JAMP EPLERENONE TABLET
Država: Kanada
Jezik: engleski
Izvor: Health Canada
Svojstava lijeka
(SPC)
22-11-2023
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Pošalji zahtjev.
Pošalji zahtjev.
Aktivni sastojci:
EPLERENONE
Dostupno od:
JAMP PHARMA CORPORATION
ATC koda:
C03DA04
INN (International ime):
EPLERENONE
Doziranje:
25MG
Farmaceutski oblik:
TABLET
Sastav:
EPLERENONE 25MG
Administracija rute:
ORAL
Jedinice u paketu:
100
Tip recepta:
Prescription
Proizvod sažetak:
Active ingredient group (AIG) number: 0152537001; AHFS:
Status autorizacije:
APPROVED
Datum autorizacije:
2023-11-30
Svojstava lijeka
PRODUCT MONOGRAPH
PR
JAMP EPLERENONE
Eplerenone Tablets, House Standard
25 mg and 50 mg
ALDOSTERONE ANTAGONIST
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Preparation:
November 22, 2023
Submission Control No.: 272992
JAMP Eplerenone (Eplerenone Tablets) Page 2 of 49
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
.......................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................... 19
OVERDOSAGE
......................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.................................................. 22
STORAGE AND STABILITY
...............................................................................
24
SPECIAL HANDLING INSTRUCTIONS
............................................................. 24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 24
PART II: SCIENTIFIC INFORMATION
.....................................................................
25
PHARMACEUTICAL INFORMATION
............................................................... 25
CLINICAL TRIALS
...............................................................................................
27
DETAILED PHARMACOLOGY
..........................................................................
37
TOXICOLOGY
........
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