MINT-RIVASTIGMINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

N06DA03

INN (Nama Internasional):

RIVASTIGMINE

Dosis:

4.5MG

Bentuk farmasi:

CAPSULE

Komposisi:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

Rute administrasi :

ORAL

Unit dalam paket:

56/100

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-06-19

Karakteristik produk

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