TARO-DOCETAXEL SOLUTION

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DOCETAXEL

থেকে পাওয়া:

TARO PHARMACEUTICALS INC

এটিসি কোড:

L01CD02

INN (International Name):

DOCETAXEL

ডোজ:

20MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

DOCETAXEL 20MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

5ML

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0127884004; AHFS:

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2022-07-11

পণ্য বৈশিষ্ট্য

_ _
_Pr_
_Taro-Docetaxel - Product Monograph _
_ _
_Page 1 of 57 _
PRODUCT MONOGRAPH
PR
TARO-DOCETAXEL
(Docetaxel for Injection)
Single Vial Formulation
CONCENTRATED SOLUTION
20 MG / ML
80 MG / 4 ML
160 MG / 8 ML
USP Standard
FOR INTRAVENOUS INFUSION, MUST BE DILUTED BEFORE USE
ANTINEOPLASTIC AGENT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive, Brampton August 10, 2021
Ontario L6T 1C1
Submission Control No: 253784
_ _
_Pr_
_Taro-Docetaxel - Product Monograph _
_ _
_Page 2 of 57 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
....................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
.............................................................