País: Canadà
Idioma: anglès
Font: Health Canada
ETOPOSIDE
TEVA CANADA LIMITED
L01CB01
ETOPOSIDE
20MG
LIQUID
ETOPOSIDE 20MG
INTRAVENOUS
5/10/20/25/50ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0114567002; AHFS:
APPROVED
2014-04-03
PRODUCT MONOGRAPH PR ETOPOSIDE INJECTION (etoposide injection, Teva standard) 20 mg/mL ANTINEOPLASTIC AGENT Teva Canada Limited Date of Revision: 30 Novopharm Court April 22, 2016 Toronto, Ontario Canada, M1B 2K9 Control Number: 188887 2 PRODUCT MONOGRAPH PR ETOPOSIDE INJECTION 20 mg/mL THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION: ETOPOSIDE INJECTION IS A POTENT DRUG AND SHOULD BE USED ONLY BY QUALIFIED PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). SEVERE MYELOSUPPRESSION WITH RESULTING INFECTION OR BLEEDING MAY OCCUR. BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. ETOPOSIDE INJECTION CONTAINS POLYSORBATE 80. IN PREMATURE INFANTS A LIFE THREATENING SYNDROME OF LIVER AND RENAL FAILURE, PULMONARY DETERIORATION, THROMBOCYTOPENIA AND ASCITES HAS BEEN ASSOCIATED WITH INJECTABLE VITAMIN E PRODUCT CONTAINING POLYSORBATE 80. ACTIONS AND CLINICAL PHARMACOLOGY Etoposide is a semi-synthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. _In vitro_, etoposide has cytostatic action, which prevents the cells from entering mitosis or destroys them in the premitotic phase. Etoposide interferes with the synthesis of DNA and has a secondary effect on arresting cells in resting (G 2 ) phase in experiments with human lymphoblastic cell lines. Etoposide has a marked action on human hemopoietic cells causing leukopenia and thrombocytopenia. Animal experiments have shown evidence of teratogenicity. An intravenous dose (259 mg/m 2 ) of tritium-labelled etoposide given over one hour in man, showed the mean volume of distribution to be 32% of body weight. The plasma decay was biphasic with a beta half-life of 11.5 hours. Urinary recovery was 44% of which 67% was unchanged drug. Recovery in feces was variable (1.5 - 16%) over a three-day period. In a limited number of children, etoposide administered in a do Llegiu el document complet