Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
VINCRISTINE SULFATE
ACCORD HEALTHCARE INC
L01CA02
VINCRISTINE
1MG
SOLUTION
VINCRISTINE SULFATE 1MG
INTRAVENOUS
2ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107646001; AHFS:
CANCELLED PRE MARKET
2017-08-07
PRODUCT MONOGRAPH PR VINCRISTINE SULFATE INJECTION USP 1 mg/mL Antineoplastic Agent Accord Healthcare Inc. 3100 Steeles Avenue East, Markham, ON, L3R 8T3 Canada Date of Revision: February 4, 2013 CONTROL # 160953 1 PRODUCT MONOGRAPH Pr Vincristine Sulfate Injection USP 1 mg/mL THERAPEUTIC CLASSIFICATION Antineoplastic Agent WARNINGS CAUTION: VINCRISTINE SULFATE INJECTION IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS. BLOOD COUNTS SHOULD BE TAKEN ONCE OR TWICE WEEKLY. DISCONTINUE OR REDUCE THE DOSAGE UPON EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE MARROW. THIS PREPARATION SHOULD BE ADMINISTERED BY INDIVIDUALS EXPERIENCED IN THE ADMINISTRATION OF VINCRISTINE SULFATE INJECTION. IT IS EXTREMELY IMPORTANT THAT THE INTRAVENOUS NEEDLE OR CATHETER BE PROPERLY POSITIONED BEFORE ANY VINCRISTINE IS INJECTED. LEAKAGE INTO SURROUNDING TISSUE DURING INTRAVENOUS ADMINISTRATION OF VINCRISTINE SULFATE INJECTION MAY CAUSE CONSIDERABLE IRRITATION. IF EXTRAVASATION OCCURS, THE INJECTION SHOULD BE DISCONTINUED IMMEDIATELY, AND ANY REMAINING PORTION OF THE DOSE SHOULD THEN BE INTRODUCED INTO ANOTHER VEIN. LOCAL INJECTION OF HYALURONIDASE AND THE APPLICATION OF MODERATE HEAT TO THE AREA OF LEAKAGE HELP DISPERSE THE DRUG AND ARE THOUGHT TO MINIMIZE DISCOMFORT AND THE POSSIBILITY OF CELLULITIS. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. SEE 'WARNINGS" SECTION FOR THE TREATMENT OF PATIENTS GIVEN INTRATHECAL VINCRISTINE SULFATE INJECTION. ACTION AND CLINICAL PHARMACOLOGY The complete mode of action of Vincristine Sulfate Injection is unknown. _In vitro _ investigations have demonstrated that vincristine is a spindle inhibitor. This inhibition has been linked to a reversible binding of the drug to microtubule and spindle proteins in S phase. Vincristine has also been associated with an Interference of RNA synthesis. Whether as a result or independent of these actions, vincristine has been shown to arrest cells in metaphase. Pharmacokinetic studies in patients with ca Baca dokumen lengkapnya