APO-MIDODRINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
16-10-2018
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Werkstoffen:
MIDODRINE HYDROCHLORIDE
Beschikbaar vanaf:
APOTEX INC
ATC-code:
C01CA17
INN (Algemene Internationale Benaming):
MIDODRINE
Dosering:
2.5MG
farmaceutische vorm:
TABLET
Samenstelling:
MIDODRINE HYDROCHLORIDE 2.5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
ALPHA-ADRENERGIC AGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0123066001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2006-03-13
Productkenmerken
Page 1 of 23
PRODUCT MONOGRAPH
Pr
APO-MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS USP
2.5 MG AND 5 MG
VASOPRESSOR
APOTEX INC. DATE OF PREPARATION
150 SIGNET DRIVE OCTOBER 16, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NO. 219481
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 4
SUMMARY PRODUCT INFORMATION
.............................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................
4
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
9
DOSAGE AND ADMINISTRATION
...................................................................................
10
OVERDOSAGE
......................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 11
STORAGE AND STABILITY
...............................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 13
PART II: SCIENTIFIC INFORMATION
.............................................................................
14
PHARMACEUTICAL INFORMATION
...............................................................................
14
CLINICAL TRIALS
...............................................................................................................
16
DETAILED PHARMACOLOGY
...........................................
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