Pedismof (Pediatric Lipid Emulsion 20%)
Four-oil balanced intravenous lipid emulsion for parenteral nutrition in neonates, infants, children, and adolescents
Pedismof is a specialized four-oil intravenous lipid emulsion developed for pediatric parenteral nutrition. It combines soybean oil, medium-chain triglycerides (MCT), refined olive oil, and fish oil in proportions optimized for the metabolic and developmental needs of newborn infants, children, and adolescents. Pedismof provides essential fatty acids, concentrated energy, and the long-chain omega-3 fatty acids EPA and DHA, supporting growth, brain development, and immune function in patients who cannot be fed orally or enterally.
Quick Facts
Key Takeaways
- Pedismof is a pediatric intravenous lipid emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil, specifically formulated for newborn infants, children, and adolescents.
- The balanced four-oil composition reduces the high omega-6 load of pure soybean oil emulsions and supplies long-chain omega-3 fatty acids (EPA and DHA) that support brain and retinal development.
- It is contraindicated in patients allergic to fish, egg, soybean, or peanut protein, as well as in severe hyperlipidemia, severe hepatic insufficiency, or unstable clinical conditions.
- Dosing is weight-based and age-specific: typically 0.5-3.0 g lipid/kg/day in children and adolescents, with a slower initial titration in preterm neonates.
- Regular monitoring of serum triglycerides, liver function, coagulation parameters, electrolytes, and growth is essential throughout therapy to prevent fat overload syndrome and parenteral nutrition-associated liver disease (PNALD).
What Is Pedismof and What Is It Used For?
Pedismof is a sterile, white-to-yellowish oil-in-water lipid emulsion administered intravenously as part of total or supplemental parenteral nutrition. It was developed to address the specific metabolic, developmental, and clinical requirements of pediatric patients, whose nutritional needs differ substantially from those of adults. The formulation is based on the well-established SMOF concept (Soybean oil, MCT, Olive oil, Fish oil) but refined for children, with adjusted fatty-acid proportions and antioxidant content that reflect contemporary pediatric parenteral nutrition guidelines.
The active lipid fraction of Pedismof provides a concentrated source of energy (approximately 2 kcal per mL in the 20% formulation) together with a physiologic spectrum of fatty acids. Soybean oil contributes the essential fatty acids linoleic acid (omega-6) and alpha-linolenic acid (omega-3). Medium-chain triglycerides (MCT), derived from coconut or palm kernel oil, are rapidly oxidized in mitochondria without requiring carnitine, making them an efficient energy substrate for critically ill children. Refined olive oil supplies monounsaturated oleic acid, which modulates the omega-6 load and appears to be metabolically favorable. Fish oil is the source of the long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which play critical roles in brain and retinal development, membrane fluidity, and resolution of inflammation.
In clinical practice, Pedismof is indicated as a source of energy and essential fatty acids for newborn infants, including preterm neonates, infants, young children, and adolescents when oral or enteral feeding is impossible, insufficient, or contraindicated. Typical clinical situations include congenital gastrointestinal disorders such as gastroschisis, intestinal atresia, or necrotizing enterocolitis; short bowel syndrome after extensive intestinal resection; severe malabsorption syndromes; prolonged postoperative ileus; chemotherapy-induced mucositis with severe oral intake failure; critical illness with intolerance of enteral nutrition; and intestinal failure of any cause requiring long-term parenteral nutrition support.
Beyond its role as a caloric substrate, Pedismof is used strategically to modify the fatty acid profile delivered to the growing child. The inclusion of fish oil is particularly important in pediatric parenteral nutrition. Long-term use of pure soybean oil emulsions has been associated with an increased incidence of parenteral nutrition-associated liver disease (PNALD, also called intestinal failure-associated liver disease or IFALD), especially in preterm neonates and infants with short bowel syndrome. Mixed emulsions containing fish oil have been shown in clinical studies to reduce the risk and severity of cholestasis and may even reverse established PNALD in some patients. Pedismof therefore represents a pharmacologically active nutritional strategy, not merely a source of calories.
Pedismof is delivered in the context of a broader parenteral nutrition regimen that also includes amino acids, carbohydrates (glucose), electrolytes, trace elements, and vitamins. Depending on the compounding capabilities of the treating institution, Pedismof may be infused as a separate lipid component or admixed with amino acids and glucose to form an "all-in-one" or "three-in-one" parenteral nutrition bag. In neonatal and pediatric intensive care, the emulsion is generally administered through a central venous catheter to allow precise control of infusion rates and safe co-infusion with other concentrated parenteral nutrition components.
What Should You Know Before a Child Receives Pedismof?
Pedismof is a hospital-administered medication prescribed only by physicians with experience in pediatric parenteral nutrition, usually in neonatal intensive care, pediatric intensive care, or specialist pediatric gastroenterology units. Prior to initiating therapy, the treating team undertakes a detailed assessment of the child's underlying condition, nutritional requirements, organ function, and individual risk factors. Understanding the contraindications and precautions helps parents and caregivers recognize why certain decisions are made during their child's care.
Contraindications
Pedismof must not be administered to patients with any of the following conditions:
- Hypersensitivity to fish, egg, soybean, or peanut protein: The emulsion contains soybean oil, fish oil, and egg yolk phospholipids as an emulsifier. Cross-reactivity between soybean and peanut is well documented. Known or suspected allergy to any of these substances or to any excipient is an absolute contraindication.
- Severe hyperlipidemia or pathological disturbance of lipid metabolism: Including severe hypertriglyceridemia, which increases the risk of fat overload syndrome and pancreatitis.
- Severe hepatic insufficiency: Significant liver dysfunction impairs clearance of lipid particles and may worsen cholestasis.
- Severe blood coagulation disorders: Active bleeding tendencies must be controlled before lipid emulsion is added to the regimen.
- Severe renal insufficiency without access to hemofiltration or dialysis: Lipid clearance may be impaired in uremia.
- Acute thromboembolic events or severe shock: Hemodynamic instability must be corrected first.
- Acute phase of cardiac infarction or stroke: Lipid administration is generally deferred until the acute phase resolves.
- Unstable clinical conditions: Including uncontrolled acidosis, severe sepsis, or multi-organ failure.
- General contraindications to parenteral nutrition: Including unstable circulation or acute pulmonary edema, hyperhydration, and decompensated diabetes mellitus.
Warnings and Precautions
Several clinical scenarios require enhanced monitoring, dose adjustment, or a more cautious infusion protocol when Pedismof is used. Children with disturbances of lipid metabolism, sepsis, or metabolic acidosis may clear triglycerides less efficiently than healthy children and require slower infusion rates with frequent laboratory checks. Patients with impaired renal function, especially in the neonatal period, may accumulate lipid-soluble degradation products and should be monitored closely.
Because the emulsion contains fish oil, bleeding time may be prolonged and platelet aggregation reduced in children receiving prolonged or high-dose therapy, particularly those concurrently receiving antithrombotic drugs. Coagulation parameters including prothrombin time, activated partial thromboplastin time, and platelet count should be checked before starting therapy and at regular intervals. In preterm neonates, the immature antioxidant defenses mean that exposure to light during infusion can generate lipid hydroperoxides; light protection of the infusion line is recommended wherever feasible.
Infants, especially those with very low birth weight, are at higher risk of hypertriglyceridemia and fat overload. In this population, Pedismof is introduced at a conservative starting dose with gradual, protocol-driven up-titration over several days. Jaundiced neonates require particular attention, as unbound bilirubin competes with free fatty acids for albumin binding sites; excessive lipid infusion in the presence of severe hyperbilirubinemia may theoretically increase the risk of kernicterus and is generally avoided.
Long-term pediatric parenteral nutrition with any lipid emulsion carries a risk of intestinal failure-associated liver disease. Although the composition of Pedismof, including its fish oil content, may reduce this risk relative to pure soybean emulsions, the risk is not eliminated. Children on prolonged therapy require structured liver surveillance including liver function tests, bile acids, and, when appropriate, imaging. Cyclic (less than 24-hour) infusion of parenteral nutrition and, wherever possible, some enteral feeding are recommended to reduce hepatic complications.
Fat overload syndrome is a rare but potentially life-threatening complication of excessive or too-rapid lipid infusion. Features include hyperlipidemia, fever, hepatomegaly, splenomegaly, jaundice, anemia, leukopenia, thrombocytopenia, coagulation disorders, and in severe cases, coma and multi-organ failure. If any of these features appear, Pedismof must be stopped immediately. Fat overload syndrome is usually reversible once the infusion is discontinued and supportive care provided.
Pregnancy, Breastfeeding, and Fertility
Pedismof is primarily a pediatric medicine, and clinical use in pregnancy and lactation is not the main indication. Nevertheless, in rare situations where a pregnant or breastfeeding adolescent requires parenteral nutrition, the emulsion may be used when medically justified and under specialist supervision. The essential fatty acids, medium-chain triglycerides, and long-chain omega-3 fatty acids in Pedismof are physiological components of normal nutrition and are not expected to be teratogenic, but no controlled studies have been performed in pregnancy.
During breastfeeding, the fatty acids supplied by Pedismof are structurally identical or closely related to those present in human milk, and maternal intravenous lipid supplementation is not expected to adversely affect infant feeding. Clinical decisions in both pregnancy and lactation should be individualized and made in consultation with obstetric, pediatric, and nutrition specialists. In non-pregnant adolescents, no effects on fertility have been reported.
How Does Pedismof Interact with Other Drugs?
Drug interactions with intravenous lipid emulsions become clinically relevant mainly in critically ill pediatric patients who receive multiple concurrent therapies. The lipid fraction of Pedismof can alter the distribution and clearance of other drugs, influence laboratory test results, and be physically incompatible with certain medications if co-administered through the same intravenous line. Awareness of these interactions is essential for safe prescribing and for the bedside management of neonatal and pediatric intensive care patients.
The most clinically significant pharmacodynamic interaction relates to the fish oil component. Long-chain omega-3 fatty acids can reduce platelet aggregation and mildly prolong bleeding time. In children who are also receiving antithrombotic medications, such as heparin, low-molecular-weight heparins, warfarin, or coumarin anticoagulants, coagulation parameters should be monitored more closely than usual, and dose adjustments of the anticoagulant may be required. The clinical impact is usually modest at standard lipid doses but can become relevant during prolonged therapy or when high omega-3 doses are administered.
Major Interactions
| Drug or Drug Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| Heparin & LMWH | Release of lipoprotein lipase by heparin can transiently alter lipid clearance and coagulation parameters | High | Monitor aPTT, anti-Xa, and triglycerides; adjust anticoagulant dose as needed |
| Warfarin & coumarin anticoagulants | Fish oil omega-3 fatty acids may potentiate anticoagulant effect and prolong bleeding time | High | Monitor INR more frequently; adjust anticoagulant dose; consider risk in children on long-term therapy |
| Cyclosporine & tacrolimus | Lipid emulsions can bind lipophilic immunosuppressants and alter free-drug concentration | High | Measure trough levels; adjust immunosuppressant dose under specialist guidance |
| Insulin | Lipid and glucose co-infusion can modify insulin sensitivity and glycemic control | Moderate | Frequent blood glucose monitoring; tailor insulin infusion to total PN delivery |
| Propofol (lipid vehicle) | Propofol is formulated in a lipid emulsion; concurrent Pedismof adds to total lipid load | Moderate | Include propofol lipid content when calculating total daily lipid intake |
| Amphotericin B lipid complex | Both products contain lipid carriers; simultaneous administration may affect stability | Moderate | Administer through separate IV lines unless compatibility is formally established |
Minor Interactions and Laboratory Interference
Pedismof can cause clinically relevant interference with laboratory tests, particularly in small children from whom blood samples are drawn frequently. The turbid, lipemic appearance of plasma during and shortly after lipid infusion affects spectrophotometric assays. Serum bilirubin, lactate dehydrogenase (LDH), hemoglobin, electrolytes measured by indirect ion-selective electrode, and some immunoassays can all be distorted by lipemia. Pulse oximetry readings can also be affected in severe lipemia due to changes in light absorption properties of blood.
To minimize laboratory interference, blood samples should ideally be taken before the lipid infusion is started or at least 5 to 6 hours after the emulsion has been fully infused, allowing for clearance of circulating particles. When urgent testing is required during continuous infusion, laboratory staff should be informed so that lipemia-compatible methodologies or corrective calculations can be used.
Certain electrolytes and additives are physically incompatible with lipid emulsions. Divalent cations such as calcium and magnesium in high concentrations can destabilize the emulsion by neutralizing the negative surface charge of the lipid droplets, leading to droplet aggregation and, ultimately, visible phase separation or "cracking." Strict compatibility guidelines must therefore be followed when compounding all-in-one parenteral nutrition bags or when adding medications to an infusion containing Pedismof. Many antibiotics, antifungals, and electrolyte concentrates should be administered through a separate IV line unless pharmacy compatibility data exists.
Never add medications or electrolyte concentrates directly to Pedismof or to a co-infusing parenteral nutrition bag without explicit compatibility documentation. When in doubt, use a separate lumen or IV line. Hospital pharmacy and parenteral nutrition teams maintain compatibility references specific to each product combination.
What Is the Correct Dosage of Pedismof?
Pedismof dosing is always individualized. The prescribing physician, typically in collaboration with a pediatric clinical nutrition team or pharmacist, determines the daily dose based on the child's age, weight, clinical condition, growth requirements, and the proportion of total energy that should be delivered as fat. In a comprehensive parenteral nutrition regimen, lipids usually provide 25-40% of total non-protein calories, with the remainder supplied as glucose. The guidelines below are based on the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), ESPEN, ESPR, and CSPEN joint pediatric parenteral nutrition recommendations, and should always be adapted to the individual patient.
Preterm and Term Neonates
Neonatal Dosing - Pedismof 20%
Starting dose (preterm): 0.5-1.0 g lipid/kg/day on day 1 of life or at initiation
Advancement: Increase by 0.5-1.0 g/kg/day as tolerated
Target dose: 2.5-3.5 g/kg/day
Maximum dose: Should not routinely exceed 4 g/kg/day in preterm infants
Maximum infusion rate: 0.15 g lipid/kg/hour (approximately 0.75 mL/kg/hour of 20%)
Early lipid initiation within 24 hours of birth is now recommended in preterm infants to prevent essential fatty acid deficiency, which can develop within days in this population.
Infants, Children, and Adolescents
Pediatric Dosing (beyond neonatal period) - Pedismof 20%
Infants (<1 year): Starting dose 1-2 g/kg/day, target 2-3 g/kg/day
Children (1-10 years): 1-3 g/kg/day depending on clinical status
Adolescents (>10 years): 1-2 g/kg/day, maximum 3 g/kg/day
Maximum infusion rate: 0.15 g/kg/hour in infants; 0.13 g/kg/hour in older children
Children recovering from burns, major surgery, or severe infections may require the upper end of the dose range to meet increased energy demands. The proportion of calories from fat should generally remain between 25% and 40% of total non-protein calories.
| Patient Group | Starting Dose (g lipid/kg/day) | Target Dose | Max Infusion Rate | Special Considerations |
|---|---|---|---|---|
| Preterm neonates | 0.5-1.0 g/kg/day | 2.5-3.5 g/kg/day | 0.15 g/kg/hour | Early initiation; monitor bilirubin and triglycerides daily |
| Term neonates | 1.0-2.0 g/kg/day | 2.5-3.5 g/kg/day | 0.15 g/kg/hour | Cycle PN where possible; avoid excessive glucose load |
| Infants (<1 year) | 1.0-2.0 g/kg/day | 2.0-3.0 g/kg/day | 0.15 g/kg/hour | Follow growth and liver function regularly |
| Children (1-10 years) | 1.0-2.0 g/kg/day | 1.0-3.0 g/kg/day | 0.13 g/kg/hour | Individualize to growth, activity, and illness severity |
| Adolescents | 1.0 g/kg/day | 1.0-2.0 g/kg/day | 0.13 g/kg/hour | Transition to adult-type regimens when appropriate |
Route and Practical Administration
Pedismof is administered by intravenous infusion, generally through a central venous catheter to accommodate the osmolality of the complete parenteral nutrition regimen. Short-term peripheral administration of the lipid emulsion alone may be acceptable in selected situations, but compounded three-in-one parenteral nutrition bags typically require central access. The emulsion can be infused as a separate component in parallel with amino acids and glucose ("multi-bottle system"), or mixed with other components into an all-in-one bag by a hospital pharmacy following validated compatibility data.
The infusion is started at a low rate and advanced gradually to allow the child's metabolism to adapt. Infusion should ideally be continuous over 18-24 hours, although cyclic infusion (less than 24 hours) is frequently used in children on long-term parenteral nutrition to promote liver health and improve quality of life. Light protection of the infusion line is recommended, particularly in neonates, to reduce lipid peroxidation.
Missed or Delayed Dose
Because Pedismof is administered in a controlled hospital environment under nursing and medical supervision, missed doses are managed by the healthcare team. If a scheduled infusion is delayed due to line access problems, equipment issues, or clinical deterioration, the physician decides whether to resume the planned dose or adjust the 24-hour total. The infusion rate must never be arbitrarily increased to "catch up" on missed volume, as this can precipitate fat overload.
Overdose
Overdose with Pedismof, whether from excessive rate or excessive total daily dose, can lead to fat overload syndrome. The clinical picture includes marked hyperlipidemia, fever, hepatomegaly, splenomegaly, jaundice, anemia, leukopenia, thrombocytopenia, prolonged clotting times, and, in severe cases, coma and multi-organ failure. There is no specific antidote. Management consists of immediately stopping the lipid infusion, providing supportive care, and closely monitoring hepatic, renal, and hematologic parameters. In most cases, the syndrome resolves once the infusion is discontinued. In very severe cases, plasma exchange may be considered.
What Are the Side Effects of Pedismof?
Like all medicines, Pedismof can cause side effects, although not every child will experience them. Because Pedismof is used almost exclusively in hospitalized children with complex underlying conditions, it is sometimes difficult to separate adverse events caused by the lipid emulsion itself from those caused by the underlying illness, concurrent medications, or the parenteral nutrition regimen as a whole. The side effects listed below are based on pooled clinical trial data, post-marketing surveillance, and international pediatric parenteral nutrition registries.
The frequency and severity of adverse events are usually related to the infusion rate, the total daily dose, and the duration of therapy. Most reactions are mild and transient, resolving when the infusion rate is reduced or the infusion is temporarily stopped. Serious reactions such as anaphylaxis or fat overload syndrome are rare but require immediate discontinuation and specialist management.
Common
May affect up to 1 in 10 patients
- Transient increase in serum triglycerides
- Mild elevation of liver enzymes (ALT, AST, alkaline phosphatase, GGT)
- Nausea or vomiting
- Transient elevation of body temperature during infusion
- Headache (in older children and adolescents)
- Feeling of warmth during infusion
Uncommon
May affect up to 1 in 100 patients
- Abdominal pain or discomfort
- Thrombophlebitis at the infusion site (more common with peripheral access)
- Chills or shivering during infusion
- Tachycardia (increased heart rate)
- Dyspnea (shortness of breath)
- Chest or back pain
- Hypertension or hypotension
Rare
May affect up to 1 in 1,000 patients
- Hypersensitivity reactions including skin rash, urticaria, and bronchospasm
- Anaphylactic reactions in children allergic to fish, egg, soy, or peanut
- Fat overload syndrome (hyperlipidemia, fever, hepatosplenomegaly, coagulopathy)
- Hemolytic anemia
- Priapism (reported with other lipid emulsions, by analogy)
- Pancreatitis in the setting of severe hypertriglyceridemia
Long-Term (>4 Weeks of Continuous Therapy)
Observed mainly in prolonged pediatric parenteral nutrition
- Parenteral nutrition-associated liver disease (PNALD) / intestinal failure-associated liver disease (IFALD)
- Cholestasis with conjugated hyperbilirubinemia
- Hepatic steatosis detectable on imaging
- Essential fatty acid deficiency if lipid dose is too low or interrupted
- Micronutrient imbalances requiring additional supplementation
Parenteral nutrition-associated liver disease (PNALD) deserves special mention in pediatric practice. It is the most important long-term complication of prolonged intravenous nutrition in children, especially in preterm infants and those with short bowel syndrome. Risk factors include excessive soybean-oil-based lipid doses, absence of enteral feeding, repeated sepsis episodes, prematurity, and very young age. The fish oil component of Pedismof, rich in omega-3 fatty acids, appears to reduce the incidence and severity of PNALD compared with pure soybean oil emulsions, and there is growing evidence that mixed or fish-oil-based lipids can reverse established cholestasis in selected children with intestinal failure.
Infusion-site reactions are more common with peripheral venous administration and with prolonged infusion through a single vein. If redness, pain, swelling, or hardening develops along the vein, the infusion site should be changed. Thrombophlebitis is less likely with central venous administration, which is the preferred route in neonatal and pediatric intensive care.
Parents and caregivers should immediately inform the nursing staff or the treating physician if they observe any of the following: sudden difficulty breathing, a new skin rash, severe abdominal pain, persistent high fever, new jaundice, unusual bruising or bleeding, excessive sleepiness, or any sudden change in the child's condition during or shortly after the infusion. These may represent rare but serious adverse reactions that require urgent medical review.
How Should Pedismof Be Stored?
As a hospital-use product, Pedismof is typically stored and prepared by the pharmacy department under validated conditions, but a general understanding of storage requirements helps all healthcare professionals involved in neonatal and pediatric parenteral nutrition preparation and administration. Proper storage is critical to maintaining the physical stability of the emulsion and the chemical integrity of its fatty acid components.
Unopened containers of Pedismof should be stored at room temperature, ideally below 25°C (77°F), in their outer carton to protect from light. The product must not be frozen. Freezing disrupts the lipid droplet structure and causes irreversible phase separation, even if the appearance seems to normalize after thawing; any product that has been frozen must be discarded. The shelf-life printed on the container assumes storage under manufacturer-recommended conditions; expired product must never be used.
Once the container is opened or transferred to an infusion set, the emulsion provides a potentially rich growth medium for bacteria and fungi, so strict aseptic technique is required throughout preparation and administration. Pedismof should preferably be used immediately after opening. If this is not possible, the product must be used within 24 hours of opening and stored at 2-8°C (36-46°F) during that period. Local hospital pharmacy protocols may specify additional handling rules based on validated compatibility data.
When Pedismof is admixed with amino acids, glucose, electrolytes, trace elements, and vitamins to create an all-in-one pediatric parenteral nutrition bag, the stability of the final admixture depends on the composition, concentrations, pH, and container. Compounded pediatric parenteral nutrition bags are typically assigned an expiry of 24 to a maximum of 7 days, depending on whether they are stored at room temperature or refrigerated, and on local aseptic compounding standards. Light protection during prolonged infusion is particularly recommended for neonates to limit the formation of lipid hydroperoxides.
Before administration, the infusion bag and tubing should always be visually inspected. A normal Pedismof emulsion appears as a homogeneous, slightly yellow-white, milky fluid. Do not use if there is visible phase separation, oil droplets at the surface, discoloration, particulate matter, or damage to the container. These signs indicate destabilization or contamination, and the product must be discarded. Infusion of a cracked or contaminated emulsion can cause fat embolism and severe infection.
What Does Pedismof Contain?
Understanding the full composition of Pedismof is important for clinical decision-making, particularly regarding allergy assessment, caloric calculations, and compatibility with other components of pediatric parenteral nutrition regimens. The formulation is designed to provide a physiologically balanced fatty acid profile appropriate for the metabolic and developmental needs of children, with special attention to the vulnerabilities of preterm neonates.
Active Ingredients (Lipid Fraction)
The lipid fraction of Pedismof provides a total of 200 mg of lipids per mL (20% w/v) through four carefully chosen oils:
- Refined soybean oil (approximately 30% of total lipids): Supplies the essential fatty acids linoleic acid (omega-6) and alpha-linolenic acid (omega-3). These cannot be synthesized by the body and must be provided through nutrition.
- Medium-chain triglycerides (approximately 30% of total lipids): Derived from refined coconut or palm kernel oil. Because of their shorter chain length, MCT are oxidized rapidly in mitochondria without carnitine, providing immediately available energy.
- Refined olive oil (approximately 25% of total lipids): Supplies predominantly monounsaturated oleic acid. Olive oil reduces the omega-6 fatty acid load of the emulsion and contributes natural antioxidants (tocopherols).
- Fish oil rich in omega-3 fatty acids (approximately 15% of total lipids): Supplies long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are critical for brain and retinal development and modulate inflammatory eicosanoid pathways.
Excipients (Inactive Ingredients)
- Egg yolk phospholipids: Serve as the emulsifying agent, forming a phospholipid monolayer around each oil droplet to stabilize the oil-in-water emulsion. This is the reason Pedismof is contraindicated in egg-allergic children.
- Glycerol: Added to adjust the osmolality of the emulsion to near-physiological values, reducing the risk of venous irritation.
- Sodium oleate: Helps stabilize the emulsion by contributing to the negative surface charge of the lipid droplets.
- Alpha-tocopherol (vitamin E): Natural antioxidant that protects polyunsaturated fatty acids, particularly EPA and DHA from the fish oil fraction, from oxidative degradation.
- Sodium hydroxide: Used in small quantities to adjust the pH to approximately 7-8, matching the physiological range.
- Water for injections: The aqueous continuous phase of the emulsion, making up the majority of the volume.
Nutritional and Physicochemical Characteristics
| Parameter | Pedismof 20% (200 mg/mL) |
|---|---|
| Soybean oil | Approx. 60 mg/mL (6 g/100 mL) |
| Medium-chain triglycerides (MCT) | Approx. 60 mg/mL (6 g/100 mL) |
| Olive oil | Approx. 50 mg/mL (5 g/100 mL) |
| Fish oil (omega-3 rich) | Approx. 30 mg/mL (3 g/100 mL) |
| Egg phospholipids | Approx. 12 mg/mL |
| Glycerol | Approx. 25 mg/mL |
| Alpha-tocopherol | Approx. 150-300 micromol/L |
| Energy content | Approx. 2.0 kcal/mL (8.4 kJ/mL) |
| Osmolality | Approx. 380 mOsm/kg |
| pH | Approx. 7.5-8.5 |
| Fatty acid profile | Balanced mix of omega-6, omega-3, medium-chain, and monounsaturated fatty acids |
The specific proportions of oils in Pedismof, and in particular the ratio of omega-6 to omega-3 fatty acids (typically around 2.5:1), have been chosen to approximate the composition of human breast milk more closely than traditional pure soybean oil emulsions, whose omega-6 to omega-3 ratio is approximately 7:1. This balanced profile supports anti-inflammatory metabolic pathways, reduces the formation of pro-inflammatory omega-6-derived eicosanoids, and delivers preformed DHA for neurological development at a time when endogenous conversion of alpha-linolenic acid to DHA is limited in premature infants.
Frequently Asked Questions About Pedismof
Pedismof is an intravenous lipid emulsion used as part of parenteral nutrition for newborn infants, children, and adolescents who cannot be fed adequately by mouth or feeding tube. It supplies energy, essential fatty acids, and long-chain omega-3 fatty acids such as EPA and DHA, supporting growth, brain development, and immune function during a period when oral or enteral nutrition is not possible or sufficient.
Pedismof combines four oils - soybean oil, medium-chain triglycerides, olive oil, and fish oil - to provide a more balanced fatty acid profile than pure soybean oil emulsions. It contains less omega-6, more monounsaturated fat from olive oil, rapidly-oxidized MCT, and preformed omega-3 fatty acids (EPA and DHA) from fish oil. Clinical studies suggest that this composition reduces the risk of parenteral nutrition-associated liver disease and supports optimal brain and retinal development in growing children.
Yes. Pedismof is licensed for use in newborn infants including premature neonates. Modern guidelines recommend early initiation of intravenous lipids within the first 24 hours of life in preterm infants to prevent essential fatty acid deficiency and support growth. Starting doses are conservative (0.5-1 g/kg/day) and increased stepwise based on tolerance, serum triglycerides, bilirubin levels, and the overall clinical condition. Neonatal intensive care teams adapt the dose individually.
The most frequently observed side effects are transient increases in serum triglycerides and liver enzymes, nausea or vomiting, and a mild rise in body temperature during infusion. Uncommon effects include thrombophlebitis at peripheral infusion sites, tachycardia, and shortness of breath. Rare but serious reactions include fat overload syndrome, anaphylaxis in children allergic to fish, egg, soy, or peanut, and parenteral nutrition-associated liver disease during prolonged use. Any sign of allergic reaction or fat overload requires immediate discontinuation and medical review.
The medical team monitors serum triglycerides before starting Pedismof and at regular intervals thereafter. Thresholds to slow or pause the infusion are typically triglyceride levels above 3 mmol/L in neonates or above 4.5 mmol/L in older children. Liver function tests (ALT, AST, GGT, bilirubin), blood glucose, electrolytes, acid-base status, complete blood count with platelets, and coagulation parameters are also monitored. In infants and children, growth (weight, length, head circumference) and clinical response are followed throughout therapy.
Pedismof contains soybean oil, fish oil, and egg yolk phospholipids. It should not be used in children with known or suspected allergy to fish, egg, soybean, or peanut (because of cross-reactivity with soy). In such children, allergy evaluation by a specialist is recommended before considering alternative lipid emulsions based on different oil sources. All children receiving Pedismof should be observed carefully at the start of the first infusion for signs of an allergic reaction.
Parenteral nutrition-associated liver disease (PNALD) is a major complication of long-term intravenous nutrition in children, especially those with short bowel syndrome. The fish oil content of Pedismof appears to reduce the risk and severity of PNALD compared with pure soybean oil emulsions. Evidence from pediatric intestinal failure programs suggests that switching from a soybean oil-only emulsion to a fish-oil-containing or fish-oil-only emulsion can improve or even reverse cholestasis in some patients. Such treatment is directed by specialist pediatric gastroenterology and nutrition teams.
References
- Lapillonne A, Mis NF, Goulet O, et al. ESPGHAN/ESPEN/ESPR/CSPEN Guidelines on Pediatric Parenteral Nutrition: Lipids. Clinical Nutrition. 2018;37(6 Pt B):2324-2336.
- Joosten K, Embleton N, Yan W, et al. ESPGHAN/ESPEN/ESPR/CSPEN Guidelines on Pediatric Parenteral Nutrition: Energy. Clinical Nutrition. 2018;37(6 Pt B):2309-2314.
- Calder PC, Waitzberg DL, Klek S, Martindale RG. Lipids in Parenteral Nutrition: Biological Aspects. Journal of Parenteral and Enteral Nutrition. 2020;44(Suppl 1):S21-S27.
- Mirtallo JM, Ayers P, Boullata J, et al. ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1 & 2. Nutrition in Clinical Practice. 2020;35(5):769-782; 36(1):29-38.
- Goulet O, Antebi H, Wolf C, et al. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. Journal of Parenteral and Enteral Nutrition. 2010;34(5):485-495.
- Gura KM, Lee S, Valim C, et al. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008;121(3):e678-e686.
- Fell GL, Nandivada P, Gura KM, Puder M. Intravenous Lipid Emulsions in Parenteral Nutrition. Advances in Nutrition. 2015;6(5):600-610.
- Hojsak I, Colomb V, Braegger C, et al. ESPGHAN Committee on Nutrition position paper: Intravenous lipid emulsions and risk of hepatotoxicity in infants and children. Journal of Pediatric Gastroenterology and Nutrition. 2016;62(5):776-792.
- European Medicines Agency (EMA). Product information and Summary of Product Characteristics for lipid emulsions for parenteral nutrition, Fresenius Kabi. Accessed 2026.
- U.S. Food and Drug Administration (FDA). Drug Safety Communication and approved labeling for intravenous lipid emulsion products. Accessed 2026.
- World Health Organization. WHO Model List of Essential Medicines for Children, 9th List. Geneva: WHO. 2023.
- British National Formulary for Children (BNFc). Lipid emulsions monograph. Pharmaceutical Press / BMJ Publishing Group. Updated 2025.
Medical Editorial Team
This article has been written and reviewed by qualified medical professionals with expertise in pediatric clinical nutrition, neonatology, clinical pharmacology, and critical care.
Medical Content
iMedic Medical Editorial Team - Specialists in Pediatric Clinical Nutrition and Pharmacology
Medical Review
iMedic Medical Review Board - Independent review following ESPGHAN, ESPEN, ESPR, and CSPEN guidelines
Evidence Framework
GRADE methodology - Level 1A evidence from systematic reviews and randomized controlled trials in pediatric populations
Last Reviewed
- Next review scheduled within 12 months
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