País: Canadá
Língua: inglês
Origem: Health Canada
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
PRO DOC LIMITEE
N06DA03
RIVASTIGMINE
1.5MG
CAPSULE
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG
ORAL
100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521001; AHFS:
APPROVED
2013-12-04
_Rivastigmine_ Page 1 of 50 PRODUCT MONOGRAPH PR RIVASTIGMINE (Rivastigmine Hydrogen Tartrate) Capsules, 1.5 mg, 3 mg, 4.5 mg, 6 mg Cholinesterase Inhibitor PRO DOC LTÉE 2925, boul. Industriel Laval, Quebec H7L 3W9 Date of Revision: February 9, 2018 Submission Control No: 213237 _Rivastigmine_ Page 2 of 50 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 ..................................................................................................10 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 ...............................................................................31 PHARMACEUTICAL INFORMATION ..........................................................................31 DETAILED PHARMACOLOGY .....................................................................................39 TOXICOLOGY .......................................................................... Leia o documento completo