MAR-MIDODRINE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MIDODRINE HYDROCHLORIDE

متاح من:

MARCAN PHARMACEUTICALS INC

ATC رمز:

C01CA17

INN (الاسم الدولي):

MIDODRINE

جرعة:

2.5MG

الشكل الصيدلاني:

TABLET

تركيب:

MIDODRINE HYDROCHLORIDE 2.5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ALPHA-ADRENERGIC AGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0123066001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-03-19

خصائص المنتج

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
...................................................................................................................