Riik: Kanada
keel: inglise
Allikas: Health Canada
DONEPEZIL HYDROCHLORIDE
JAMP PHARMA CORPORATION
N06DA02
DONEPEZIL
5MG
TABLET
DONEPEZIL HYDROCHLORIDE 5MG
ORAL
28/30/250
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0131548001; AHFS:
APPROVED
2013-12-27
JAMP-DONEPEZIL TABLETS (donepezil hydrochloride) Product Monograph Page 1 of 51 PRODUCT MONOGRAPH PR JAMP-DONEPEZIL TABLETS (donepezil hydrochloride) Tablets 5 and 10 mg CHOLINESTERASE INHIBITOR JAMP PHARMA CORPORATION 1380-203 NEWTON STREET BOUCHERVILLE, QUEBEC J4B 5H2 DATE OF REVISION: MARCH 12, 2015 Submission Control No: 182041 JAMP-DONEPEZIL TABLETS (donepezil hydrochloride) Product Monograph Page 2 of 51 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................3 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................22 PHARMACEUTICAL INFORMATION ..........................................................................22 CLINICAL TRIALS ......................................................................... Lugege kogu dokumenti