MYLAN-RIVASTIGMINE CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Disponibbli minn:

MYLAN PHARMACEUTICALS ULC

Kodiċi ATC:

N06DA03

INN (Isem Internazzjonali):

RIVASTIGMINE

Dożaġġ:

4.5MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

14/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2016-11-02

Karatteristiċi tal-prodott

_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
................................................