PMS-GALANTAMINE TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Disponibbli minn:

PHARMASCIENCE INC

Kodiċi ATC:

N06DA04

INN (Isem Internazzjonali):

GALANTAMINE

Dożaġġ:

12MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 12MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0144660003; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2010-01-26

Karatteristiċi tal-prodott

Page 1 of 53
PRODUCT MONOGRAPH
Pr
PMS-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite #100
Montreal, Quebec
H4P 2T4
Control #
106278
Date of Preparation:
January 22, 2010
Page 2 of 53
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
..........................................................................................8
DRUG INTERACTIONS
.........................................................................................14
DOSAGE AND ADMINISTRATION
.....................................................................16
OVERDOSAGE
.......................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
...................................................19
STORAGE AND STABILITY
................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
........................................................................................................35
REFEREN