AVA-PRAMIPEXOLE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Tersedia dari:

AVANSTRA INC

Kode ATC:

N04BC05

INN (Nama Internasional):

PRAMIPEXOLE

Dosis:

1.5MG

Bentuk farmasi:

TABLET

Komposisi:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0152169004; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2014-08-21

Karakteristik produk

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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
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_Ava-Pramipexole _
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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
..............................................................