JAMP MIDODRINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
30-06-2021
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Aktívna zložka:
MIDODRINE HYDROCHLORIDE
Dostupné z:
JAMP PHARMA CORPORATION
ATC kód:
C01CA17
INN (Medzinárodný Name):
MIDODRINE
Dávkovanie:
5MG
Forma lieku:
TABLET
Zloženie:
MIDODRINE HYDROCHLORIDE 5MG
Spôsob podávania:
ORAL
Počet v balení:
15G/50G
Typ predpisu:
Prescription
Terapeutické oblasti:
ALPHA-ADRENERGIC AGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0123066002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2021-07-08
Súhrn charakteristických
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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