DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DOXORUBICIN HYDROCHLORIDE

Disponibil de la:

PANDA PHARMACEUTICALS INC.

Codul ATC:

L01DB01

INN (nume internaţional):

DOXORUBICIN

Dozare:

50MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

DOXORUBICIN HYDROCHLORIDE 50MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-08-16

Caracteristicilor produsului

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