Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
IRINOTECAN HYDROCHLORIDE
AURO PHARMA INC
L01CE02
IRINOTECAN
500MG
SOLUTION
IRINOTECAN HYDROCHLORIDE 500MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0132910001; AHFS:
APPROVED
2020-07-07
Page 1 of 58 PRODUCT MONOGRAPH PR IRINOTECAN HYDROCHLORIDE INJECTION (Irinotecan hydrochloride trihydrate) Sterile Solution 20 mg / mL House Standard (40 mg / 2 mL, 100 mg / 5 mL, 300 mg / 15 mL and 500 mg / 25 mL) Antineoplastic Agent AURO PHARMA INC. Date of Preparation: 3700 Steeles Avenue West, Suite # 402 June 30, 2020 Woodbridge, Ontario, L4L 8K8 CANADA Submission Control Number: 216121 Page 2 of 58 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................3 SUMMARY PRODUCT INFORMATION ......................................................................3 INDICATIONS AND CLINICAL USE ............................................................................3 CONTRAINDICATIONS .................................................................................................4 WARNINGS AND PRECAUTIONS ................................................................................4 ADVERSE REACTIONS ................................................................................................ 11 DRUG INTERACTIONS ................................................................................................21 DOSAGE AND ADMINISTRATION ............................................................................25 OVERDOSAGE .............................................................................................................. 30 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 30 STORAGE AND STABILITY ........................................................................................ 33 SPECIAL HANDLING INSTRUCTIONS ..................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 34 PART II: SCIENTIFIC INFORMATION .............................................................................35 PHARMACEUTICAL INFORMATION ........................................................................ 35 CLINICAL TRIAL Baca dokumen lengkapnya