Država: Kanada
Jezik: angleščina
Source: Health Canada
IRINOTECAN HYDROCHLORIDE
EUGIA PHARMA INC.
L01CE02
IRINOTECAN
40MG
SOLUTION
IRINOTECAN HYDROCHLORIDE 40MG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0132910001; AHFS:
APPROVED
2022-07-08
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 EUGIA PHARMA INC. Date of Preparation: 3700 Steeles Avenue West, Suite # 402 July 6, 2022 Woodbridge, Ontario L4L 8K8 Canada Submission Control Number: 264650 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 TRIALS Preberite celoten dokument