TARO-DOCETAXEL SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DOCETAXEL

Verfügbar ab:

TARO PHARMACEUTICALS INC

ATC-Code:

L01CD02

INN (Internationale Bezeichnung):

DOCETAXEL

Dosierung:

20MG

Darreichungsform:

SOLUTION

Zusammensetzung:

DOCETAXEL 20MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

5ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2022-07-11

Fachinformation

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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
.............................................................