PMS-RIVASTIGMINE CAPSULE

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Dostupné z:

PHARMASCIENCE INC

ATC kód:

N06DA03

INN (Medzinárodný Name):

RIVASTIGMINE

Dávkovanie:

4.5MG

Forma lieku:

CAPSULE

Zloženie:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

Spôsob podávania:

ORAL

Počet v balení:

250ML

Typ predpisu:

Prescription

Terapeutické oblasti:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2009-07-20

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
PMS-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
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision :
November 1, 2016
www.pharmascience.com
SUBMISSION CONTROL NO: 199174
_ _
_pms-RIVASTIGMINE Product Monograph _
_Page 2 of 52_
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
..............................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................
24
OVERDOSAGE
...........................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 27
STORAGE AND STABILITY
......................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 29
PART II: SCIENTIFIC INFORMATION
...........................................................................
31
PHARMACEUTICAL INFORMATION
......................................................................
31
CLINICAL TRIALS
....................................................................................................