MYLAN-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

N06DA04

INN (Nama Antarabangsa):

GALANTAMINE

Dos:

16MG

Borang farmaseutikal:

CAPSULE (EXTENDED RELEASE)

Komposisi:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0144660004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2011-11-12

Ciri produk

Page 1 of 55
PRODUCT MONOGRAPH
Pr
MYLAN-GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 13, 2017
Submission Control No: 204535
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
...............................................