CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CYCLOPHOSPHAMIDE

Dostupné z:

ACCORD HEALTHCARE INC

ATC kód:

L01AA01

INN (Medzinárodný Name):

CYCLOPHOSPHAMIDE

Dávkovanie:

1000MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

CYCLOPHOSPHAMIDE 1000MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

100

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0107630007; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-09-16

Súhrn charakteristických

_ Cyclophosphamide for Injection (Cyclophosphamide)_
_Page 1 of 63_
PRODUCT MONOGRAPH
PR
CYCLOPHOSPHAMIDE FOR INJECTION
USP
500 mg, 1000 mg and 2000 mg per vial
Lyophilized Powder for Injection
ANTINEOPLASTIC AGENT
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC H9H 5B9,
Canada
Date of Initial Approval:
September 14, 2022
Submission Control No: 249010
_ Cyclophosphamide for Injection (Cyclophosphamide)_
_Page 2 of 63_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
..................................................................................................
13
DRUG INTERACTIONS
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
26
OVERDOSAGE
................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 44
STORAGE AND STABILITY
..........................................................................................
46
SPECIAL HANDLING INSTRUCTIONS
........................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 48
PART II: SCIENTIFIC INFORMATION
...............................................................................
49
PHARMACEUTICAL INFORMATION
................