MAR-MIDODRINE TABLET
Страна: Канада
Език: английски
Източник: Health Canada
Данни за продукта
(SPC)
16-06-2020
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Активна съставка:
MIDODRINE HYDROCHLORIDE
Предлага се от:
MARCAN PHARMACEUTICALS INC
АТС код:
C01CA17
INN (Международно Name):
MIDODRINE
дозиране:
5MG
Лекарствена форма:
TABLET
Композиция:
MIDODRINE HYDROCHLORIDE 5MG
Начин на приложение:
ORAL
Броя в опаковка:
100
Вид предписание :
Prescription
Терапевтична област:
ALPHA-ADRENERGIC AGONISTS
Каталог на резюме:
Active ingredient group (AIG) number: 0123066002; AHFS:
Статус Оторизация:
APPROVED
Дата Оторизация:
2018-03-19
Данни за продукта
Page 1 of 23
PRODUCT MONOGRAPH
Pr
MAR-MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS
2.5 MG AND 5 MG
MANUFACTURER’S STANDARD
VASOPRESSOR
Marcan Pharmaceuticals Inc.
Date of Preparation:
2 Gurdwara Road, Suite #112,
June 16, 2020
Ottawa, ON, K2E 1A2
Submission Control No:
239625
Page 2 of 23
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
................................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................................
12
OVERDOSAGE
.............................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
14
STORAGE AND STABILITY
......................................................................................................
15
PART II: SCIENTIFIC INFORMATION
........................................................................................
12
PHARMACEUTICAL INFORMATION
......................................................................................
12
CLINICAL TRIALS
...................................................................................................................
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