Country: Canada
Language: English
Source: Health Canada
CAPECITABINE
TARO PHARMACEUTICALS INC
L01BC06
CAPECITABINE
500MG
TABLET
CAPECITABINE 500MG
ORAL
120
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0134120002; AHFS:
APPROVED
2016-09-09
_Taro-Capecitabine (Capecitabine Tablets) _ _Page 1 of 61_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TARO-CAPECITABINE Capecitabine Tablets Tablets, 150 mg and 500 mg, Oral Taro Standard Antineoplastic Agent Taro Pharmaceuticals Inc. 130 East Drive Brampton, Ontario L6T 1C1 Submission Control Number: 253729 Date of Initial Authorization: September 08, 2016 Date of Revision: January 11, 2022 _Taro-Capecitabine (Capecitabine Tablets) Page 2 of 61_ RECENT MAJOR LABEL CHANGES 3. SERIOUS WARNINGS AND PRECAUTIONS BOX 01/2022 4. DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 01/2022 7. WARNINGS AND PRECAUTIONS 01/2022 7. WARNINGS AND PRECAUTIONS, 7.1 Special Populations 01/2022 TABLE OF CONTENTS SECTIONS AND 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 .................................................................................................................. 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 Recommend Read the complete document