SANDOZ CYCLOSPORINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CYCLOSPORINE

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

L04AD01

DCI (Dénomination commune internationale):

CICLOSPORIN

Dosage:

25MG

forme pharmaceutique:

CAPSULE

Composition:

CYCLOSPORINE 25MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

IMMUNOSUPPRESSIVE AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2005-03-03

Résumé des caractéristiques du produit

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