Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CLADRIBINE
EMD SERONO, A DIVISION OF EMD INC., CANADA
L04AA40*
CLADRIBINE
10MG
TABLET
CLADRIBINE 10MG
ORAL
1/4/5/6/7/8
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0124270002; AHFS:
APPROVED
2017-11-30
_MAVENCLAD_ _®_ _ (cladribine) Product Monograph _ _Page 1 of 39 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MAVENCLAD® Cladribine 10 mg Tablet, oral Selective Immunosuppressant TREATMENT WITH MAVENCLAD SHOULD BE INITIATED AND SUPERVISED BY NEUROLOGISTS EXPERIENCED IN THE TREATMENT OF PATIENTS WITH MS AND WHO HAVE FULLY FAMILIARIZED THEMSELVES WITH THE EFFICACY AND SAFETY PROFILE OF MAVENCLAD. EMD Serono, a Division of EMD Inc., Canada 2695 North Sheridan Way, Suite 200 Mississauga, Ontario L5K 2N6 www.emdserono.ca EMD Serono is a business of Merck KGaA, Darmstadt, Germany Date of Initial Authorization: November 29, 2017 Date of Revision: October 7, 2021 Submission Control Number: 249245 MAVENCLAD is a trademark of Merck KGaA, Darmstadt, Germany or its affiliates. _MAVENCLAD_ _®_ _ (cladribine) Product Monograph _ _Page 2 of 39 _ RECENT MAJOR LABEL CHANGES 4.1 Dosing Considerations 10/2021 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic 10/2021 7 Warnings and Precautions, Immune, Hypersensitivity 10/2021 2 Contraindications 11/2020 4.1 Dosing Considerations 11/2020 7 Warnings and Precautions, General, Carcinogenesis and Mutagenesis, Sexual Function/Reproduction 11/2020 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics (< 18 years of age).............................................................................. 4 1.2 Geriatrics (> 65 years of age) .............................................................................. Baca dokumen lengkapnya