IRINOTECAN HYDROCHLORIDE INJECTION SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

IRINOTECAN HYDROCHLORIDE

Fáanlegur frá:

AURO PHARMA INC

ATC númer:

L01CE02

INN (Alþjóðlegt nafn):

IRINOTECAN

Skammtar:

100MG

Lyfjaform:

SOLUTION

Samsetning:

IRINOTECAN HYDROCHLORIDE 100MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-07-07

Vara einkenni

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