TAXOTERE SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DOCETAXEL

Pieejams no:

SANOFI-AVENTIS CANADA INC

ATĶ kods:

L01CD02

SNN (starptautisko nepatentēto nosaukumu):

DOCETAXEL

Deva:

80MG

Zāļu forma:

SOLUTION

Kompozīcija:

DOCETAXEL 80MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

2ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0127884001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2020-07-31

Produkta apraksts

Page 1 of 63
PRODUCT MONOGRAPH
PR
TAXOTERE
®
(docetaxel for injection)
CONCENTRATED SOLUTION
80 MG/2.0 ML
20 MG/0.5 ML
Manufacturer’s Standard
_ _
ATC CODE: L01C D02
ANTINEOPLASTIC AGENT
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) H7V 0A3
Date of Revision:
June 15, 2020
Submission Control No.: 237181
Page 2 of 63
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................5
ADVERSE REACTIONS
...............................................................................................10
DRUG INTERACTIONS
................................................................................................30
DOSAGE AND ADMINISTRATION
............................................................................31
OVERDOSAGE
..............................................................................................................36
ACTION AND CLINICAL PHARMACOLOGY
..........................................................36
STORAGE AND STABILITY
.......................................................................................37
SPECIAL HANDLING INSTRUCTIONS
.....................................................................38
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................38
PART II: SCIENTIFIC INFORMATION
................................................................................40
PHARMACEUTICAL INFORMATION
.......................................................................40
CLINICAL TRIALS
.....................................................................