DOM-RIVASTIGMINE CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Pieejams no:

DOMINION PHARMACAL

ATĶ kods:

N06DA03

SNN (starptautisko nepatentēto nosaukumu):

RIVASTIGMINE

Deva:

3.0MG

Zāļu forma:

CAPSULE

Kompozīcija:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 3.0MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0140521002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2009-09-02

Produkta apraksts

PRODUCT MONOGRAPH
PR
DOM-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules, House Standard
1.5 mg, 3 mg, 4.5 mg and 6 mg of Rivastigmine
(as Rivastigmine Hydrogen Tartrate)
Cholinestesterase Inhibitor
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision :
April 20, 2016
SUBMISSION CONTROL NO: 193451
_ _
_Dom-RIVASTIGMINE Product Monograph _
_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
................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
.......................................................................................