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.
Kabiven and Perikabiven are now the first and only three-chamber bags in the United States for parenteral nutrition. The bag provides premixed solution that is shelf-stable until activated (by rolling) for patient use.
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.