CERUBIDINE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE)

Available from:

SEARCHLIGHT PHARMA INC

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:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2000-10-02

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CERUBIDINE
Daunorubicin Hydrochloride for Injection
Powder for Solution, 20 mg / vial daunorubicin (as daunorubicin
hydrochloride), Intravenous
Manufacturer’s Standard
Antimitotic—Antibiotic
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Date of Preparation:
OCT 13, 2022
Submission Control No.: 267162
Page 2 of 9
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
CERUBIDINE
®
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.
Page 3 of 9
CONTRAINDICATIONS
CERUBIDINE 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.
CERUBIDINE
®
induces medullary aplasia and leukopenia. It is therefore imperative
that patients
be protected against infection during the period of aplasia.
Daunorubici