MYLAN-RIVASTIGMINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N06DA03

INN (Nama Internasional):

RIVASTIGMINE

Dosis:

1.5MG

Bentuk farmasi:

CAPSULE

Komposisi:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

Rute administrasi :

ORAL

Unit dalam paket:

14/100

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-11-02

Karakteristik produk

_Page 1 of 56 _
PRODUCT MONOGRAPH
PR
MYLAN-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules
1.5 mg, 3 mg, 4.5 mg and 6 mg Rivastigmine
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control Number: 184285
_Page 2 of 56 _
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
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
33
PHARMACEUTICAL INFORMATION
.........................................................................
33
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
................................................