PMS-CYCLOSPORINE CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-12-2023
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Aktiva substanser:
CYCLOSPORINE
Tillgänglig från:
PHARMASCIENCE INC
ATC-kod:
L04AD01
INN (International namn):
CICLOSPORIN
Dos:
25MG
Läkemedelsform:
CAPSULE
Sammansättning:
CYCLOSPORINE 25MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
IMMUNOSUPPRESSIVE AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0115996002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2023-12-05
Produktens egenskaper
_pms-CYCLOSPORINE (Cyclosporine capsules) Product Monograph _
_Page 1 of 62_
PRODUCT MONOGRAPH
PR
PMS-CYCLOSPORINE
(cyclosporine capsules)
Soft gelatin capsules, 25 mg, 50 mg and 100 mg
Mfr. Std.
Immunosuppressant
Pharmascience Inc.
Date of Initial Authorization:
6111 Royalmount Ave., suite 100
DEC 05, 2023
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 281010
_pms-CYCLOSPORINE (Cyclosporine capsules) Product Monograph _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
4
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
DRUG INTERACTIONS
...............................................................................................
21
DOSAGE AND ADMINISTRATION
..........................................................................
27
OVERDOSAGE
..............................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 32
STORAGE AND
STABILITY.......................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 36
PART II: SCIENTIFIC INFORMATION
...............................................................................
37
CLINICAL TRIALS
.......................................................................................................
39
DETAILED PHARMACOLOGY
.................................................................................
49
TOXICOLOGY..................................................
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