PROLOPA CAP 100-25 CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
02-08-2019
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Aktiv ingrediens:
LEVODOPA; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE)
Tilgjengelig fra:
HOFFMANN-LA ROCHE LIMITED
ATC-kode:
N04BA02
INN (International Name):
LEVODOPA AND DECARBOXYLASE INHIBITOR
Dosering :
100MG; 25MG
Legemiddelform:
CAPSULE
Sammensetning:
LEVODOPA 100MG; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 25MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
DOPAMINE PRECURSORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0211634001; AHFS:
Autorisasjon status:
MARKETED
Autorisasjon dato:
1977-12-31
Preparatomtale
PRODUCT MONOGRAPH
PR
PROLOPA
®
levodopa and benserazide capsules
50 mg - 12.5 mg, 100 mg - 25 mg, 200 mg - 50mg
Pharmaceutical standard: professed
Antiparkinson Agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Revision:
August 2, 2019
Submission Control No: 228354
PROLOPA
®
is a registered trade-mark of Hoffmann-La Roche Limited
©
Copyright 1977 – 2019, Hoffmann-La Roche Limited
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
ADVERSE REACTIONS
.................................................................................................
9
DRUG INTERACTIONS
................................................................................................
11
DOSAGE AND ADMINISTRATION
............................................................................
13
OVERDOSAGE
..............................................................................................................
15
STORAGE AND
STABILITY........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.......................................................................
20
DETAILED PHARMACOLOGY
...................................................................................
20
TOXICOLOGY
...............................................................................................................
23
REFERENCES
...
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