Maa: Kanada
Kieli: englanti
Lähde: Health Canada
DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE)
HIKMA CANADA LIMITED
L01DB02
DAUNORUBICIN
20MG
SOLUTION
DAUNORUBICIN (DAUNORUBICIN HYDROCHLORIDE) 20MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0105870004; AHFS:
APPROVED
2023-06-30
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 Page 2 of 9 Confidential 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. Page 3 of 9 Confidential 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 Lue koko asiakirja