据8月27日发布的消息，美国FDA已批准费森尤斯卡比Fresenius Kabi公司的Kabiven和Perikabiven，Kabiven和Perikabiven是将脂肪、葡萄糖、氨基酸和电解质贮存在三腔肠外营养袋中的静脉输注液。三腔肠外营养袋可以控制病人所需的营养物质的体积和浓度。
对于不能通过胃肠道充分消化和吸收营养物质的患者，肠外营养药是通过静脉给予机体营养物质，包括蛋白质、碳水化合物、脂肪、电解质、维生素及其他微量元素。
Kabiven最早在1999年获得上市批准，至今已用于治疗900万患者。目前在除美国外的85个以上的国家都有出售。
Fresenius Kabi公司董事长兼首席执行官John Ducker认为：“本公司希望能够有更多的类似Kabiven和Perikabiven的替代产品在美国上市。这对严重缺乏营养产品的美国市场至关重要。”
Fresenius Kabi Receives FDA approval for Kabiven® and Perikabiven®First and only three-chamber bag available in the United States for parenteral nutrition
LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven® and Perikabiven®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States. Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition.
“Fresenius Kabi is a leader in providing innovative parenteral nutrition products for health care providers and their patients around the world”
Kabiven and Perikabiven are intravenously infused solutions of lipids, dextrose, amino acids and electrolytes in three-chamber parenteral nutrition bags that efficiently deliver these nutrients in volumes and concentrations that meet the nutritional needs of most patients.
The unique three-chamber bag simplifies the delivery of parenteral nutrition by providing a premixed solution that is shelf-stable until activated for patient use.
Outside the United States, Kabiven is sold in more than 85 countries and has been used to treat approximately 9 million patients since its initial marketing authorization in 1999.
“Fresenius Kabi is a leader in providing innovative parenteral nutrition products for health care providers and their patients around the world,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are pleased to bring new alternatives like Kabiven and Perikabiven to U.S. patients. This is especially important as many of the macro- and micro-nutrients in Kabiven and Perikabiven have been in short supply in the United States.”
“The clinical nutrition and pharmacy communities are paying increased attention to improving the safety of parenteral nutrition infusion. Premixed parenteral nutrition solutions such as Kabiven and Perikabiven can be an integral part in standardizing this therapy and can help support PN safety,” said Darlene Kelly, M.D., Ph.D., Advisor for Science and Medicine at the Oley Foundation for Home Parenteral and Enteral Nutrition. “Furthermore, for people who require long-term parenteral nutrition at home, Kabiven and Perikabiven are particularly beneficial because they provide needed nutrition, including lipids, and don’t require refrigeration, making travel more convenient.”
Parenteral nutrition is the intravenous administration of nutrition, which includes protein, carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest, or absorb sufficient nutrition via the gastrointestinal tract.
about Kabiven and Perikabiven
Kabiven and Perikabiven three-chamber bags contain amino acids with electrolytes, dextrose and lipids (Intralipid® 20%). The design of the three-chamber bag keeps the macronutrients separate and shelf-stable until the bag is activated and the contents mixed together for patient use. The formula is intended to meet the daily nutritional requirements of broad patient populations.
Kabiven and Perikabiven three chamber bags must be mixed prior to infusion. For admixing instructions see DIRECTIONS FOR ACTIVATING THE BAG in the prescribing information.
INDICATIONS AND LIMITATIONS OF USE
importANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, Vigilance & Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning, for Kabiven and Perikabiven.
about Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.
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