RATIO-RIVASTIGMINE CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

N06DA03

INN (International ime):

RIVASTIGMINE

Doziranje:

4.5MG

Farmaceutski oblik:

CAPSULE

Sastav:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

Administracija rute:

ORAL

Jedinice u paketu:

60/100/500

Tip recepta:

Prescription

Područje terapije:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2018-05-18

Svojstava lijeka

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PRODUCT MONOGRAPH
Pr
ratio-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg and 6 mg rivastigmine
(as rivastigmine hydrogen tartrate)
Capsules
Cholinesterase Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
November 08, 2016
Submission Control No: 199189
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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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
.............................................................................