SANDOZ CYCLOSPORINE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CYCLOSPORINE

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

L04AD01

INN (nume internaţional):

CICLOSPORIN

Dozare:

25MG

Forma farmaceutică:

CAPSULE

Compoziție:

CYCLOSPORINE 25MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

IMMUNOSUPPRESSIVE AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2005-03-03

Caracteristicilor produsului

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