PMS-CYCLOSPORINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-12-2023
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Active ingredient:
CYCLOSPORINE
Available from:
PHARMASCIENCE INC
ATC code:
L04AD01
INN (International Name):
CICLOSPORIN
Dosage:
50MG
Pharmaceutical form:
CAPSULE
Composition:
CYCLOSPORINE 50MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
IMMUNOSUPPRESSIVE AGENTS
Product summary:
Active ingredient group (AIG) number: 0115996003; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-12-05
Summary of Product characteristics
_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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