SANDOZ CYCLOSPORINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CYCLOSPORINE

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

L04AD01

INN (Nama Internasional):

CICLOSPORIN

Dosis:

25MG

Bentuk farmasi:

CAPSULE

Komposisi:

CYCLOSPORINE 25MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

IMMUNOSUPPRESSIVE AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2005-03-03

Karakteristik produk

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