CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CYCLOPHOSPHAMIDE

Доступно од:

ACCORD HEALTHCARE INC

АТЦ код:

L01AA01

INN (Међународно име):

CYCLOPHOSPHAMIDE

Дозирање:

1000MG

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

CYCLOPHOSPHAMIDE 1000MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

100

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-09-16

Карактеристике производа

_ 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
................