Healthcare Industry News: Baxter International
News Release - October 11, 2006
Baxter Announces Launch of BAXJECT(R) II Needle-Less Transfer Device for ADVATE(R)Latest Convenience Feature for ADVATE Now Available in the United States and European Union
DEERFIELD, Ill., Oct. 11 (HSMN NewsFeed) -- Baxter Healthcare Corporation today announced the availability of BAXJECT II, an innovative needle-less transfer device designed to make the reconstitution and mixing of hemophilia factor therapies easier, faster and safer (as compared to the original BAXJECT and needles). BAXJECT II is the newest convenience feature to be added to ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin- Free Method], the only factor VIII therapy free of blood-based additives. Unlike other devices, BAXJECT II is compatible with existing injection ports and butterfly sets.
"With a busy schedule, mixing an infusion is time consuming," says patient, Ellis Sulser. "The BAXJECT II device is an improvement in that it speeds up the process while making it safer by eliminating the need for needles to mix my factor VIII."
BAXJECT II is the latest needle-less transfer device from Baxter that has been totally redesigned with features that patients may find make mixing of hemophilia therapy easier, faster and safer (as compared to the original BAXJECT and needles). With its integrated filter, it allows patients to use the butterfly infusion set of their choice.
The new BAXJECT II design makes mixing easier by avoiding the need for valve turning and air injection while facilitating connection with a straightforward color-coding system. Mixing time is faster -- less than a minute(1) -- thanks to fewer mixing steps; and safety is improved by the inclusion of built-in filters to maintain product purity, as well as a reduced risk of injury because the needle-less design contains no glass parts or syringes.
"The introduction of BAXJECT II is a result of the hemophilia community's recommendation to further improve the ease of infusion," said Ron Lloyd, vice president of global marketing for Baxter's BioScience business. "Earlier this year we introduced smaller ADVATE packaging and also a new 2000 IU (5mL) Ultra-High dosage of ADVATE. BAXJECT II is yet another example of Baxter's ongoing commitment to improve the convenience of treatment for people with hemophilia and their families."
About BAXJECT II Availability
In the United States, BAXJECT II can be used with ADVATE and all other Baxter factor VIII therapies. In addition, U.S. patients and caregivers can learn more about BAXJECT II by visiting http://www.BAXJECT2.com . Demonstration kits can be ordered by calling 1-866-4-BIOSCI.
BAXJECT II was launched in Europe and Australia in June where it was introduced in combination with new patient-friendly ADVATE packaging.
The BAXJECT II device is intended for use with a single vial of FVIII product and is for single use only. Therefore, reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device.
Rx Only. For safe and proper use of the BAXJECT II device, please refer to the Instructions For Use ( http://www.baxject2.com/downloads/instructions.pdf ).
Reference: 1. Data on file. Westlake Village, Calif: Baxter Healthcare Corporation.
About Hemophilia A
People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary to effectively clot blood. Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints. If untreated, patients with severe hemophilia A have a greatly reduced life expectancy.
According to the World Health Organization, more than 400,000 people in the world may have hemophilia, corresponding to a prevalence of 15 to 20 in every 100,000 males born worldwide.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX ). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
ADVATE is currently approved for use in the United States, Australia and 28 countries in the European Union.
ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to properly function. ADVATE is the only recombinant factor VIII therapy processed without blood or blood additives, including human albumin or other plasma protein additives.
ADVATE is also indicated in the perioperative management of patients with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand's disease.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing. The formation of inhibitors has been observed with all factor VIII concentrates, including ADVATE.
Patients and caregivers in the United States can obtain more information on ADVATE, including full Prescribing Information, at http://www.ADVATE.com .
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