AURO-PRAMIPEXOLE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Dostopno od:

AURO PHARMA INC

Koda artikla:

N04BC05

INN (mednarodno ime):

PRAMIPEXOLE

Odmerek:

0.125MG

Farmacevtska oblika:

TABLET

Sestava:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.125MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0152169005; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-11-29

Lastnosti izdelka

Page 1 of 45
PRODUCT MONOGRAPH
PR
AURO-PRAMIPEXOLE
Pramipexole Dihydrochloride Tablets
0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg & 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian agent / Dopamine Agonist
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Submission control No.: 165933
Date of Preparation:
April 23, 2014
Page 2 of 45
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
.....................................................................................................9
DRUG INTERACTIONS
...................................................................................................14
DOSAGE AND ADMINISTRATION
...............................................................................17
OVERDOSAGE
.................................................................................................................19
ACTION AND CLINICAL
PHARMACOLOGY..............................................................19
STORAGE AND STABILITY
...........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
........................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................23
PART II: SCIENTIFIC INFORMATION
.............................................................................25
PHARMACEUTICAL INFORMATION
...........................................................................25
CLINICAL TRIALS
...................