RATIO-RIVASTIGMINE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

N06DA03

INN（国際名）:

RIVASTIGMINE

投薬量:

4.5MG

医薬品形態:

CAPSULE

構図:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

投与経路:

ORAL

パッケージ内のユニット:

60/100/500

処方タイプ:

Prescription

治療領域:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

製品概要:

Active ingredient group (AIG) number: 0140521003; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2018-05-18

製品の特徴

_ _
_ratio-RIVASTIGMINE Capsules _
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PRODUCT MONOGRAPH
Pr
ratio-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg and 6 mg rivastigmine
(as rivastigmine hydrogen tartrate)
Capsules
Cholinesterase Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
November 08, 2016
Submission Control No: 199189
_ _
_ratio-RIVASTIGMINE Capsules _
_Page 2 of 54_
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
.............................................................................