DAUNORUBICIN HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE)

Available from:

TEVA CANADA LIMITED

ATC code:

L01DB02

INN (International Name):

DAUNORUBICIN

Dosage:

20MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE) 20MG

Administration route:

INTRAVENOUS

Units in package:

4ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0105870001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DAUNORUBICIN HYDROCHLORIDE FOR INJECTION
20 mg daunorubicin per vial
USP
Antimitotic – Antibiotic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
November 19, 2013
Toronto, Ontario
M1B 2K9
Canada
Control No.: 168893
PRODUCT MONOGRAPH
PR
DAUNORUBICIN HYDROCHLORIDE FOR INJECTION
20 mg daunorubicin per vial
USP
THERAPEUTIC CLASSIFICATION
Antimitotic-Antibiotic
DAUNORUBICIN HYDROCHLORIDE FOR INJECTION MUST BE USED BY
QUALIFIED PRACTITIONERS ONLY, OR UNDER THEIR DIRECT
SUPERVISION.
ACTION AND CLINICAL PHARMACOLOGY
DAUNORUBICIN (R.P. 13 057) is an antibiotic produced by Streptomyces
coeruleorubidis. It is the hydrochloride of
4-methoxy-6,9,11-trihydroxy-7,8,9,10-
tetrahydro-(2,3,6-tridesoxy-3-amino-L-lyxo-1-hexopyranosyl)-7-oxy-9-acetyl
5,12-
naphthacenequinone.
Daunorubicin inhibits the synthesis of nucleic acids, both by binding
deoxyribonucleic
acid and by inhibiting the reproduction of deoxyribonucleic acid and
the synthesis of
ribonucleic acid in the cell nucleus. As a result there is an
interruption of cell division.
INDICATIONS AND CLINICAL USE
DAUNORUBICIN is indicated in the initial treatment of myeloblastic and
acute
lymphoblastic leukemias. It can also induce a remission in patients
suffering from
chronic myeloid leukemia, reticulosarcoma, Ewing or Wilms tumors and
lymphosarcoma.
PRECAUTIONS
There is limited but increasing evidence and concern that personnel
involved in
preparation and administration of parenteral antineoplastics may be at
some risk because
of the potential mutagenicity, teratogenicity, and/or carcinogenicity
of these agents,
although the actual risk is unknown. Cautious handling both in
preparation and disposal
of antineoplastic agents is recommended. Precautions that have been
suggested include:
•
Use of a biological containment cabinet during reconstitution and
dilution of
parenteral medications and wearing of disposable surgical gloves and
masks.
•
Use of proper technique to prevent contamination of the medication,
work area,
and operator during tra