CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

CYCLOPHOSPHAMIDE

Inapatikana kutoka:

ACCORD HEALTHCARE INC

ATC kanuni:

L01AA01

INN (Jina la Kimataifa):

CYCLOPHOSPHAMIDE

Kipimo:

1000MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

CYCLOPHOSPHAMIDE 1000MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-09-16

Tabia za bidhaa

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