AVA-PRAMIPEXOLE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Boleh didapati daripada:

AVANSTRA INC

Kod ATC:

N04BC05

INN (Nama Antarabangsa):

PRAMIPEXOLE

Dos:

1.0MG

Borang farmaseutikal:

TABLET

Komposisi:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2014-08-21

Ciri produk

_ _
_Ava-Pramipexole _
_Page 1 of 42_
PRODUCT MONOGRAPH
PR AVA-PRAMIPEXOLE
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
0.25 MG, 0.5 MG, 1.0 MG AND 1.5 MG
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
ANTIPARKINSONIAN AGENT/DOPAMINE AGONIST
Avanstra Inc.
Date of Preparation: September 12, 2011
10761-25th NE, Suite 110, Building B,
Calgary, Alberta, Canada
T2C 3C2
Submission Control No: 144865
_ _
_Ava-Pramipexole _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY
PRODUCT
INFORMATION
.................................................................................3
INDICATION
AND
CLINICAL
USE
.........................................................................................3
CONTRAINDICATIONS............................................................................................................3
WARNINGS
AND
PRECAUTIONS...........................................................................................4
ADVERSE
REACTIONS
............................................................................................................9
DRUG
INTERACTIONS...........................................................................................................14
DOSAGE
AND
ADMINISTRATION.......................................................................................16
OVERDOSAGE
.........................................................................................................................18
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................18
STORAGE
AND
STABILITY...................................................................................................21
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................................22
PART II: SCIENTIFIC INFORMATION
..............................................................