MYLAN-RIVASTIGMINE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Mevcut itibaren:

MYLAN PHARMACEUTICALS ULC

ATC kodu:

N06DA03

INN (International Adı):

RIVASTIGMINE

Doz:

3MG

Farmasötik formu:

CAPSULE

Kompozisyon:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 3MG

Uygulama yolu:

ORAL

Paketteki üniteler:

14/100

Reçete türü:

Prescription

Terapötik alanı:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-11-02

Ürün özellikleri

_Page 1 of 56 _
PRODUCT MONOGRAPH
PR
MYLAN-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules
1.5 mg, 3 mg, 4.5 mg and 6 mg Rivastigmine
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control Number: 184285
_Page 2 of 56 _
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
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
33
PHARMACEUTICAL INFORMATION
.........................................................................
33
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
................................................