TEVA-ROPINIROLE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
22-05-2020
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有効成分:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
から入手可能:
TEVA CANADA LIMITED
ATCコード:
N04BC04
INN（国際名）:
ROPINIROLE
投薬量:
0.25MG
医薬品形態:
TABLET
構図:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25MG
投与経路:
ORAL
パッケージ内のユニット:
15G/50G
処方タイプ:
Prescription
治療領域:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
製品概要:
Active ingredient group (AIG) number: 0132618001; AHFS:
認証ステータス:
APPROVED
承認日:
2019-12-02
製品の特徴
_ _
_TEVA-ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _
_Page 1 of 53_
PRODUCT MONOGRAPH
Pr
TEVA-ROPINIROLE
Ropinirole Tablets, USP
0.25 mg, 1 mg, 2 mg & 5 mg ropinirole (as ropinirole hydrochloride)
Antiparkinsonian Agent / Dopamine Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario, M1B 2K9
Date of Revision:
May 19, 2020
Submission Control No: 236456
_ _
_TEVA- ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _
_Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
...........................................
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