APO-CYCLOSPORINE ORAL SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CYCLOSPORINE

Disponible des:

APOTEX INC

Codi ATC:

L04AD01

Designació comuna internacional (DCI):

CICLOSPORIN

Dosis:

100MG

formulario farmacéutico:

SOLUTION

Composición:

CYCLOSPORINE 100MG

Vía de administración:

ORAL

Unidades en paquete:

50ML

tipo de receta:

Prescription

Área terapéutica:

IMMUNOSUPPRESSIVE AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-01-11

Fitxa tècnica

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
..............................................................................................................