DOCETAXEL INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DOCETAXEL

متاح من:

TEVA CANADA LIMITED

ATC رمز:

L01CD02

INN (الاسم الدولي):

DOCETAXEL

جرعة:

80MG

الشكل الصيدلاني:

SOLUTION

تركيب:

DOCETAXEL 80MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

2.88ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2018-05-17

خصائص المنتج

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