TARO-FAMPRIDINE TABLET (EXTENDED-RELEASE)
Страна: Канада
Език: английски
Източник: Health Canada
Данни за продукта
(SPC)
05-11-2018
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Активна съставка:
FAMPRIDINE
Предлага се от:
TARO PHARMACEUTICALS INC
АТС код:
N07XX07
INN (Международно Name):
FAMPRIDINE
дозиране:
10MG
Лекарствена форма:
TABLET (EXTENDED-RELEASE)
Композиция:
FAMPRIDINE 10MG
Начин на приложение:
ORAL
Броя в опаковка:
(2X14)/(4X14)/28/56
Вид предписание :
Prescription
Терапевтична област:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Каталог на резюме:
Active ingredient group (AIG) number: 0153090001; AHFS:
Статус Оторизация:
APPROVED
Дата Оторизация:
2020-05-15
Данни за продукта
_Page 1 of 31_
PRODUCT MONOGRAPH
Pr
Taro-Fampridine
Fampridine Sustained Release Tablet
10 mg
Potassium Channel Blocker
Taro Pharmaceuticals Inc.
Date of Preparation: November 05, 2018
130 East Drive, Brampton
Ontario L6T 1C1
Submission Control No: 212539
_Page 2 of 31_
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................................................................................................................9
DRUG INTERACTIONS
..............................................................................................................14
DOSAGE AND ADMINISTRATION
..........................................................................................15
OVERDOSAGE
............................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
........................................................................17
STORAGE AND STABILITY
......................................................................................................19
SPECIAL HANDLING INSTRUCTIONS
...................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................19
PART II: SCIENTIFIC INFORMATION
....................................................................................20
PHARMACEUTICAL
INFORMATION....................................................
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