PACLITAXEL FOR INJECTION USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-12-2019
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Active ingredient:
PACLITAXEL
Available from:
STERIMAX INC
ATC code:
L01CD01
INN (International Name):
PACLITAXEL
Dosage:
6MG
Pharmaceutical form:
SOLUTION
Composition:
PACLITAXEL 6MG
Administration route:
INTRAVENOUS
Units in package:
5ML/16.7ML/25ML/50ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0124214001; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-12-03
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PACLITAXEL FOR INJECTION USP
6 mg/mL
Solution for Injection
Sterile
ANTINEOPLASTIC AGENT
SteriMax Inc.
Date of Revision: December 17, 2019
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Control No: 234155
Product Monograph –
Pr
Paclitaxel for Injection USP Page 2 of 49
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
.......................................................................................
8
DRUG INTERACTIONS
......................................................................................
18
DOSAGE AND ADMINISTRATION
....................................................................
20
OVERDOSAGE
..................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 23
STORAGE AND STABILITY
...............................................................................
25
SPECIAL HANDLING INSTRUCTIONS
............................................................. 25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................... 26
PART II: SCIENTIFIC
INFORMATION..........................................................................
27
PHARMACEUTICAL INFORMATION
................................................................. 27
CLINICAL TRIALS
..............................................................................................
28
DETAILED PHARMACOLOGY
...........................................................................
35
TOXICOLOGY
...........
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