RATIO-RIVASTIGMINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Tersedia dari:

TEVA CANADA LIMITED

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:

60/100/500

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-05-18

Karakteristik produk

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