DOCETAXEL INJECTION SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

DOCETAXEL

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

L01CD02

INN (International namn):

DOCETAXEL

Dos:

80MG

Läkemedelsform:

SOLUTION

Sammansättning:

DOCETAXEL 80MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

2.88ML

Receptbelagda typ:

Prescription

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2018-05-17

Produktens egenskaper

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