CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

CYCLOPHOSPHAMIDE

থেকে পাওয়া:

ACCORD HEALTHCARE INC

এটিসি কোড:

L01AA01

INN (আন্তর্জাতিক নাম):

CYCLOPHOSPHAMIDE

ডোজ:

1000MG

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SOLUTION

রচনা:

CYCLOPHOSPHAMIDE 1000MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2022-09-16

পণ্য বৈশিষ্ট্য

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