DOCETAXEL INJECTION SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
13-09-2017
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DOCETAXEL
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
L01CD02
INN (Alþjóðlegt nafn):
DOCETAXEL
Skammtar:
80MG
Lyfjaform:
SOLUTION
Samsetning:
DOCETAXEL 80MG
Stjórnsýsluleið:
INTRAVENOUS
Einingar í pakka:
2.88ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0127884003; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-05-17
Vara einkenni
_ _
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
.............................
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