SANDOZ CYCLOSPORINE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CYCLOSPORINE

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

L04AD01

INN (Διεθνής Όνομα):

CICLOSPORIN

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

CYCLOSPORINE 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

IMMUNOSUPPRESSIVE AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2005-03-03

Αρχείο Π.Χ.Π.

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