PROLOPA CAP 100-25 CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LEVODOPA; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE)

から入手可能:

HOFFMANN-LA ROCHE LIMITED

ATCコード:

N04BA02

INN（国際名）:

LEVODOPA AND DECARBOXYLASE INHIBITOR

投薬量:

100MG; 25MG

医薬品形態:

CAPSULE

構図:

LEVODOPA 100MG; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 25MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

DOPAMINE PRECURSORS

製品概要:

Active ingredient group (AIG) number: 0211634001; AHFS:

認証ステータス:

MARKETED

承認日:

1977-12-31

製品の特徴

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
...