PMS-GALANTAMINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

N06DA04

SNN (starptautisko nepatentēto nosaukumu):

GALANTAMINE

Deva:

4MG

Zāļu forma:

TABLET

Kompozīcija:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 4MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0144660001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-01-26

Produkta apraksts

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