positive aspects [500:3 mg/dL, give the normal dose. Do not mix DaunoXome with other drugs. Preparation Of Solution DaunoXome should be diluted 1:1 with 5% Dextrose Injection (D5W) before administration. Each vial of DaunoXome contains daunorubicin citrate equivalent to 50 mg daunorubicin base, at a concentration of 2 mg/mL. The recommended concentration after dilution is 1 mg daunorubicin/mL of solution. Use aseptic technique. Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in DaunoXome or in the materials recommended for dilution. Withdraw the calculated volume of DaunoXome from the vial into a sterile syringe, and transfer it into a sterile infusion bag containing an equivalent amount of D5W. Administer diluted DaunoXome immediately. If not used immediately, diluted DaunoXome should be refrigerated at 2 8 C (36 46 F) for a maximum of 6 hours. Caution: The only fluid which may be mixed with DaunoXome is D5W; DaunoXome must not be mixed with saline, bacteriostatic agents such as benzyl alcohol, or any other solution. Do not use an in-line filter for the intravenous infusion of DaunoXome. All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DaunoXome is a translucent dispersion of liposomes that scatters light to some degree. Do not use DaunoXome if it appears opaque, or has precipitate or foreign matter present. Procedures for proper handling and disposal of anticancer drugs should be followed. 1 8 How is DaunoXome Supplied DaunoXome is a translucent, red, liposomal dispersion supplied in single use vials, each sealed with a synthetic rubber stopper and aluminum sealing ring with a plastic cap. DaunoXome provides daunorubicin citrate equivalent to 50 mg of daunorubicin base, at a concentration of 2 mg/mL. DaunoXome is supplied under NDC 10885-001-01 for a single unit pack. Storage Store DaunoXome in a refrigerator, 2 8 C (36 46 F). Do not freeze. Protect from light. REFERENCES ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburg, Pa: Oncology Nursing Society; 1999:32 41. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA . 1985;253:1590 1591. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983;1:426 428. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA- A Cancer J for Clin . 1983;33:258 263. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm . 1990;47:1033 1049. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm . 1996;53:1669 1685. Manufactured for Galen US Inc. 25 Fretz Road Souderton PA 18964 For medical information about DaunoXome (daw-nuh-zome), call 1-800-280-5708 DaunoXome is a registered trademark of Galen Limited. Copyright 2011, Galen Limited. All rights reserved. Rev. December 2011 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 10885-001-01 DaunoXome (daunorubicin citrate liposome injection) 50 mg/vial (2 mg/mL) FOR INTRAVENOUS INFUSION ONLY Note: Liposomal Formulation -See Package Insert Prior To Use. Rx only DaunoXome daunorubicin citrate injection, lipid complex Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10885-001 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DAUNORUBICIN CITRATE (DAUNORUBICIN) DAUNORUBICIN 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHOLESTEROL DISTEAROYLPHOSPHATIDYLCHOLINE, DL- SUCROSE GLYCINE CALCIUM CHLORIDE Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:10885-001-01 25 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050704 02/13/2012 Labeler - Galen US Inc (029491194) Establishment Name Address ID/FEI Operations Gilead Sciences Inc 941715849 MANUFACTURE Revised: 05/2012 Galen US Inc Next Interactions Print this page Add to My Med List More about daunorubicin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antibiotics/antineoplastics Consumer resources Daunorubicin Daunorubicin (Conventional) Daunorubicin Intravenous (Advanced Reading) Professional resources Daunorubicin citrate (AHFS Monograph) Daunorubicin hydrochloride (AHFS Monograph) Daunorubicin (FDA) DAUNOrubicin (Conventional) (Wolters Kluwer) Other brands: Cerubidine Related treatment guides Acute Lymphocytic Leukemia Acute Myeloid Leukemia Acute Nonlymphocytic Leukemia] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Antibiotics / antineoplastics Related Drugs antibiotics / antineoplastics Adriamycin , doxorubicin , mitomycin , Doxil , Valstar , epirubicin Acute Nonlymphocytic Leukemia cyclophosphamide , Cytoxan , cytarabine , mitoxantrone , thioguanine , daunorubicin , Novantrone , Cytoxan Lyophilized , More... Acute Myeloid Leukemia vincristine , cytarabine , Mylotarg , Idhifa , daunorubicin , idarubicin , Vyxeos , Rydapt , More... Acute Lymphocytic Leukemia prednisone , methotrexate , Deltasone , cyclophosphamide , Cytoxan , vincristine , Trexall , More... Daunorubicin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! unique
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