DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DOXORUBICIN HYDROCHLORIDE

Commercializzato da:

PANDA PHARMACEUTICALS INC.

Codice ATC:

L01DB01

INN (Nome Internazionale):

DOXORUBICIN

Dosaggio:

50MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

DOXORUBICIN HYDROCHLORIDE 50MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2017-08-16

Scheda tecnica

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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
.........................