IRINOTECAN HYDROCHLORIDE INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IRINOTECAN HYDROCHLORIDE

Tersedia dari:

EUGIA PHARMA INC.

Kode ATC:

L01CE02

INN (Nama Internasional):

IRINOTECAN

Dosis:

500MG

Bentuk farmasi:

SOLUTION

Komposisi:

IRINOTECAN HYDROCHLORIDE 500MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0132910001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-07-08

Karakteristik produk

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