CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CYCLOPHOSPHAMIDE

Dostopno od:

ACCORD HEALTHCARE INC

Koda artikla:

L01AA01

INN (mednarodno ime):

CYCLOPHOSPHAMIDE

Odmerek:

1000MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

CYCLOPHOSPHAMIDE 1000MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

100

Tip zastaranja:

Prescription

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-09-16

Lastnosti izdelka

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