MYLAN-RIVASTIGMINE PATCH 10

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

RIVASTIGMINE

Disponible des:

MYLAN PHARMACEUTICALS ULC

Codi ATC:

N06DA03

Designació comuna internacional (DCI):

RIVASTIGMINE

Dosis:

9.5MG

formulario farmacéutico:

PATCH

Composición:

RIVASTIGMINE 9.5MG

Vía de administración:

TRANSDERMAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0140521008; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-12-02

Fitxa tècnica

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_Page 1 of 61_
PRODUCT MONOGRAPH
PR
MYLAN-RIVASTIGMINE PATCH 5
Rivastigmine Transdermal Patch
Each patch of 5 cm
2
contains 9 mg rivastigmine base, _in vivo _release rate of 4.6 mg/24
h.
PR
MYLAN-RIVASTIGMINE PATCH 10
Rivastigmine Transdermal Patch
Each patch of 10 cm
2
contains 18 mg rivastigmine base, _in vivo _release rate of 9.5 mg/24
h.
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
September 30, 2016
Submission Control No: 167242, 184616, 198467
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
......................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
....................................