MYLAN-PRAMIPEXOLE TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
03-11-2015
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Aktivna sestavina:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Dostopno od:
MYLAN PHARMACEUTICALS ULC
Koda artikla:
N04BC05
INN (mednarodno ime):
PRAMIPEXOLE
Odmerek:
0.5MG
Farmacevtska oblika:
TABLET
Sestava:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5MG
Pot uporabe:
ORAL
Enote v paketu:
90
Tip zastaranja:
Prescription
Terapevtsko območje:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0152169002; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2017-05-08
Lastnosti izdelka
Page 1 of 45
PRODUCT MONOGRAPH
PR
MYLAN-PRAMIPEXOLE
Pramipexole Dihydrochloride Tablet
0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian Agent / Dopamine Agonist
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control No.: 188569
Date of Revision: November 3, 2015
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
..............................................................................................................
10
DRUG
INTERACTIONS
...............................................................................................................
15
DOSAGE
AND
ADMINISTRATION
..........................................................................................
17
OVERDOSAGE
..............................................................................................................................
19
ACTION
AND
CLINICAL
PHARMACOLOGY
........................................................................
20
STORAGE
AND
STABILITY
......................................................................................................
23
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
........................................................ 24
PART II: SCIENTIFIC INFORMATION ...................................................................................
25
PHARMACEUTICAL
INFORMATION
.............................................................................
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