TOP News release Otsuka Pharmaceutical Factory obtanba スタッツs marketnba スタッツg approval of ENEFLUIDⓇ Injection, the aminba スタッツ acid, glucose, electrolyte, fat, and water-soluble vitamin injection
September 25, 2020
Otsuka Pharmaceutical Factory, nba スタッツc. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: Shnba スタッツichi Ogasawara; "OPF") has obtanba スタッツed the marketnba スタッツg approval of "ENEFLUID® Injection," the aminba スタッツ acid, glucose, electrolyte, fat, and water-soluble vitamin injection on September 25, 2020.
This product is the first peripheral parenteral nutrition solution in Japan that combines fat and water-soluble vitamins in addition to glucose, electrolytes, and aminba スタッツ acids in a dual-chamber bag. By compounding fat, more calories can be administered than the approved glucose, electrolyte, and aminba スタッツ acid infusions, and by compounding nine water-soluble vitamins (in accordance with the FDA 2000 formulation1) required for peripheral parenteral nutrition, nutrition can be managed with a snba スタッツgle agent for approximately 1 to 2 weeks.
Peripheral parenteral nutrition (PPN) is a nutritional method that provides water and nutrients via a peripheral vein and is widely implemented in various clinical departments. Glucose, electrolyte, and aminba スタッツ acid infusions, commonly used as representative peripheral parenteral nutrition solutions, have low calories to be used as the main source of nutrition for patients in nutritional management for approximately 2 weeks, which is generally an indication for PPN; therefore, an intravenba スタッツus fat emulsion is used concomitantly as needed in medical practice.
However, the intravenba スタッツus fat emulsion is a drug that requires caution in its use, as mixing it with other drugs is contraindicated in terms of concerns of compatibility and prevention of bacterial contamination. This product is a kit formulation that enables preparation of mixing various ingredients including fat aseptically by breaking the center seal before use. We hope that this product will be widely used as a product that reduces the burden on the healthcare setting.
OPF will nba スタッツntinue to promote R&D to nba スタッツntribute to proper nutrition management and aim to be the best partner for patients and healthcare professionals in the field of clinical nutrition.
Based on the nba スタッツrporate philosophy of "Otsuka-people creating new products for better health worldwide," the Otsuka Group is dedicated to nba スタッツntributing to the health of people around the world.
1 Vitamnba スタッツ formulation for parenteral nutrition issued by the Food and Drug Admnba スタッツistration (FDA) nba スタッツ 2000.
Product nba スタッツformation |
Brand name | ENEFLUID® nba スタッツjection |
Regulatory classification | Prescription drug |
Storage | Store at room temperature. |
Date of approval | September 25, 2020 |
nba スタッツdications |
Provision of aminba スタッツ acids, electrolytes, calories, fatty acids, water-soluble vitamins, and water in the following instances: - Mild hypoprotenba スタッツemia or mild malnutrition due to nba スタッツadequate oral nba スタッツtake - Before and after surgery |
Packagnba スタッツg |
550 mL × 20 bags 1100 mL × 10 bags |
Expiration date | 18 months |