APP Pharmaceuticals Launches Enhanced Labeling for Heparin Sodium Injection, USP.- New Labeling to Further Assist Clinicians in Averting Medical Errors with "High-Alert" Medication - SCHAUMBURG, Ill. -- APP Pharmaceuticals, Inc. (Nasdaq:APPX APPX Appendix APPX Application eXcellence (4GL software development tool) ) today announced the launch of enhanced labeling for its line of Heparin Sodium heparin sodium Warning - High-alert drug! Calciparine (UK), Canusal (UK), Hepsal (UK), Hepalean (CA), Heparin Leo (CA), Hep-Lock (CA), Hep-Lock U/P, Monoparin (UK), Multiparin (UK) Injection, USP USP - unique sales point . The labels and cap colors for APP's heparin have incorporated clearly differentiating color combinations since the company began marketing the product in 1998. Also, the current product's labels include bar codes at the individual unit-of-use. APP's new labeling represents further enhancements to help differentiate Heparin Sodium from other heparin products, including Heparin Lock heparin lock Intensive care A cylindrical multiport device with a rubberized access port which is incorporated into a venous access catheter and designed to facilitate IV administration of medications. See Access device, Heparin. Cf Saline lock. Flush Solution, USP. As part of the company's long-standing commitment to patient care and in response to concerns regarding a higher risk of medication errors associated with heparin, the new labeling will further help healthcare professionals quickly identify the correct drug and ultimately administer the proper dose. APP is the sole supplier of therapeutic heparin vials to the U.S. market because drug impurities have forced the other U.S. supplier of heparin vials to withdraw its product from the market. APP continues to work closely with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to ensure that an uninterrupted and safe supply of heparin of the highest quality is available for U.S. patients. According to the Institute for Safe Medication Practices (ISMP ISMP Institute for Safe Medication Practices ISMP InstallShield MultiPlatform ISMP International Society of Meeting Planners ISMP ISF (Information Strike Force) Service Management Plan ISMP Integrated Systems Management Processor ), heparin is a high-alert medication. These medications are defined as bearing a heightened risk of causing significant patient harm when used in error. ISMP encourages healthcare professionals to employ extra safeguards to help reduce the risk of errors. "As a manufacturer of heparin, we consider it our responsibility to help ensure the safest possible use of our products," said Tom Silberg, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , APP Pharmaceuticals. "In bringing critical products like heparin to market, we take a holistic approach holistic approach A term used in alternative health for a philosophical approach to health care, in which the entire Pt is evaluated and treated. See Alternative medicine, Holistic medicine. to safety from how we source raw materials to how we package and label the final product." Specifically, APP's newly designed Heparin Sodium Injection, USP, labels feature: * Simplified upright text and increased focus on a horizontal read of information * Bolded and increased font size by approximately 200 percent for each strength * Even more vibrant cap and label colors for each strength * Notations of total unit strength per mL and total volume * Bar codes at the individual unit-of-use The launch of enhanced labeling for heparin is another example of APP's proactive and independent efforts to help reduce medication errors at the patient level: * APP led the pharmaceutical industry in 2001 by being the first manufacturer to apply bar codes at the unit-of-use level to all of its injectable products launched that year -- 2 years before the FDA's mandate requiring manufacturers to do so * APP proactively includes TALL man lettering to the labels of products to help healthcare professionals differentiate medications with look-alike names * APP carefully selects unique cap and label colors for all products, as it does with heparin * Wherever possible, APP's products are made with latex-free vial stoppers and without preservatives Heparin is indicated for anticoagulant therapy anticoagulant therapy Hematology The use of anticoagulants to prevent intravascular clot formation, or dissolve clots that have already formed Indications DVT/thrombophlebitis, CAD, TIA/stroke, dysrhythmia, prosthetic heart valve, cancer Monitoring Serial for patients undergoing surgery, blood transfusions, extracorporeal circulation extracorporeal circulation n. Circulation of the blood outside the body, as through a heart-lung machine or artificial kidney. , dialysis procedures and other settings that require a blood-clotting inhibitor. Product with the new labeling will begin arriving at hospitals and dialysis centers nationwide the week of June 2, 2008. APP supplies Heparin Sodium Injection, USP, in the following strengths: 2,000 USP Units/2 mL (SDV (Switched Digital Video) See switched video. ); 50,000 USP Units/10 mL (MDV MDV mucosal disease virus. ); 1,000 USP Units/1 mL (MDV); 10,000 USP Units/10 mL (MDV); 30,000 USP Units/ 30 mL (MDV); 10,000 USP Units/1 mL (MDV); 50,000 USP Units/5 mL (MDV); 20,000 USP Units/1 mL (MDV); 5,000 USP Units/1 mL (SDV). Healthcare professionals with questions should contact APP Medical Information at 1-800-551-7176 between the hours of 8 a.m. and 5 p.m. (CST CST abbr. 1. Central Standard Time 2. convulsive shock treatment CST Central Standard Time Noun 1. ), or e-mail APPmedicalinfo@APPpharma.com. For Customer Service, please call 1-888-386-1300 between 7:00 a.m. and 6:00 p.m. (CST). In addition, customers will be able to find up-to-date product information on our website: www.APPpharma.com. About APP Pharmaceuticals, Inc. APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit www.APPpharma.com. Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of heparin. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in APP Pharmaceuticals, Inc. Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2007 and other documents it has filed with the Securities and Exchange Commission. The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments. |
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