MINT-RIVASTIGMINE CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
22-12-2016

유효 성분:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

제공처:

MINT PHARMACEUTICALS INC

ATC 코드:

N06DA03

INN (International Name):

RIVASTIGMINE

복용량:

4.5MG

약제 형태:

CAPSULE

구성:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

관리 경로:

ORAL

패키지 단위:

56/100

처방전 유형:

Prescription

치료 영역:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-06-19

제품 특성 요약

                                PRODUCT MONOGRAPH
PR
MINT-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg, 6 mg Rivastigmine
(supplied as Rivastigmine Hydrogen Tartrate)
Capsules
Mint Standard
Cholinesterase Inhibitor
Mint Pharmaceuticals Inc. Date of Revision: December 22, 2016
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 200803
2
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
............................................................................................
11
DRUG INTERACTIONS
............................................................................................
25
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
......................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 32
PART II: SCIENTIFIC INFORMATION
..........................................................................
33
PHARMACEUTICAL INFORMATION
........................................................................
33
CLINICAL TRIALS
.....................................................................................................
34
DETAILED PHARMACOLOGY
..........................................................................
                                
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