2/27/2014 9:53:54 AM
KING OF PRUSSIA, Pa., Feb. 27, 2014 /PRNewswire/ -- CSL BiotherapiesInc. announced today it has changed its name to bioCSL Inc., effective February 21, 2014. This change is pursuant to the Australian, New Zealand and German renaming of the company, which occurred one year ago.
In September 2013, bioCSL was the first United States supplier to complete its 2013-14 seasonal influenza vaccine delivery campaign, which consisted of more than 11 million doses of AFLURIA® (Influenza Vaccine) delivered to the United States marketplace.
In addition to the name change for the U.S. entity, the company has initiated pre-ordering of AFLURIA for the 2014-15 season through national distributors and with order requests received via the brand's website, www.afluria.com.
"We are excited about serving the needs of our customers with our new US sales, marketing, and operations team. To date, we have received highly favorable comments from customers and business partners who recognize AFLURIA® as an important influenza vaccine choice due to its reliable and timely delivery performance this year," said Dr. Marie Mazur, President of bioCSL Inc.
AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.
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AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with post-marketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by post-marketing studies. Febrile events were also observed in children 5 to less than 9 years of age. If Guillain-Barre Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. AFLURIA should be given to a pregnant woman only if clearly needed. AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman. Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects. In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, malaise, and fever. In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. The most common systemic adverse reactions observed were headache, malaise, and muscle aches. In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. Vaccination with AFLURIA may not protect all individuals. Before administering AFLURIA, please read the Prescribing Information.
About bioCSL Inc.
bioCSL Inc., located in King of Prussia, Pennsylvania, is the United States headquarters of bioCSL. Parent company, CSL Limited, has manufactured influenza vaccine in its Melbourne, Australia, facility since 1968. CSL Limited has made a $60 million (U.S.D.) investment in plant and equipment to double capacity at its Melbourne facility, making it one of the largest vaccine manufacturing facilities in the world. CSL-branded influenza vaccines are approved in 28 countries. At bioCSL Inc., delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Plasma, and CSL Behring, has more than 11,000 employees globally and operates in 26 countries around the world.
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SOURCE bioCSL Inc.
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