MINT-RIVASTIGMINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Disponible depuis:

MINT PHARMACEUTICALS INC

Code ATC:

N06DA03

DCI (Dénomination commune internationale):

RIVASTIGMINE

Dosage:

1.5MG

forme pharmaceutique:

CAPSULE

Composition:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

Mode d'administration:

ORAL

Unités en paquet:

56

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-06-19

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
MINT-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg, 6 mg Rivastigmine
(supplied as Rivastigmine Hydrogen Tartrate)
Capsules
Mint Standard
Cholinesterase Inhibitor
Mint Pharmaceuticals Inc. Date of Revision: December 22, 2016
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 200803
2
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
............................................................................................
25
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
......................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 32
PART II: SCIENTIFIC INFORMATION
..........................................................................
33
PHARMACEUTICAL INFORMATION
........................................................................
33
CLINICAL TRIALS
.....................................................................................................
34
DETAILED PHARMACOLOGY
..........................................................................