DAUNORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE)

Available from:

HIKMA CANADA LIMITED

ATC code:

L01DB02

INN (International Name):

DAUNORUBICIN

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE) 20MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0105870004; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-06-30

Summary of Product characteristics

Confidential
PRODUCT MONOGRAPH
PR
DAUNORUBICIN HYDROCHLORIDE INJECTION
20 MG / 4 ML
(5 MG / ML) DAUNORUBICIN BASE (AS DAUNORUBICIN HYDROCHLORIDE)
SOLUTION FOR INJECTION
INTRAVENOUS INFUSION ONLY
ANTIMITOTIC—ANTIBIOTIC
Hikma Canada Limited
Date of Revision:
5995 Avebury Road,
June 28, 2023
Suite 804, Mississauga,
Ontario L5R 3P9
Submission Control # 259012
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PHYSICAL AND CHEMICAL DESCRIPTION
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. Its
structural formula is as
follows:
Molecular weight: 564
The hydrochloride is an orange-red microcrystalline powder. It is
soluble in water, methanol
and aqueous alcohol solutions. It is practically insoluble in
chloroform, ether and benzene.
PROPERTIES
Daunorubicin inhibits the synthesis of nucleic acids, both by binding
desoxyribonucleic acid
and by inhibiting the reproduction of desoxyribonucleic acid and the
synthesis of ribonucleic
acid in the cell nucleus. As a result there is an interruption of cell
division.
INDICATIONS
Daunorubicin Hydrochloride Injection 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.
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CONTRAINDICATIONS
Daunorubicin Hydrochloride Injection must not be administered to
patients who exhibit
myocardial lesions or to those above 75 years of age (See WARNINGS and
PRECAUTIONS).
WARNINGS & PRECAUTIONS
Infections should be treated before the start of daunorubicin therapy.
If during daunorubicin
treatment a patient becomes febrile (regardless of the neutrophil
count), treatment with broad
spectrum antibiotics should be initiated.
Daunorubicin Hydrochloride Injection induces medullary aplasia and
leukopenia. It is therefore
im