PMS-RIVASTIGMINE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

N06DA03

INN (International Adı):

RIVASTIGMINE

Doz:

1.5MG

Farmasötik formu:

CAPSULE

Kompozisyon:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

60/100

Reçete türü:

Prescription

Terapötik alanı:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0140521001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2009-07-20

Ürün özellikleri

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
....................................................................................................