ZLB Behring Announces Packaging Changes to Carimune NF
ZLB Behring LLC, a CSL Limited company, announced that it will be making several enhancements to the packaging of Carimune(R) NF Immune Globulin Intravenous (Human). These changes are part of the company’s ongoing commitment to enhancing patient safety and improving operational efficiency throughout the healthcare system.
The packaging changes, which will become effective in June, will provide an extra level of protection for patients by increasing product information and helping to ensure that the medication is appropriately dispensed and administered. The packaging enhancements include the following:
– A new RSS (Reduced Space Symbology) bar code will be added at the unit-of-use level to all bottles and boxes of Carimune(R) NF. This new bar code will allow for the lot number, expiration date, Global Trade Identification Number (GTIN) and National Drug Code (NDC) to be included on each bottle and box of Carimune(R) NF. The existing EAN-128 bar code will remain, along with the Global Trade Identification Number (GTIN) and NDC.
– Peel-off labels will be printed with lot number and expiration date. The labels can be easily peeled from the bottle and placed on a patient’s chart, eliminating the need to handwrite this information.
– As an extra measure of safety, a tamper-evident seal will be applied to all cartons of Carimune(R) NF to ensure the integrity and purity of the product.
– All bottles and boxes of Carimune(R) NF will be updated with a bold, new graphic, making the packages more distinctive and recognizable.
"These changes will allow for improved quality of information and safety for both patients and clinicians," said Paul Perreault, ZLB Behring Vice President and General Manager, U.S. Commercial Operations. "The RSS bar code and tamper-evident seal provide an extra level of protection for patients and will help ensure that the appropriate medication is dispensed and administered correctly and received by the right patient."
These enhancements will be instituted on all Carimune(R) NF packages on the U.S. market. In addition to improved safety and convenience, these changes should increase the efficiency of procedures in the event of a product recall.
About Carimune(R) NF
Carimune(R) NF is a sterile, highly purified, plasma-derived Intravenous Immunoglobulin (Human) (IVIG) product used for replacement therapy in patients who do not produce adequate levels of antibodies (or immunoglobulin), e.g., those with primary immunodeficiency, or PID. These antibodies are essential in fighting infectious diseases as well as certain non-infectious diseases, such as autoimmune disorders. Carimune(R) NF also is used to treat certain immune-mediated disorders, such as acute and chronic immune thrombocytopenic purpura (ITP). Carimune(R) NF is the first IGIV in the United States to employ nanofiltration – a passive technology that filters out pathogens above a certain size.
Immune Globulin Intravenous (Human) (IVIG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Please the see full prescribing information for Carimune(R) NF with boxed warning on Acute Renal Failure at www.zlbbehring.com.
About ZLB Behring
ZLB Behring LLC is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company’s broad portfolio of life-saving therapeutics are used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders and inherited emphysema; the prevention of hemolytic diseases for the newborn; cardiac surgery patients; and shock and burn victims. Additionally, ZLB Behring operates one of the world’s largest, fully-owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information about the company, please visit www.zlbbehring.com.