Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)
Clinigen Healthcare Ltd
DEXRAZOXANE HYDROCHLORIDE
DEXRAZOXANE 500 mg
INTRAVENOUS
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
CARDIOXANE- DEXRAZOXANE INJECTION, POWDER, FOR SOLUTION CLINIGEN HEALTHCARE LTD _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- CARDIOXANE 500 MG POWDER FOR SOLUTION FOR INFUSION IMPORTANT DRUG INFORMATION Subject: Temporary Importation of Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride) to address drug shortage issues Dear Healthcare Professional, IMPORTANT RECONSTITUTION NOTE FOR MEDICATION ERROR PREVENTION: PRESCRIBERS AND PHARMACISTS MUST BE ALERT TO THE DIFFERENCES BETWEEN THE FDA-APPROVED DEXRAZOXANE PRODUCTS AND CARDIOXANE’S PRESENTATION AND RECONSTITUTION AND DILUTION INSTRUCTIONS IN ORDER TO PREVENT MEDICATION ERRORS. APPROPRIATE QUALITY ASSURANCE MEASURES SHOULD BE ENACTED TO REDUCE THE RISK OF MEDICATION ERRORS. SEE COMPARISON TABLE BELOW FOR MORE INFORMATION. CARDIOXANE HAS A DIFFERENT VIAL CAPACITY THAN FDA-APPROVED DEXRAZOXANE PRODUCTS, AND, THEREFORE MUST BE RECONSTITUTED WITH A DIFFERENT VOLUME OF WATER FOR INJECTION. CARDIOXANE 500 MG POWDER FOR SOLUTION FOR INFUSION IS PROVIDED IN A VIAL WITH A CAPACITY OF 25 ML. TO RECONSTITUTE, ADD 25 ML WATER FOR INJECTION (USP) TO THE VIAL. THE CONCENTRATION OF THE RESULTING RECONSTITUTION SOLUTION WILL BE 20 MG/ML – THIS SOLUTION SHOULD NOT BE STORED AND MUST BE FURTHER DILUTED BEFORE ADMINISTRATION TO THE PATIENT. FURTHER DILUTE THE RECONSTITUTION SOLUTION WITH LACTATED RINGER'S INJECTION, USP TO A FINAL CONCENTRATION BETWEEN 1.3 AND 3 MG/ML. THE DILUTED INFUSION SOLUTION SHOULD BE USED IMMEDIATELY OR STORED FOR A MAXIMUM OF 4 HOURS UNDER REFRIGERATION. Due to the current critical shortage of Dexrazoxane for Injection, 250 mg/vial and 500 mg/vial in the United States (U.S.) market, Clinigen Healthcare Ltd is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Dexrazoxane for Injection 500 mg/vial. Clinigen Healthcare Ltd has initiated Lees het volledige document