AURO-PRAMIPEXOLE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

可用日期:

AURO PHARMA INC

ATC代码:

N04BC05

INN（国际名称）:

PRAMIPEXOLE

剂量:

1MG

药物剂型:

TABLET

组成:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

產品總結:

Active ingredient group (AIG) number: 0152169003; AHFS:

授权状态:

APPROVED

授权日期:

2014-04-29

产品特点

Page 1 of 56
PRODUCT MONOGRAPH
PR
AURO-PRAMIPEXOLE
Pramipexole Dihydrochloride Tablets
0.25 mg, 0.5 mg, 1 mg & 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian agent / Dopamine Agonist
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
January 27, 2021.
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No.: 243774
Page 2 of 56
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
.....................................................................................................10
DRUG INTERACTIONS
...................................................................................................19
DOSAGE AND ADMINISTRATION
...............................................................................21
OVERDOSAGE
.................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY..............................................................25
STORAGE AND STABILITY
...........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
........................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................29
PART II: SCIENTIFIC INFORMATION
.............................................................................31
PHARMACEUTICAL INFORMATION
...........................................................................31
CLINICAL TRIALS
.......................