DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DOXORUBICIN HYDROCHLORIDE

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

L01DB01

DCI (Dénomination commune internationale):

DOXORUBICIN

Dosage:

2MG

forme pharmaceutique:

SOLUTION

Composition:

DOXORUBICIN HYDROCHLORIDE 2MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

5/25/100ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-04-21

Résumé des caractéristiques du produit

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