MAR-MIDODRINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

MIDODRINE HYDROCHLORIDE

Mevcut itibaren:

MARCAN PHARMACEUTICALS INC

ATC kodu:

C01CA17

INN (International Adı):

MIDODRINE

Doz:

5MG

Farmasötik formu:

TABLET

Kompozisyon:

MIDODRINE HYDROCHLORIDE 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ALPHA-ADRENERGIC AGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-03-19

Ürün özellikleri

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