TEVA-ARSENIC TRIOXIDE FOR INJECTION SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-01-2019
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Active ingredient:
ARSENIC TRIOXIDE
Available from:
TEVA CANADA LIMITED
ATC code:
L01XX27
INN (International Name):
ARSENIC TRIOXIDE
Dosage:
12MG
Pharmaceutical form:
SOLUTION
Composition:
ARSENIC TRIOXIDE 12MG
Administration route:
INTRAVENOUS
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0108756004; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2021-07-29
Summary of Product characteristics
_TEVA-ARSENIC TRIOXIDE FOR INJECTION_
_ _
_Product Monograph_
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
TEVA-ARSENIC TRIOXIDE FOR INJECTION
(ARSENIC TRIOXIDE)
For Injection
10 mg/10 mL (1 mg/mL) ampoule
12 mg/6 mL (2 mg/mL) stoppered vial
Antineoplastic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
January 2, 2019
Toronto, Ontario
M1B 2K9
Submission Control No.: 221154
_TEVA-ARSENIC TRIOXIDE FOR INJECTION_
_ _
_Product Monograph_
_Page 2 of 44_
TABLE OF CONTENTS
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
....................................................................................................
17
DOSAGE AND ADMINISTRATION
................................................................................
19
OVERDOSAGE
..................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 20
STORAGE AND STABILITY
............................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 23
PART II: SCIENTIFIC
INFORMATION...................................................................................
24
PH
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