PMS-CYCLOSPORINE CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CYCLOSPORINE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

L04AD01

INN (mednarodno ime):

CICLOSPORIN

Odmerek:

25MG

Farmacevtska oblika:

CAPSULE

Sestava:

CYCLOSPORINE 25MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

IMMUNOSUPPRESSIVE AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0115996002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-12-05

Lastnosti izdelka

_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..................................................