Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication - Seite 2

About Baxter’s Global Clinical Nutrition Business

Baxter’s broad portfolio of clinical nutrition products includes metabolic monitors, automated nutrition compounders and parenteral nutrition solutions. These tools and solutions help enable clinicians to measure accurately, mix with control and nourish effectively. Our innovative and accessible clinical nutrition products and services are used extensively across a wide array of acute and alternate care settings.

About Baxter

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X/Twitter, LinkedIn and Facebook.

Indication

CLINOLIPID injection is indicated in adults and pediatric patients, including term and preterm neonates as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Important Risk Information

• The use of CLINOLIPID injection is contraindicated in patients with the following:

− Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
− Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

• Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation.