JAMP MIDODRINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
30-06-2021
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Aktiv ingrediens:
MIDODRINE HYDROCHLORIDE
Tilgjengelig fra:
JAMP PHARMA CORPORATION
ATC-kode:
C01CA17
INN (International Name):
MIDODRINE
Dosering :
5MG
Legemiddelform:
TABLET
Sammensetning:
MIDODRINE HYDROCHLORIDE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
ALPHA-ADRENERGIC AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0123066002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2021-07-08
Preparatomtale
Page 1 of 22
PRODUCT MONOGRAPH
Pr
JAMP MIDODRINE
Midodrine Hydrochloride Tablets USP
2.5 mg and 5 mg of midodrine hydrochloride
Vasopressor
JAMP PHARMA CORPORATION
1310 rue Nobel
Boucherville, Qu
é
bec
J4B 5H3
DATE OF PREPARATION:
June 30, 2021
CONTROL NO.: 235448
Page 2 of 22
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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