DOCETAXEL INJECTION SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DOCETAXEL

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

L01CD02

INN (International Name):

DOCETAXEL

Dosering :

80MG

Legemiddelform:

SOLUTION

Sammensetning:

DOCETAXEL 80MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

2.88ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-05-17

Preparatomtale

_ _
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
.............................