Țară: Canada
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Sursă: Health Canada
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
DOMINION PHARMACAL
N06DA03
RIVASTIGMINE
4.5MG
CAPSULE
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG
ORAL
100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521003; AHFS:
APPROVED
2009-09-02
PRODUCT MONOGRAPH PR DOM-RIVASTIGMINE Rivastigmine Hydrogen Tartrate Capsules, House Standard 1.5 mg, 3 mg, 4.5 mg and 6 mg of Rivastigmine (as Rivastigmine Hydrogen Tartrate) Cholinestesterase Inhibitor DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 Date of Revision : April 20, 2016 SUBMISSION CONTROL NO: 193451 _ _ _Dom-RIVASTIGMINE Product Monograph _ _Page 2 of 53_ 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 ..................................................................................................22 DOSAGE AND ADMINISTRATION ..............................................................................24 OVERDOSAGE ................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ............................................................26 STORAGE AND STABILITY ..........................................................................................29 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................29 PART II: SCIENTIFIC INFORMATION ...............................................................................30 PHARMACEUTICAL INFORMATION ..........................................................................30 CLINICAL TRIALS ....................................................................................... Citiți documentul complet