Products Affected - Description

• • Trace Elements injection, American Regent, Trace elements-4 pediatric 10 mL vial, 25 count, NDC 00517-9310-25

Reason for the Shortage

• • American Regent has all presentations of Multitrace injection fully available. Trace elements-4 pediatric injection is not available.[1]
  • American Regent is the sole supplier of FDA-approved combined trace elements.
  • In cooperation with FDA, Fresenius Kabi USA was providing Addamel N (adult trace element injection) and Peditrace (pediatric trace element injection) to the US market to help alleviate the shortage. These are no longer being imported but may still be available for a period of time through wholesalers.[2,3]

Available Products

• • Imported Product - Addamel N injection, Fresenius Kabi, Addamel N 10 mL ampule, 20 count, NDC 63323-0143-97
  • Multitrace injection, American Regent, Multitrace-5 Concentrate 1 mL vial, 25 count, NDC 00517-8201-25
  • Multitrace injection, American Regent, Multitrace-4 Concentrate 1 mL vial, 25 count, NDC 00517-7201-25
  • Multitrace injection, American Regent, Multitrace-5 Regular 10 mL vial, 25 count, NDC 00517-8510-25
  • Multitrace injection, American Regent, Multitrace-4 Concentrate 10 mL vial, 25 count, NDC 00517-7210-25
  • Multitrace injection, American Regent, Multitrace-5 Concentrate 10 mL vial, 25 count, NDC 00517-8210-25
  • Multitrace injection, American Regent, Multitrace-4 Regular 10 mL vial, 25 count, NDC 00517-7410-25
  • Imported Product - Peditrace injection, Fresenius Kabi, Peditrace Concentrate 10 mL vial, 10 count, NDC 63323-0147-10
  • Multitrace injection, American Regent, Multitrace-4 Neonatal 2 mL vial, 25 count, NDC 00517-6202-25
  • Multitrace injection, American Regent, Multitrace-4 Pediatric 3 mL vial, 25 count, NDC 00517-9203-25

• • American Regent has trace elements-4 pediatric 10 mL vials on back order and the company cannot estimate a release date. All Multi-Trace presentations are readily available.[1]

• • Trace elements are commonly used in parenteral nutrition solutions to prevent deficiencies.[4]

• • Dosing differs between the imported and FDA approved product. Use caution when switching between products.[2]
  • Bar coding systems should not be used with Addamel N ampules or Peditrace vials as incorrect information may be provided if the item is scanned.[2]
  • Addamel N contains iron and compatibility testing with US products containing intravenous fat emulsion have not been conducted.[2]
  • Report any offers to sell Addamel N or Peditrace by an entity other than Fresenius Kabi to [email protected]. Fresenius Kabi USA will only be releasing product to the following distributors: Amerisource Bergen, McKesson, Cardinal, Morris & Dickson, and HD Smith.

• • Addamel N is supplied in a 10 mL single dose ampule and contains zinc chloride, copper chloride, manganese chloride, chromic chloride, sodium selenite, ferric chloride, sodium molybdate, potassium iodide, and sodium fluoride.[5] Addamel N is preservative-free. Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products and this is available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM355392.pdf.
  • Peditrace is supplied in a 10 mL single dose vial and contains zinc chloride, copper chloride, manganese chloride, sodium selenite, potassium iodide, and sodium fluoride. Peditrace does not contain chromium and is preservative-free.[6] Fresenius Kabi has a Dear Healthcare professional letter that summarizes the key differences between products and this is available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM354265.pdf.
  • Additional information regarding the use of Peditrace in the preterm and term newborn population with regard to iodine and fluoride content is available at: http://fresenius-kabi.us/images/documents/our-products/Peditrace_I_F_Statement_JP_final_2014-04-30_signed.pdf.
  • Product labeling for Addamel N injection is available at: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=af41ecf5-7281-48f2-8951-879f93a39681.
  • Product labeling for Peditrace injection is available at: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd13f750-9d7b-4ac4-8433-1d2c20adb266.
  • The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage online at https://www.nutritioncare.org/Professional_Resources/Drug_Shortages_Update/.[7]
  • Key recommendations include: -Reserve supplies for neonatal or pediatric patients or other vulnerable groups such as patients with short bowel or malabsorption syndromes. -Avoid use of pediatric trace elements for adult patients. -Adult trace element products are not recommended for pediatric patients. -Consider oral or enteral multivitamin or multi-mineral products for supplementation if possible. -Avoid using trace elements additives in IV fluids. -Increase vigilance of signs and symptoms of trace element deficiencies. -Purchase only the supply needed, do not stockpile.
  • American Society for Parenteral and Enteral Nutrition published a position paper regarding parenteral multivitamin and multi-trace element products. This paper provides dosing recommendations and a summary of European trace elements compared to products available in the US.[8]

• 1. American Regent Laboratories (personal communications and website). November 1 and 16, December 4, 2012; January 4 and 21, February 20, March 4, 18, and 20, April 9, May 9 and 28, June 4, July 29, September 5 and 19, October 31, November 26, 2013; January 2, 15, 16, and 27, March 13, May 1, June 16, July 3 and 30, August 12, September 3 and 29, October 23, December 2, 2014; January 14, February 4 and 26, March 4 and 25, April 10, May 1 and 19, June 12, July 28, September 15, October 1, and November 4 and 17, 2015.
  2. Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letter). http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM354265.pdf and http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM355392.pdf. Accessed May 29, 2013.
  3. Fresenius Kabi (personal communications). May 28, June 4, 24, and 27, July 29, September 5 and 19, November 26, 2013; January 1, May 1, June 5, July 1, September 29, October 23, November 26, 2014; January 13, February 4 and 24, March 3 and 23, April 8 and 29, May 13, June 12, July 23, and September 10, 2015.
  4. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.
  5. Fresenius Kabi. Addamel N Concentrate for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
  6. Fresenius Kabi. Peditrace Concentrate for Solution for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
  7. American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte / Mineral Product Shortage Considerations. Available at: https://www.nutritioncare.org/Professional_Resources/PN_Electrolyte_Shortage/. Accessed May 28, 2013.
  8. Vanek VW, Borum P, Buchman A, Fessler TA, et al. A.S.P.E.N. position paper: recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012 Aug;27(4):440-91.