DONEPEZIL HYDROCHLORIDE TABLETS USP

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Διαθέσιμο από:

DR REDDY'S LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

N06DA02

INN (Διεθνής Όνομα):

DONEPEZIL

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

7/14/30/90/500/1000/9000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131548001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-12-27

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
Pr
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 mg and 10 mg
donepezil hydrochloride (as donepezil hydrochloride monohydrate)
CHOLINESTERASE INHIBITOR
Manufactured by:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090
India
Imported and Distributed by:
Date of Revision:
DR. REDDY’S LABORATORIES CANADA INC.,
October 31, 2022
Mississauga, ON L4W 4Y1
Canada
Submission
Control Number: 264379
2
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
.......................................................................................................15
DOSAGE AND ADMINISTRATION
....................................................................................17
OVERDOSAGE.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
...............................................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................21
PART II: SCIENTIFIC INFORMATION
...........................................................................22
PHARMACEUTICAL INFORMATION
................................................................................22
CLINICAL
TRIALS..........