DOCETAXEL INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOCETAXEL

Available from:

TEVA CANADA LIMITED

ATC code:

L01CD02

INN (International Name):

DOCETAXEL

Dosage:

80MG

Pharmaceutical form:

SOLUTION

Composition:

DOCETAXEL 80MG

Administration route:

INTRAVENOUS

Units in package:

2.88ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0127884003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-17

Summary of Product characteristics

_ _
PRODUCT MONOGRAPH
PR
DOCETAXEL INJECTION
(docetaxel)
CONCENTRATED SOLUTION 80 MG/2.88 ML
20 MG/0.72 ML
TEVA STANDARD
ANTINEOPLASTIC AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision: September 6, 2017
Submission Control No.: 208587
2
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
.......................................................................................................
28
DOSAGE AND ADMINISTRATION
...................................................................................
29
OVERDOSAGE
.....................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 33
STORAGE AND STABILITY
...............................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
............................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 35
PART II: SCIENTIFIC INFORMATION
...............................................................................
37
PHARMACEUTICAL INFORMATION
...............................................................................
37
CLINICAL TRIALS
.............................