MINT-RIVASTIGMINE CAPSULE

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

มีจำหน่ายจาก:

MINT PHARMACEUTICALS INC

รหัส ATC:

N06DA03

INN (ชื่อสากล):

RIVASTIGMINE

ปริมาณ:

1.5MG

แบบฟอร์มเภสัชกรรม:

CAPSULE

องค์ประกอบ:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

56

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

สรุปสินค้า:

Active ingredient group (AIG) number: 0140521001; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2017-06-19

สรุปลักษณะสินค้า

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
..........................................................................