NOW APPROVED! Clinimix [amino acid in dextrose] and Clinimix E [amino acid with electrolytes in dextrose with calcium] Injections with HIGHER PROTEIN*
Clinimix and Clinimix E Injections are the first and only premix products formulated with up to 80 grams of amino acids per liter help meet nutritional goals for your patients.1,2
*Protein is provided as amino acids.Learn More
Baxter and COSMED Announce U.S. FDA 510(k) Clearance of
Q-NRG+ Indirect Calorimetry Device
Q-NRG+, a metabolic monitoring device utilizing Indirect Calorimetry (IC), is now available. IC is considered the "gold standard"5 to accurately measure a patient’s calorie needs, or Resting Energy Expenditure (REE). These readings can help inform prescription and administration of nutrition therapy, which may include Parenteral Nutrition (PN).
Rx Only: For safe and proper use of this device, please refer to User's Manual.
Now Available! Clinolipid 20% Lipid Injectable Emulsion, USP for Nutritional Care
Clinolipid 20% is a unique formulation that enables physicians to minimize the use of soybean oil in their PN, while providing olive oil that is rich in Omega-9 fatty acids.3 Clinolipid Injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
● Clinolipid Injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid Injection provides sufficient amounts of essential fatty acids in this population.
● The omega-3: omega-6 fatty acid ratio in Clinolipid Injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.Learn More
A Patient’s Nutritional Needs Are Complex
In the same way nutrients are an essential part of a patient’s total parenteral nutrition therapy, a pharmacy’s parenteral nutrition portfolio isn’t complete without a variety of nutrients to address adult and pediatric needs. Our comprehensive selection supports your pharmacy’s efficiency and safety goals.
We also offer a variety of education programs and tools for clinicians, hospital partners and compounding pharmacies to help improve care and continue your nutrition education.
Multivitamins for Infusion
We offer low aluminum, preservative-free multivitamins for infusion in adult and pediatric presentations and formulations.
Amino Acids in Dextrose
Protein plays an important role in a patient’s nutrition regimen. We offer Clinimix and Clinimix E (amino acids in dextrose) Injections—now with higher protein—as a source of calories and protein in a variety of formulations and sizes to support specific patient needs. Please read the accompanying full Indication(s) and Important Risk Information and the Package Insert for full Prescribing Information for Clinimix and Clinimix E.
IV Lipid Emulsion
Recognizing the importance of lipids as part of a patient’s total parenteral nutrition therapy, we offer IV lipid emulsions in a variety of concentrations and volumes to meet various needs, including Intralipid (IV Fat Emulsion) in 20% and 30% concentrations. Please read the full Indication(s) and Important Risk Information, including the Boxed Warning for Death in Preterm Infants, and the Package Insert for full Prescribing Information for Intralipid 20% and Intralipid 30%, and for Clinolipid (Lipid Injectable Emulsion), our proprietary 80% olive oil, for Intravenous Use, 20% soybean oil emulsion,3,4 please read the full Indication(s) and Important Risk Information, including the Boxed Warning for Death in Preterm Infants, and the Package Insert for full Prescribing Information.
Compounding Personalized Parenteral Nutrition Solutions With ExactaMix
Explore Baxter's Programs
Baxter’s commitment to advancing clinical nutrition extends beyond offering innovative products. Baxter also provides programs and tools to clinicians, hospital partners and compounding pharmacies that help improve care and pharmacy efficiency.
Portfolio of Offerings
Amino Acid Injections
Clinimix (amino acids in dextrose) Injections
Clinolipid 20% Lipid Injectable Emulsion, USP
Please click here for Full Prescribing information.
Q-NRG+ Metabolic Monitor
Infuvite— Multivitamins for Infusion
Indications and Important Risk Information for Clinolipid
Clinolipid (Lipid Injectable Emulsion) for Intravenous Use 20% Indication
Clinolipid injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
Clinolipid injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid injection provides sufficient amounts of essential fatty acids in this population.
The omega-3: omega-6 fatty acid ratio in Clinolipid injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
Important Risk Information
● Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
● Autopsy findings included intravascular fat accumulation in the lungs.
● Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increase free fatty acid plasma levels following lipid emulsion infusion.
The use of Clinolipid injection is contraindicated in patients with the following:
- Known hypersensitivity to egg or soybean proteins, the lipid emulsion and/or excipients.
- Severe hyperlipidemia or severe disorders of lipid metabolism
Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.
- When admixing Clinolipid, protect the admixed parenteral nutrition solution from light.
Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.
Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.
Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.
Content of vitamin K may counteract anticoagulant activity.
Clinolipid injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.
Reduce dose of Clinolipid injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL.
The most common (5%) adverse drug reactions reported during Clinolipid injection clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
Click here for prescribing information.
Indications and Important Risk Information for Clinimix
CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E (amino acids with electrolytes in dextrose with calcium) Injections are indicated as a source of calories and protein (and electrolytes for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E may be used to treat negative nitrogen balance in patients.
Important Risk Information
- CLINIMIX and CLINIMIX E Injections are contraindicated in patients with known hypersensitivity to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications; and in patients with pulmonary edema or acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated in neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
- Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. Excess addition of calcium and phopshate increases the risk of the formation of calcium phosphate precipitates. The solution should be inspected for precipitates before admixing, after admixing, and again before administration. Protect the activated parenteral nutrition solution from light. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
- Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.
- Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop.
- Monitor for signs and symptoms of early infections.
- Refeeding severely undernourished patients may result in refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely undernourished patients and slowly increase nutrient intakes.
- CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused through a central catheter.
- CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum which may reach toxic levels with prolonged administration in patients with renal impairment. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
- Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. If CLINIMIX and CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.
- Use CLINIMIX and CLINIMIX E with caution in patients with cardiac insufficiency or renal impairment due to increased risk of electrolyte and fluid volume imbalance.
- Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have been corrected.
- Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma.
INTRALIPID 20% (a 20% Intravenous Fat Emulsion) and INTRALIPID 20% and 30% Pharmacy Bulk Packages (a 20% and 30% Intravenous Fat Emulsion)
INTRALIPID 20% (A 20% Intravenous Fat Emulsion) is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).
INTRALIPID 20% Pharmacy Bulk Package (A 20% Intravenous Fat Emulsion) and INTRALIPID 30% Pharmacy Bulk Package (A 30% Intravenous Fat Emulsion) are indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrient admixtures to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).
INTRALIPID 20% AND 30% PHARMACY BULK PACKAGE ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION AND INTRALIPID® 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID® 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION (FOR EXAMPLE, THROUGH A Y-CONNECTOR).
The administration of INTRALIPID 20% and INTRALIPID 30% are contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
Exercise caution when administering INTRALIPID 20% and INTRALIPID 30% to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.
INTRALIPID 20% and INTRALIPID 30% contain no more than 25 mcg/L of aluminum. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Monitor serum triglycerides to determine the patient’s capacity to eliminate the infused fat from the circulation. Overdosage must be avoided. During long-term intravenous nutrition with INTRALIPID 20% or INTRALIPID 30%, liver function tests should be performed and therapy withdrawn if the liver becomes impaired.
Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with INTRALIPID 20% or INTRALIPID 30%.
Frequent adverse events include sepsis due to contamination of the IV catheter or vein irritation may result in thrombophlebitis by concurrently infused hypertonic solutions. These adverse reactions are inseparable for the hyperalimentation procedure with or without INTRALIPID 20% or INTRALIPID 30%. Less frequent adverse reactions reported <1% in clinical trials are: Immediate or early: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion and rarely thrombocytopenia in neonates.
Delayed: hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
The deposition of a brown pigmentation in the reticuloendothelial system called “intravenous fat pigment” has been reported. The causes and significance are unknown.
To report SUSPECTED ADVERSE REACTIONS, contact Baxter at 866-888-2472 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.