APO-CYCLOSPORINE ORAL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CYCLOSPORINE

Dostupné s:

APOTEX INC

ATC kód:

L04AD01

INN (Mezinárodní Name):

CICLOSPORIN

Dávkování:

100MG

Léková forma:

SOLUTION

Složení:

CYCLOSPORINE 100MG

Podání:

ORAL

Jednotky v balení:

50ML

Druh předpisu:

Prescription

Terapeutické oblasti:

IMMUNOSUPPRESSIVE AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0115996001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-01-11

Charakteristika produktu

PRODUCT MONOGRAPH
PR
APO-CYCLOSPORINE ORAL SOLUTION
CYCLOSPORINE ORAL SOLUTION USP
100 MG / ML
IMMUNOSUPPRESSANT
APOTEX INC.
150 SIGNET DRIVE
WESTON, ONTARIO
M9L 1T9
DATE OF REVISION:
APRIL 27, 2020
CONTROL NUMBER: 236774
_APO-CYCLOSPORINE Product Monograph _
_ _
_Page 2 of 61 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
.......................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 30
STORAGE AND STABILITY
.................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
35
PHARMACEUTICAL INFORMATION
.................................................................................
35
CLINICAL TRIALS
..............................................................................................................