AVA-PRAMIPEXOLE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Dostopno od:

AVANSTRA INC

Koda artikla:

N04BC05

INN (mednarodno ime):

PRAMIPEXOLE

Odmerek:

1.5MG

Farmacevtska oblika:

TABLET

Sestava:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2014-08-21

Lastnosti izdelka

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