Clinoleic (Olive Oil / Soybean Oil Emulsion)

Intravenous lipid emulsion for parenteral nutrition

Prescription Only (Rx) Lipid Emulsion for Parenteral Nutrition Emulsion for Infusion
Active Ingredients
Refined olive oil (80%) + refined soybean oil (20%)
Strength
200 mg/ml
Manufacturer
Baxter Healthcare
Administration
Intravenous infusion
Reviewed by iMedic Medical Team
Published:
Updated:
Evidence Level: 1A

Clinoleic is a sterile lipid emulsion containing 80% refined olive oil and 20% refined soybean oil, used as a source of energy and essential fatty acids in parenteral (intravenous) nutrition. It is prescribed for patients who are unable to eat or receive nutrients through the gastrointestinal tract. Clinoleic is administered directly into the bloodstream through an intravenous infusion, bypassing the digestive system entirely. This medication is only available by prescription and must be administered under medical supervision in a clinical setting.

Quick Facts

Active Ingredients
Olive Oil 80% + Soybean Oil 20%
Drug Class
Lipid Emulsion
Energy Content
2000 kcal/L
Route
IV Infusion
Available Sizes
100-1000 ml
Prescription Status
Rx Only

Key Takeaways

  • Clinoleic is an intravenous lipid emulsion used for parenteral nutrition when oral or enteral feeding is not possible.
  • It contains 80% olive oil and 20% soybean oil, providing energy (2000 kcal/L) and essential fatty acids.
  • Contraindicated in patients allergic to egg, soy, or peanut protein, and in those with severe dyslipidemia or uncorrected metabolic disorders.
  • Must be administered in a healthcare setting under medical supervision with regular monitoring of triglyceride and blood glucose levels.
  • For neonates and children under 2 years, the emulsion must be protected from light exposure during administration to prevent harmful peroxide formation.

What Is Clinoleic and What Is It Used For?

Quick Answer: Clinoleic is a sterile intravenous lipid emulsion composed of 80% refined olive oil and 20% refined soybean oil. It serves as a source of energy and essential fatty acids for patients who cannot receive nutrition through their gastrointestinal tract, a method known as parenteral nutrition.

Clinoleic belongs to a class of pharmaceutical products known as intravenous lipid emulsions used in total parenteral nutrition (TPN). When patients are unable to eat or drink normally due to medical conditions, surgery, or critical illness, their bodies still require essential nutrients including fats (lipids) to maintain cellular function, hormone production, and energy balance. Clinoleic provides these vital nutrients directly through the bloodstream.

The unique formulation of Clinoleic distinguishes it from traditional lipid emulsions. While earlier products relied exclusively on soybean oil, Clinoleic uses a blend dominated by olive oil (80%), which is rich in monounsaturated fatty acids (primarily oleic acid). The remaining 20% soybean oil provides essential polyunsaturated fatty acids, specifically linoleic acid and alpha-linolenic acid, that the human body cannot synthesize on its own. This olive oil-predominant composition was developed to address concerns about the immunosuppressive effects associated with high-dose polyunsaturated fatty acid administration.

Clinoleic delivers a concentrated energy source of 2000 kcal per liter, with an osmolarity of approximately 270 mOsm/L, which is close to physiological plasma osmolarity. This near-isotonic characteristic means it can be administered through both central and peripheral venous catheters, offering flexibility in clinical settings. The pH of the emulsion ranges from 6 to 8, and its density is approximately 0.986 g/ml.

The clinical applications of Clinoleic are broad and include patients recovering from major gastrointestinal surgery, those with short bowel syndrome, patients with inflammatory bowel disease experiencing severe flares, critically ill patients in intensive care units, cancer patients undergoing aggressive treatments that impair oral intake, and premature neonates requiring nutritional support. In all these scenarios, Clinoleic forms one component of a comprehensive parenteral nutrition regimen that also includes amino acids, carbohydrates, electrolytes, vitamins, and trace elements.

According to the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines, lipid emulsions should be included in parenteral nutrition regimens for adult patients requiring intravenous feeding for more than a few days. The olive oil-based formulation of Clinoleic has been shown in clinical studies to have a more favorable effect on immune function and oxidative stress compared to pure soybean oil emulsions, making it a preferred choice in many clinical nutrition protocols.

What Should You Know Before Using Clinoleic?

Quick Answer: Before receiving Clinoleic, your healthcare provider must assess you for allergies to egg, soy, or peanut protein, and evaluate your blood lipid levels and metabolic status. The infusion must be stopped immediately if any signs of allergic reaction occur.

Clinoleic, like all intravenous medications, requires careful assessment before administration. Your medical team will conduct a thorough evaluation of your medical history, current conditions, and potential risk factors to ensure safe use. Understanding these considerations is essential for both healthcare professionals and patients who may be receiving this treatment.

Contraindications

Clinoleic must not be administered to patients in any of the following circumstances:

These contraindications are absolute, meaning there are no circumstances under which Clinoleic should be given to patients meeting these criteria. The presence of egg phospholipids as an emulsifying agent means that even patients with mild egg allergies may experience potentially severe hypersensitivity reactions. Healthcare providers must take a detailed allergy history before initiating therapy.

Warnings and Precautions

Special monitoring is required at the beginning of every intravenous infusion of Clinoleic. The infusion must be discontinued immediately if the patient develops any abnormal signs or symptoms of an allergic reaction. These warning symptoms include sweating, fever, chills, headache, skin rash, and difficulty breathing. Healthcare professionals should have appropriate emergency medications readily available whenever Clinoleic is administered.

Your healthcare provider will regularly monitor your triglyceride levels and blood glucose throughout the course of treatment. Elevated triglycerides may indicate impaired lipid clearance, which could necessitate a dose reduction or temporary discontinuation. Blood glucose monitoring is essential because hyperglycemia is a common side effect of lipid emulsions and parenteral nutrition in general.

Patients requiring parenteral nutrition are at an inherent increased risk of infection and sepsis (bloodstream infection). The intravenous catheter used for infusion provides a direct pathway for bacteria to enter the bloodstream. Strict aseptic (sterile) technique must be maintained during catheter placement, care, and when preparing the nutrition solution. Any signs of catheter-related infection, such as redness, swelling, or tenderness at the insertion site (thrombophlebitis), should be reported to the medical team immediately.

Liver disorders have been reported in patients receiving intravenous nutrition therapy. Patients should be monitored for symptoms such as nausea, vomiting, abdominal pain, and jaundice (yellowing of skin or eyes). If hepatic complications develop, the parenteral nutrition regimen may need to be adjusted or discontinued. Long-term parenteral nutrition in particular carries an increased risk of parenteral nutrition-associated liver disease (PNALD).

Your Doctor Should Know About:
  • Severe metabolic disorders affecting sugar, fat, protein, or salt metabolism
  • Severe bloodstream infection (sepsis)
  • Severe liver disease
  • Blood coagulation disorders
  • Heart attack (myocardial infarction) or heart failure
  • Kidney failure
  • Anemia (decreased red blood cells)
  • Fluid in the lungs (pulmonary edema)

Use in Children and Neonates

Clinoleic can be used in pediatric patients, including neonates, provided that treatment is carefully monitored. Clinical experience with Clinoleic in newborns extends to approximately seven days, while in older children it has been used for up to two months. The product is restricted to premature infants born after at least 28 weeks of gestation.

Critical Light Protection for Neonates:

When Clinoleic is used for neonates and children under 2 years of age, the emulsion (in bags and administration sets) must be protected from light exposure until administration is completed. Exposure to ambient light, particularly after the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can adversely affect clinical outcomes in these vulnerable patients.

Serious adverse effects, including respiratory distress leading to decreased blood oxygen levels (dyspnea) and conditions leading to increased body acidity (metabolic acidosis), have been reported in neonates and infants following rapid administration of intravenous lipid emulsions. The infusion rate must be carefully controlled in this patient population.

Drug Interactions

The olive and soybean oils contained in Clinoleic contain natural vitamin K. While this vitamin K content does not normally affect anticoagulant therapy, patients receiving blood-thinning medications such as coumarin derivatives (e.g., warfarin) should inform their healthcare provider. Vitamin K can potentially reduce the effectiveness of these anticoagulants, although the amounts present in Clinoleic are typically insufficient to cause clinically significant interactions. Nonetheless, more frequent monitoring of international normalized ratio (INR) values may be warranted during concurrent therapy.

Potential Drug Interactions with Clinoleic
Interacting Drug Type Effect Clinical Action
Warfarin / Coumarin anticoagulants Moderate Vitamin K in olive/soybean oil may reduce anticoagulant effect Monitor INR more frequently; adjust anticoagulant dose if needed
Heparin Minor Lipid emulsions may interfere with heparin activity at high concentrations Monitor aPTT; avoid mixing in same infusion line
Cyclosporine Minor Lipid emulsions may alter cyclosporine blood levels Monitor cyclosporine trough levels during concurrent use
Insulin Moderate Clinoleic may contribute to hyperglycemia, increasing insulin requirements Monitor blood glucose closely; adjust insulin dose accordingly

It is essential to inform your healthcare provider about all medications you are currently taking, have recently taken, or may take in the future. Additives must not be made directly to the Clinoleic bag. When Clinoleic is used as part of a multi-component parenteral nutrition admixture, the compatibility and stability of all components must be verified before administration.

Pregnancy and Breastfeeding

The safety of Clinoleic during pregnancy and breastfeeding has not been formally established through controlled clinical studies. As a result, Clinoleic should not be used during pregnancy or while breastfeeding unless the treating physician has made a specific determination that the potential benefits outweigh the possible risks. In clinical practice, however, parenteral nutrition including lipid emulsions may be necessary during pregnancy in cases of hyperemesis gravidarum or other conditions preventing adequate oral intake. In such circumstances, careful monitoring by a multidisciplinary team is recommended.

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should discuss this with your doctor before receiving Clinoleic. The decision to use parenteral nutrition during pregnancy must balance the nutritional needs of both the mother and the developing fetus against any potential risks associated with intravenous lipid administration.

What Is the Correct Dosage of Clinoleic?

Quick Answer: Clinoleic contains 200 mg/ml of lipids. For adults, the dose ranges from 1 to a maximum of 2 g lipids per kg body weight per day. For children, the maximum daily dose is 3 g/kg. It is administered via intravenous infusion under strict medical supervision.

The dosage of Clinoleic is individualized based on each patient's clinical condition, nutritional requirements, body weight, and metabolic capacity. Only qualified healthcare professionals should determine and adjust the dose. The concentration of Clinoleic is 200 mg/ml of lipids, providing 2000 kcal per liter of emulsion.

Adults

Adult Dosage

The physician determines the dose based on individual patient requirements. The recommended dose is 1 to a maximum of 2 grams of lipids per kilogram of body weight per day. For a 70 kg adult, this translates to 70–140 g of lipids per day, or 350–700 ml of Clinoleic per day. The infusion rate should not exceed the body's capacity to clear lipids from the bloodstream, and triglyceride levels should be monitored to confirm adequate clearance.

Children

Pediatric Dosage

For children, the recommended daily dose should not exceed 3 grams of lipids per kilogram of body weight. The infusion rate must be carefully adjusted based on the child's age, weight, and clinical condition. Healthcare providers should initiate lipid infusion at a low rate and increase gradually while monitoring tolerance.

Premature and Low Birth Weight Infants

Neonatal Dosage

The use of Clinoleic is restricted to premature infants born after at least 28 weeks of gestation. A daily dose of 2.0 g lipids/kg should not be exceeded in this population. The infusion rate must be carefully controlled, as rapid administration can cause respiratory distress and metabolic acidosis. The emulsion must be protected from light during administration.

Clinoleic Dosage Summary
Patient Group Maximum Daily Dose Special Considerations
Adults 1–2 g lipids/kg/day Dose based on individual needs; monitor triglycerides
Children Up to 3 g lipids/kg/day Careful monitoring; gradual rate titration
Premature Infants (≥28 weeks) Up to 2 g lipids/kg/day Light protection required; slow infusion rate
Elderly 1–2 g lipids/kg/day Consider reduced clearance; monitor hepatic/renal function

Route of Administration

Clinoleic is administered exclusively by intravenous infusion through a plastic catheter and needle inserted directly into a vein. The emulsion can be infused through either a central venous catheter or a peripheral venous catheter, depending on the osmolarity of the total parenteral nutrition admixture and the expected duration of therapy. Central venous access is generally preferred for long-term parenteral nutrition, while peripheral access may be suitable for short-term use.

Lipids represent only one component of parenteral nutrition. For complete parenteral nutrition, simultaneous supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is required. The compatibility and stability of all components must be verified before administration to the patient. When preparing admixtures, strict aseptic technique must be followed.

Overdose

An overdose of Clinoleic can cause a decrease in the body's ability to clear lipids from the bloodstream, a condition known as fat overload syndrome. In neonates and infants, overdose and/or rapid administration of lipid emulsions can cause serious adverse effects including respiratory distress leading to decreased blood oxygen levels (dyspnea) and metabolic acidosis (increased body acidity). These effects typically reverse when the infusion of Clinoleic is discontinued.

Fat overload syndrome is characterized by a sudden deterioration in the patient's general condition and may present with excessively high blood lipid levels, fever, fatty infiltration of the liver, hepatomegaly (enlarged liver), anemia, decreased white blood cells and platelets, blood coagulation problems, and in severe cases, coma. If overdose is suspected, the infusion should be stopped immediately and supportive care provided.

Missed Dose

Since Clinoleic is administered by healthcare professionals in a clinical setting, missed doses are uncommon. If a scheduled infusion is inadvertently missed, it should not be compensated by doubling the next dose. The healthcare team will resume the normal dosing schedule at the next scheduled administration time. If you have concerns about a missed infusion, consult your healthcare provider.

What Are the Side Effects of Clinoleic?

Quick Answer: Common side effects of Clinoleic include elevated blood sugar (hyperglycemia), nausea, vomiting, and low blood pressure. Uncommon side effects include decreased white blood cells, breathing difficulties, and elevated liver enzymes. Stop the infusion immediately if allergic symptoms such as sweating, chills, or difficulty breathing occur.

Like all medicines, Clinoleic can cause side effects, although not everyone who receives it will experience them. The risk and severity of side effects depend on factors including the infusion rate, dose, duration of therapy, and the patient's underlying medical condition. Healthcare professionals should be aware of the following adverse reactions and monitor patients accordingly.

If any abnormal changes are noticed at the beginning of the infusion, the infusion must be stopped immediately. Warning symptoms that necessitate immediate discontinuation include sweating, chills, headache, and difficulty breathing. These may indicate a hypersensitivity reaction that could progress to a more serious allergic event if the infusion continues.

Common Side Effects

Affects 1 to 10 in every 100 patients

  • Hyperglycemia (elevated blood sugar levels)
  • Nausea
  • Vomiting
  • Hypotension (low blood pressure)

Uncommon Side Effects

Affects 1 to 10 in every 1,000 patients

  • Leukopenia (decreased white blood cell count)
  • Dyspnea (breathing difficulties)
  • Abdominal distension or pain and discomfort in the stomach area
  • Cholestasis (jaundice caused by gallbladder problems) or elevated bilirubin levels
  • Elevated liver enzyme levels
  • Elevated triglyceride levels in the blood

Frequency Unknown

Cannot be estimated from available data

  • Thrombocytopenia (decreased platelet count)
  • Chills
  • Allergic reactions including urticaria (red, itchy skin rash) and pruritus (itching)
  • Diarrhea

Fat Overload Syndrome

In patients with impaired ability to clear lipids from the bloodstream, a serious condition called fat overload syndrome may develop. This syndrome can result from an overdose of Clinoleic but may also occur at the beginning of an infusion even when Clinoleic is administered according to instructions. Fat overload syndrome is associated with a sudden deterioration in the patient's overall condition and can present with the following signs and symptoms:

  • Excessively high blood lipid levels (hyperlipidemia)
  • Fever
  • Fatty infiltration of the liver (hepatic steatosis)
  • Hepatomegaly (enlarged liver)
  • Anemia (decreased red blood cells)
  • Leukopenia and thrombocytopenia (decreased white blood cells and platelets)
  • Coagulopathy (problems with blood clotting)
  • Deep coma (in severe cases)

All of these symptoms typically resolve when the infusion is discontinued. If fat overload syndrome is suspected, the Clinoleic infusion should be stopped immediately, and the patient should receive appropriate supportive care. Monitoring of triglyceride levels throughout therapy can help detect early signs of impaired lipid clearance before the full syndrome develops.

Reporting Side Effects

It is important to report suspected adverse reactions after a medicine has been authorized, as this enables continuous monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected side effects to their national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, or the EMA in the European Union).

How Should You Store Clinoleic?

Quick Answer: Store Clinoleic at or below 25°C (77°F). Do not freeze. Keep in the outer pouch and original packaging. Use immediately after opening. Discard any unused portion.

Proper storage of Clinoleic is essential to maintain the integrity, sterility, and efficacy of the emulsion. Inappropriate storage conditions can cause the emulsion to separate, degrade, or become contaminated, all of which could pose serious risks to patient safety. The following storage guidelines must be strictly followed:

  • Temperature: Store at or below 25°C (77°F). The product must not be exposed to excessive heat or direct sunlight.
  • Freezing: Do not freeze Clinoleic under any circumstances. Freezing can irreversibly damage the emulsion structure.
  • Packaging: Keep the product in its outer protective pouch and original packaging. The product is moisture-sensitive and must be protected from humidity.
  • Expiration: Do not use after the expiration date printed on the label (marked as EXP). The expiration date refers to the last day of the indicated month.
  • Oxygen indicator: An oxygen-absorbing sachet and oxygen indicator are placed inside the outer pouch. Before opening the outer pouch, check that the color of the oxygen indicator matches the reference color next to the OK symbol on the indicator label. Do not use the product if the colors do not match.
  • After opening: Use immediately. Do not save an opened bag for later use. Partially used bags must be discarded.
  • Visual inspection: Do not use Clinoleic if the packaging is damaged or if the emulsion does not appear homogeneously milky white. Any signs of particulates, discoloration, or phase separation indicate that the product should not be used.

Keep all medications out of the sight and reach of children. Healthcare professionals are responsible for the proper handling and disposal of unused medication and all associated materials, in accordance with local regulations for pharmaceutical waste management.

Light Protection for Neonatal Use

When using Clinoleic for neonates and children under 2 years of age, the emulsion in bags and administration sets must be protected from light exposure until administration is completed. Light exposure, particularly after the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light.

What Does Clinoleic Contain?

Quick Answer: Clinoleic contains refined olive oil (80%) and refined soybean oil (20%) as active ingredients, providing 20 g of lipids per 100 ml with approximately 4 g of essential fatty acids. Excipients include egg phospholipids, glycerol, sodium oleate, sodium hydroxide, and water for injection.

Understanding the full composition of Clinoleic is important for healthcare professionals to assess potential allergenicity, nutritional contribution, and compatibility with other medications and nutrition components.

Active Ingredients (per 100 ml)

Clinoleic Composition per 100 ml
Component Amount
Refined olive oil (80%) and refined soybean oil (20%) 20.00 g
Essential fatty acid content 4.00 g
Energy content 2000 kcal/L (8.36 MJ/L)
Osmolarity 270 mOsm/L
pH 6–8
Density 0.986 g/ml
Phosphorus (from phospholipids) 47 mg (1.5 mmol) per 100 ml

Excipients (Inactive Ingredients)

The inactive ingredients in Clinoleic serve essential pharmaceutical functions including emulsification, pH adjustment, and isotonicity:

  • Egg phospholipids: Act as the primary emulsifying agent to maintain the oil-in-water emulsion structure. Patients with egg allergy must not receive this product.
  • Glycerol: Serves as an isotonicity agent to bring the osmolarity close to that of blood plasma.
  • Sodium oleate: Functions as a co-emulsifier to stabilize the emulsion.
  • Sodium hydroxide: Used for pH adjustment to maintain the emulsion within the acceptable pH range of 6–8.
  • Water for injections: The aqueous phase of the emulsion, meeting pharmacopeial standards for sterile water.

Appearance and Available Sizes

Clinoleic is a milky, homogeneous liquid supplied in plastic bags. The following bag sizes are available, although not all sizes may be marketed in every country:

  • 100 ml: available in packs of 1, 10, or 24 bags
  • 250 ml: available in packs of 1, 10, or 20 bags
  • 350 ml: available in packs of 1, 10, or 12 bags
  • 500 ml: available in packs of 1, 10, or 12 bags
  • 1000 ml: available in packs of 6 bags

The product is for single use only. Once opened, the contents must be used immediately. Any remaining emulsion must not be reused and should be disposed of by healthcare personnel according to local pharmaceutical waste regulations. Do not reconnect partially used bags, as there is a risk of air embolism due to residual air in the primary bag.

How Is Clinoleic Prepared and Administered?

Quick Answer: Clinoleic is for single use only. Open the outer protective pouch, discard the oxygen absorber, verify bag integrity and emulsion appearance, then hang the bag and insert the infusion spike. Additives must not be made directly to the bag.

The following information is intended for healthcare professionals responsible for the preparation and administration of Clinoleic. Proper handling is critical to maintain the sterility and stability of the product.

Preparation Steps

  1. Open: Tear apart the protective outer pouch. Discard the oxygen absorber and indicator.
  2. Inspect: Verify that the bag is undamaged and the lipid emulsion is a homogeneous liquid with a milky-white appearance. Do not use if particles or clumps are observed.
  3. Hang: Suspend the bag on the IV pole.
  4. Connect: Remove the plastic cap from the administration port and firmly insert the infusion spike into the administration port.

Important Administration Notes

  • The contents must be used immediately after the bag is opened. Never save an opened bag for later infusion.
  • Do not connect bags in series, as there is a risk of air embolism from residual air in the primary bag.
  • Additives must not be made directly to the Clinoleic bag. When Clinoleic is used as part of a multi-component parenteral nutrition admixture, component compatibility and mixture stability must be confirmed before administration.
  • Addition of supplements should be followed by gentle mixing during preparation and must only be performed under strictly aseptic conditions.
  • Unused medication, waste, and all associated instruments should be disposed of in accordance with local regulations.
  • For neonates and children under 2 years, protect the product from light until administration is completed.

Frequently Asked Questions About Clinoleic

Clinoleic is an intravenous lipid emulsion used as part of parenteral nutrition (feeding through a vein). It provides energy and essential fatty acids to patients who cannot eat or receive nutrition through their gastrointestinal tract. This may include patients recovering from major surgery, those with severe gastrointestinal disorders, critically ill patients in intensive care, cancer patients unable to eat due to treatment side effects, and premature neonates. It is always administered under medical supervision in a hospital or clinical setting.

Clinoleic must not be administered to patients with known allergies to egg, soy, or peanut protein, as it contains egg phospholipids and soybean oil. Cross-allergic reactions between soybean and peanut protein have been documented. It is also contraindicated in patients with severe dyslipidemia (very high blood fat levels) and those with uncorrected metabolic disorders such as lactic acidosis or uncontrolled diabetes mellitus. Your healthcare provider will assess these factors before prescribing Clinoleic.

Unlike traditional intravenous lipid emulsions that use 100% soybean oil, Clinoleic contains 80% olive oil and only 20% soybean oil. This olive oil-predominant formulation provides mainly monounsaturated fatty acids (oleic acid) rather than polyunsaturated fatty acids. Clinical research suggests that this composition may have a more favorable effect on immune function and oxidative stress compared to pure soybean oil emulsions, as high levels of polyunsaturated fatty acids have been associated with immunosuppressive effects. The olive oil component also helps reduce the ratio of omega-6 to omega-3 fatty acids in the formulation.

The duration of Clinoleic therapy depends entirely on the patient's clinical condition and is determined by the treating physician. Some patients may only need short-term parenteral nutrition for a few days following surgery, while others with chronic conditions such as short bowel syndrome may require long-term or even lifelong parenteral nutrition. In neonates, Clinoleic has been used for up to seven days, and in older children for up to two months. Throughout therapy, regular monitoring of blood lipid levels, liver function, and overall metabolic status is essential to detect any complications early.

The safety of Clinoleic during pregnancy and breastfeeding has not been formally established through controlled clinical trials. Therefore, it should only be used during pregnancy or while breastfeeding if the prescribing physician determines that the potential benefits justify the potential risks to both mother and child. In clinical practice, parenteral nutrition including lipid emulsions may sometimes be necessary during pregnancy in cases such as severe hyperemesis gravidarum or other conditions that prevent adequate oral nutrition. In these situations, careful multidisciplinary monitoring is essential.

When lipid emulsions like Clinoleic are exposed to ambient light, particularly after the addition of trace elements and/or vitamins, photochemical reactions generate peroxides and other potentially harmful degradation products. Neonates and young children under 2 years of age are especially vulnerable to these compounds due to their immature antioxidant defense systems. Clinical studies have shown that light protection during administration can significantly reduce peroxide generation and improve clinical outcomes. Therefore, the emulsion in bags and administration sets must be shielded from light during the entire infusion period for these patients.

References

This article is based on the following peer-reviewed sources and international medical guidelines:

  1. European Medicines Agency (EMA). Clinoleic Summary of Product Characteristics. EMA Product Database. Available at: www.ema.europa.eu
  2. Singer P, Blaser AR, Berger MM, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clinical Nutrition. 2019;38(1):48-79. doi:10.1016/j.clnu.2018.08.037
  3. Calder PC, Adolph M, Deutz NE, et al. Lipids in the intensive care unit: recommendations from the ESPEN Expert Group. Clinical Nutrition. 2018;37(1):1-18. doi:10.1016/j.clnu.2017.08.032
  4. Driscoll DF, Bistrian BR, Demmelmair H, Koletzko B. Pharmaceutical and clinical aspects of parenteral lipid emulsions in neonatology. Clinical Nutrition. 2008;27(4):497-503. doi:10.1016/j.clnu.2008.05.003
  5. Goulet O, Anteby SO, Bhatti F, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Lipids. Clinical Nutrition. 2018;37(6 Pt B):2324-2336. doi:10.1016/j.clnu.2018.06.946
  6. World Health Organization (WHO). WHO Model Formulary: Parenteral Nutrition. WHO Essential Medicines. Available at: www.who.int
  7. Reimund JM, Rahmi G, Escalin G, et al. Efficacy and safety of an olive oil-based intravenous fat emulsion (ClinOleic) in chronic intestinal failure. Alimentary Pharmacology & Therapeutics. 2005;21(6):721-729. doi:10.1111/j.1365-2036.2005.02354.x
  8. Waitzberg DL, Torrinhas RS, Jacintho TM. New parenteral lipid emulsions for clinical use. Journal of Parenteral and Enteral Nutrition. 2006;30(4):351-367. doi:10.1177/0148607106030004351
  9. Baxter Healthcare. Clinoleic 200 mg/ml Emulsion for Infusion — Prescribing Information. Current version.
  10. American Society for Parenteral and Enteral Nutrition (ASPEN). Safe Practices for Parenteral Nutrition. Journal of Parenteral and Enteral Nutrition. 2004;28(6):S39-S70.

About This Article

This article was prepared by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in clinical nutrition, pharmacology, and critical care medicine. All content has been reviewed according to international medical guidelines, including those published by ESPEN (European Society for Clinical Nutrition and Metabolism), ASPEN (American Society for Parenteral and Enteral Nutrition), and the WHO.

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All pharmaceutical information is verified against official product labeling, peer-reviewed clinical studies, and current international guidelines. Our editorial process follows the GRADE evidence framework to ensure the highest quality of medical information.

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