DAUNORUBICIN INJECTABLE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE)

Available from:

GENERIC MEDICAL PARTNERS INC

ATC code:

L01DB02

INN (International Name):

DAUNORUBICIN

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE) 20MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-07-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DAUNORUBICIN INJECTABLE SOLUTION
(DAUNORUBICIN HYDROCHLORIDE)
20 MG/4 ML AND 50 MG/10 ML
SOLUTION FOR INJECTION
ANTIMITOTIC—ANTIBIOTIC
GENERIC MEDICAL PARTNERS INC.
Date of Preparation: July 2, 2020
1500 Don Mills Road, Unit 406
Control #: 230856
Toronto, ON,
Canada M3B 3K4
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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: 563.98 g/mol
The hydrochloride is an orange-red crystalline powder. It is freely
soluble in water and in methanol.
It is slightly soluble in alcohol and chloroform. It is practically
insoluble in acetone.
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 Injectable Solution 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.
CONTRAINDICATIONS
CONTRAINDICATIONS
Daunorubicin Injectable Solution 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
Injectable Solution therapy. If during
Daunorubicin Injectable Solution treatment a patient becomes febrile
(regardless of the neutrophil
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count), treatment with broad spectrum antibiotics should be initiated.
Daunorubicin Injectable Solution induces medullary aplasia and
leukopenia. It is therefore
imperative that patients be