MIDODRINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MIDODRINE HYDROCHLORIDE

Pieejams no:

SANIS HEALTH INC

ATĶ kods:

C01CA17

SNN (starptautisko nepatentēto nosaukumu):

MIDODRINE

Deva:

5MG

Zāļu forma:

TABLET

Kompozīcija:

MIDODRINE HYDROCHLORIDE 5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-12-01

Produkta apraksts

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