国: カナダ
言語: 英語
ソース: Health Canada
ETOPOSIDE
FRESENIUS KABI CANADA LTD
L01CB01
ETOPOSIDE
20MG
LIQUID
ETOPOSIDE 20MG
INTRAVENOUS
250ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0114567002; AHFS:
APPROVED
2006-10-04
PRODUCT MONOGRAPH PR ETOPOSIDE INJECTION (Etoposide) 20 mg/mL USP Antineoplastic agent FRESENIUS KABI CANADA LTD. Date of Revision: 165 Galaxy Blvd, Suite 100 May 10, 2017 Toronto, ON M9W 0C8 Submission Control No.: 196647 _Etoposide Injection-Product Monograph _ _ _ _Page 2 of 26 _ PRODUCT MONOGRAPH PR ETOPOSIDE INJECTION 20 mg/mL USP THERAPEUTIC CLASSIFICATION Antineoplastic agent CAUTION: ETOPOSIDE 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. ETOPOSIDE INJECTION CONTAINS BENZYL ALCOHOL. BENZYL ALCOHOL HAS BEEN ASSOCIATED WITH AN INCREASED INCIDENCE OF NEUROLOGICAL AND OTHER COMPLICATIONS IN NEWBORN INFANTS WHICH ARE SOMETIMES FATAL. ACTION 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 Injection-Product Monograph _ _ _ _Page 3 of 26 _ 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 完全なドキュメントを読む