DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DOXORUBICIN HYDROCHLORIDE

থেকে পাওয়া:

PANDA PHARMACEUTICALS INC.

এটিসি কোড:

L01DB01

INN (International Name):

DOXORUBICIN

ডোজ:

50MG

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SOLUTION

রচনা:

DOXORUBICIN HYDROCHLORIDE 50MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0110825003; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2017-08-16

পণ্য বৈশিষ্ট্য

_Doxorubicin Hydrochloride for Injection USP _
_ _
_ _
_ _
_Page 1_
_ of 43_
_ _
PRODUCT MONOGRAPH
PR DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP 50 MG / VIAL
Sterile Powder for Solution - Intravenous
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
PANDA PHARMACEUTICALS INC.
35 Nixon Road Unit 10
Caledon, ON
L7E 1K1
Control # 195868
Date of Preparation: August 11, 2017
_Doxorubicin Hydrochloride for Injection USP _
_ _
_ _
_ _
_Page 2_
_ of 43_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...............................................................................................
10
DRUG INTERACTIONS
................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
............................................................................................................
16
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 18
PART II: SCIENTIFIC INFORMATION
...........................................................................
18
PHARMACEUTICAL INFORMATION
...........................................................................
18
CLINICAL TRIALS
.........................