MIDODRINE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MIDODRINE HYDROCHLORIDE

متاح من:

SANIS HEALTH INC

ATC رمز:

C01CA17

INN (الاسم الدولي):

MIDODRINE

جرعة:

5MG

الشكل الصيدلاني:

TABLET

تركيب:

MIDODRINE HYDROCHLORIDE 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

ملخص المنتج:

Active ingredient group (AIG) number: 0123066002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2022-12-01

خصائص المنتج

Page 1 of 23
PRODUCT MONOGRAPH
Pr
MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS
2.5 MG AND 5 MG
MANUFACTURER’S STANDARD
VASOPRESSOR
Sanis Health Inc.
Date of Preparation:
1 President’s Choice Circle
NOV 30, 2022
Brampton, Ontario
L6Y 5S5
Submission Control No.:
269308
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
......................................................................................................................
18