PROCYTOX POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-09-2012
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Active ingredient:
CYCLOPHOSPHAMIDE
Available from:
BAXTER CORPORATION
ATC code:
L01AA01
INN (International Name):
CYCLOPHOSPHAMIDE
Dosage:
200MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
CYCLOPHOSPHAMIDE 200MG
Administration route:
INTRAVENOUS
Units in package:
10ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0107630002; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-02-04
Summary of Product characteristics
_ _
_PROCYTOX (Cyclophosphamide) _
_Page 1 of 65_
PRODUCT MONOGRAPH
Pr
PROCYTOX
Cyclophosphamide Tablets USP:
25 mg, 50 mg
Cyclophosphamide for injection:
200 mg, 500 mg, 1000 mg, 2000 mg (powder for injection) per vial
ANTINEOPLASTIC AGENT
Baxter Corporation
Mississauga, Ontario, L5N OC2
Date of Revision:
September 7, 2012
SUBMISSION CONTROL NO: 155509
Baxter and PROCYTOX are trademarks of Baxter International Inc., its
subsidiaries or affiliates.
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_PROCYTOX (Cyclophosphamide) _
_Page 2 of 65_
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
...............................................................................50
P
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