DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DOXORUBICIN HYDROCHLORIDE

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

L01DB01

INN (nume internaţional):

DOXORUBICIN

Dozare:

2MG

Forma farmaceutică:

SOLUTION

Compoziție:

DOXORUBICIN HYDROCHLORIDE 2MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5/25/100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0110825002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2021-04-21

Caracteristicilor produsului

_ _
_Doxorubicin Hydrochloride Injection _
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
DOXORUBICIN HYDROCHLORIDE INJECTION
doxorubicin hydrochloride
2 mg/mL
10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) Vials
Manufacturer’s Standard
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision: June 26, 2019
Submission Control No: 228706
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_Doxorubicin Hydrochloride Injection _
_Page 2 of 46_
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
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................