量:

483MG

药物剂型:

GRANULES

组成:

SODIUM PHENYLBUTYRATE 483MG

给药途径:

ORAL

每包单位数:

174G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0156470001; AHFS:

授权状态:

APPROVED

授权日期:

2015-01-26

产品特点

_ _
_Pheburane Product Monograph _
_Page 1 of 24 _
PRODUCT MONOGRAPH
Pr
PHEBURANE
®
Sodium phenylbutyrate granules
483 mg per gram of granules
ATC Code: A16AX03
Alimentary tract and metabolism product
Médunik Canada
950, boul. Michèle-Bohec
Blainville, Québec
Canada, J7C 5E2
www.medunikcanada.com
Date of Preparation:
June 13, 2014
Date of Revision:
December 6, 2017
Submission Control No: 209765
_ _
_Pheburane Product Monograph _
_Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
......................