DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DOXORUBICIN HYDROCHLORIDE

Disponible depuis:

PANDA PHARMACEUTICALS INC.

Code ATC:

L01DB01

DCI (Dénomination commune internationale):

DOXORUBICIN

Dosage:

50MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

DOXORUBICIN HYDROCHLORIDE 50MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-08-16

Résumé des caractéristiques du produit

_Doxorubicin Hydrochloride for Injection USP _
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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 _
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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
.........................