JAMP-DONEPEZIL TABLETS
Страна: Канада
Език: английски
Източник: Health Canada
Данни за продукта
(SPC)
23-03-2015
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Активна съставка:
DONEPEZIL HYDROCHLORIDE
Предлага се от:
JAMP PHARMA CORPORATION
АТС код:
N06DA02
INN (Международно Name):
DONEPEZIL
дозиране:
5MG
Лекарствена форма:
TABLET
Композиция:
DONEPEZIL HYDROCHLORIDE 5MG
Начин на приложение:
ORAL
Броя в опаковка:
28/30/250
Вид предписание :
Prescription
Терапевтична област:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Каталог на резюме:
Active ingredient group (AIG) number: 0131548001; AHFS:
Статус Оторизация:
APPROVED
Дата Оторизация:
2013-12-27
Данни за продукта
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
.........................................................................
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