PROCYSBI CAPSULE (DELAYED RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CYSTEAMINE (CYSTEAMINE BITARTRATE)

可用日期:

HORIZON THERAPEUTICS IRELAND DAC

ATC代码:

A16AA04

INN（国际名称）:

MERCAPTAMINE

剂量:

25MG

药物剂型:

CAPSULE (DELAYED RELEASE)

组成:

CYSTEAMINE (CYSTEAMINE BITARTRATE) 25MG

给药途径:

ORAL

每包单位数:

50

处方类型:

Prescription

治疗领域:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0159170001; AHFS:

授权状态:

APPROVED

授权日期:

2017-06-13

产品特点

_ _
_PROCYSBI_
_®_
_ cysteamine delayed-release capsules _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROCYSBI
®
Cysteamine delayed-release capsules
25 mg and 75 mg cysteamine (as cysteamine bitartrate, also called
mercaptamine bitartrate)
ATC code: A16AA04
Amino Acids and Derivatives
Horizon Therapeutics Ireland DAC
Connaught House, 1
st
Floor
1 Burlington
Road
Dublin 4, D04 C5Y6
Ireland
Imported and distributed by:
Horizon Therapeutics Canada
9131 Keele St., Unit 4A
Vaughan, Ontario L4K 0G7
Canada
Date of Revision:
July 22, 2021
Submission
Control No: 240671
_ _
_PROCYSBI_
_®_
_ cysteamine delayed-release capsules _
_Page 2 of 38_
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..............................................................................................7
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
.........................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
18
STORAGE AND STABILITY
....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 22
PART II: SCIENTIFIC INFORMATION
...................................................................