{"description":["DESCRIPTION Dexrazoxane for injection is a sterile, pyrogen-free lyophilizate intended for intravenous administration. It is a cardioprotective agent for use in conjunction with doxorubicin. Dexrazoxane for injection is available in 250 mg and 500 mg single use only vials. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with the 25 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP diluent provided, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 3.5 to 5.5. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with the 50 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP diluent provided, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 3.5 to 5.5."],"effective_time":"20110926","id":"a6aa11a1-3634-4552-93af-459cd374bcd1","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Dexrazoxane for Injection-250 mg vial label Dexrazoxane for Injection-500 mg vial label Sodium Lactate Injection, USP-25 mLVial Label Sodium Lactate Injection, USP -50 mLVial Label Label 1 Label 2 label 3 label 4"],"set_id":"780d222e-3aa9-46d7-8e32-77d3cc4e9fe2","spl_product_data_elements":["DEXRAZOXANE Dexrazoxane Dexrazoxane Dexrazoxane Dexrazoxane Dexrazoxane Hydrochloric Acid Sodium Lactate Sodium Lactate Sodium Lactate Hydrochloric Acid Sodium Hydroxide Dexrazoxane Dexrazoxane Dexrazoxane Dexrazoxane Dexrazoxane Dexrazoxane Hydrochloric acid Sodium Lactate Sodium Lactate Sodium Lactate Sodium Hydroxide Hydrochloric Acid"],"version":"3"}