Country: Canada
Language: English
Source: Health Canada
CYCLOSPORINE
SANDOZ CANADA INCORPORATED
L04AD01
CICLOSPORIN
100MG
CAPSULE
CYCLOSPORINE 100MG
ORAL
30
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0115996001; AHFS:
APPROVED
2006-02-17
_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 ................................. Read the complete document