TARO-DOCETAXEL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOCETAXEL

Available from:

TARO PHARMACEUTICALS INC

ATC code:

L01CD02

INN (International Name):

DOCETAXEL

Dosage:

160MG

Pharmaceutical form:

SOLUTION

Composition:

DOCETAXEL 160MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0127884004; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2022-07-11

Summary of Product characteristics

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_Taro-Docetaxel - Product Monograph _
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_Page 1 of 57 _
PRODUCT MONOGRAPH
PR
TARO-DOCETAXEL
(Docetaxel for Injection)
Single Vial Formulation
CONCENTRATED SOLUTION
20 MG / ML
80 MG / 4 ML
160 MG / 8 ML
USP Standard
FOR INTRAVENOUS INFUSION, MUST BE DILUTED BEFORE USE
ANTINEOPLASTIC AGENT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive, Brampton August 10, 2021
Ontario L6T 1C1
Submission Control No: 253784
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_Taro-Docetaxel - Product Monograph _
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_Page 2 of 57 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
....................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
.............................................................