Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
TEMOZOLOMIDE
TARO PHARMACEUTICALS INC
L01AX03
TEMOZOLOMIDE
140MG
CAPSULE
TEMOZOLOMIDE 140MG
ORAL
5/20
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0138781006; AHFS:
APPROVED
2015-07-08
_TARO-TEMOZOLOMIDE (temozolomide) _ _ _ Page 1 of 57 _ _ PRODUCT M O N O GRAP H INCLUDING PATIENT MEDICATION IN FO RMA T I O N TARO-TEMOZOLOMIDE Temozolomide Capsu l es Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg, ora l Taro Standard Antineoplastic Agent Taro Pharmaceuticals Inc. 130 East Drive, Brampton Ontario, Canada L6T 1C1 Date of Initial Author i zat i on: July 08, 2015 Date of Rev i s i on: September 15, 2023 Submission Control Number: 268736 _TARO-TEMOZOLOMIDE (temozolomide) _ _ _ Page 2 of 57 _ _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS: Reproductive Health: Female and Male Potential 09/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................................ 2 SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. ................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................................... 4 1 INDICATIONS .............................................................................................................................. 4 1.1 Pediatrics ............................................................................................................................... 4 1.2 Geriatrics ............................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................................. 5 4.1 Dosing Considerations ....................................................................................... Perskaitykite visą dokumentą