The US Food and Drug Administration has granted approval for Fresenius Kabi’s Kabiven and Perikabiven parenteral nutrition (PN) products in a three-chamber bag.
Fresenius Kabi noted that the three-chamber bag is the only container of its kind available in the US.
Kabiven and Perikabiven three-chamber bags include amino acids with electrolytes, dextrose and lipids (Intralipid 20%).
The PN products are intravenously infused solutions of lipids, dextrose, amino acids and electrolytes, developed to meet the needs of patients.
The three-chamber bag design keeps the macronutrients separate and shelf-stable until the bag is activated and the contents mixed together for patient use.
The bags will efficiently provide these nutrients in volumes and concentrations as per the needs of patients.
Oley Foundation for Home Parenteral and Enteral Nutrition Science and Medicine advisor Darlene Kelly said: "The clinical nutrition and pharmacy communities are paying increased attention to improving the safety of parenteral nutrition infusion.
Fresenius Kabi USA president and CEO John Ducker said: "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."
PN products are administered intravenously to provide protein, carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest, or absorb sufficient nutrition through the gastrointestinal tract.
In 1999, Kabiven received its initial marketing authorization and since then it has been sold in more than 85 countries and also used to treat approximately nine million patients outside the US.
Image: Kabiven and Perikabiven are the first three-chamber bags in the US for parenteral nutrition. Photo: courtesy of Business Wire.