ARSENIC TRIOXIDE SOLUTION FOR INJECTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-11-2019
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ARSENIC TRIOXIDE
Available from:
PHEBRA PTY LTD
ATC code:
L01XX27
INN (International Name):
ARSENIC TRIOXIDE
Dosage:
10MG
Pharmaceutical form:
SOLUTION
Composition:
ARSENIC TRIOXIDE 10MG
Administration route:
INTRAVENOUS
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0108756003; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-04-15
Summary of Product characteristics
_ARSENIC TRIOXIDE SOLUTION FOR INJECTION Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ARSENIC TRIOXIDE SOLUTION FOR INJECTION
(ARSENIC TRIOXIDE)
For Injection
10 mg/10 mL (1 mg/mL) vial
Antineoplastic
Phebra Pty Ltd
19 Orion Road
Lane Cove West
Australia, 2066
Canadian Importer:
ICON Plc
4 Innovation Drive
Dundas, Ontario
L9H 7P3
Date of Revision:
November 7, 2019
Submission Control No: 232909
_ARSENIC TRIOXIDE SOLUTION FOR INJECTION Product Monograph _
_Page 2 of 49 _
TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................3
SUMMARY PRODUCT INFORMATION
............................................................3
INDICATIONS AND CLINICAL USE
..................................................................3
CONTRAINDICATIONS
.......................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................4
ADVERSE REACTIONS
........................................................................................9
DRUG INTERACTIONS
......................................................................................19
DOSAGE AND ADMINISTRATION
..................................................................21
OVERDOSAGE
....................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................24
STORAGE AND STABILITY
..............................................................................27
SPECIAL HANDLING INSTRUCTIONS
...........................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................27
PART II: SCIENTIFIC INFORMATION
....................................................................28
PHARMACEUTICAL INFORMATION
..............................................................28
CLINICAL TRIALS
............................................................................
Read the complete document
