OXALIPLATIN INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OXALIPLATIN

Dostupné z:

AURO PHARMA INC

ATC kód:

L01XA03

INN (Medzinárodný Name):

OXALIPLATIN

Dávkovanie:

5MG

Forma lieku:

SOLUTION

Zloženie:

OXALIPLATIN 5MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

100

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0152220003; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-10-21

Súhrn charakteristických

Product Monograph -
Pr
Oxaliplatin Injection
Page 1 of 59
PRODUCT MONOGRAPH
PR
OXALIPLATIN INJECTION
SOLUTION FOR INJECTION
5 MG / ML
(50 MG / 10 ML; 100 MG / 20 ML; 200 MG / 40 ML)
STERILE CONCENTRATE FOR INTRAVENOUS INFUSION MUST BE DILUTED BEFORE ADMINISTRATION
House Standard
ATC code: L01X A03
ANTINEOPLASTIC AGENT
AURO PHARMA INC.
DATE OF PREPARATION:
3700 Steeles Avenue West, Suite # 402
October 18, 2022
Woodbridge, Ontario, L4L 8K8,
Canada.
Submission Control No: 245429
Product Monograph -
Pr
Oxaliplatin Injection
Page 2 of 59
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
3
WARNINGS AND
PRECAUTIONS.....................................................................................
4
ADVERSE REACTIONS
....................................................................................................12
DRUG INTERACTIONS
.....................................................................................................26
DOSAGE AND ADMINISTRATION
..................................................................................27
OVERDOSAGE
..................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
.................................................................32
STORAGE AND STABILITY
.............................................................................................35
SPECIAL HANDLING
INSTRUCTIONS............................................................................35
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................35
PART II: SCIENTIFIC
INFORMATION.........