CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CYCLOPHOSPHAMIDE

Beszerezhető a:

ACCORD HEALTHCARE INC

ATC-kód:

L01AA01

INN (nemzetközi neve):

CYCLOPHOSPHAMIDE

Adagolás:

1000MG

Gyógyszerészeti forma:

POWDER FOR SOLUTION

Összetétel:

CYCLOPHOSPHAMIDE 1000MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

100

Recept típusa:

Prescription

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2022-09-16

Termékjellemzők

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