País: Canadà
Idioma: anglès
Font: Health Canada
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
TEVA CANADA LIMITED
N06DA03
RIVASTIGMINE
4.5MG
CAPSULE
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG
ORAL
60/100/500
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521003; AHFS:
CANCELLED POST MARKET
2018-05-18
_ _ _ratio-RIVASTIGMINE Capsules _ _Page 1 of 54_ 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 _ _ _ratio-RIVASTIGMINE Capsules _ _Page 2 of 54_ 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 ............................................................................. Llegiu el document complet