RAN-ROPINIROLE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

から入手可能:

RANBAXY PHARMACEUTICALS CANADA INC.

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:

15/18/84

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:

2009-07-22

製品の特徴

_Page 1 of 53_
_Pr_
_RAN_
_™_
_-ROPINIROLE (Ropinirole Hydrochloride Tablets, Mfr. Std.) Product
Monograph _
_ _
PRODUCT MONOGRAPH
PR
RAN
™
-ROPINIROLE
Ropinirole Hydrochloride Tablets, Mfr. Std.
0.25 mg, 0.5 mg, 1.0 mg, 2.0 mg, 5.0 mg ropinirole
Antiparkinsonian Agent / Dopamine Agonist
Ranbaxy Pharmaceuticals Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision: June 29, 2017
Submission Control No: 206743
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
_Page 2 of 53_
_Pr_
_RAN_
_™_
_-ROPINIROLE (Ropinirole Hydrochloride Tablets, Mfr. Std.) Product
Monograph _
_ _
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
..............................................................................................................
8
DRUG INTERACTIONS
.............................................................................................................
21
DOSAGE AND ADMINISTRATION
........................................................................................
23
OVERDOSAGE
...........................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
25
STORAGE AND STABILITY
....................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................