SANDOZ CYCLOSPORINE CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CYCLOSPORINE

Disponível em:

SANDOZ CANADA INCORPORATED

Código ATC:

L04AD01

DCI (Denominação Comum Internacional):

CICLOSPORIN

Dosagem:

100MG

Forma farmacêutica:

CAPSULE

Composição:

CYCLOSPORINE 100MG

Via de administração:

ORAL

Unidades em pacote:

30

Tipo de prescrição:

Prescription

Área terapêutica:

IMMUNOSUPPRESSIVE AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2006-02-17

Características técnicas

_Page 1 of 74 _
_Sandoz Cyclosporine (cyclosporine capsules) _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ CYCLOSPORINE
Cyclosporine Capsules
Soft gelatin capsules, 25 mg, 50 mg and 100 mg, Oral
USP
Immunosuppressant
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1E6
Date of Initial Authorization:
March 3, 2005
Date of Revision:
September 18, 2023
Submission Control Number: 274109
_Page 2 of 74 _
_Sandoz Cyclosporine (cyclosporine capsules) _
RECENT MAJOR LABELS CHANGES
7 WARNINGS AND PRECAUTIONS, Driving and Operating
Machinery
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Population,
7.1.1 Pregnant Women and 7.1.2 Breast-Feeding
09/2023
TABLE OF CONTENT
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABELS CHANGES
..........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.................................