Pedismof Infant (Four-Oil Pediatric Lipid Emulsion)
Intravenous lipid emulsion for parenteral nutrition in preterm newborns, term infants, and children
Quick Facts About Pedismof Infant
Key Takeaways About Pedismof Infant
- Designed for the youngest patients: Pedismof Infant is a balanced lipid emulsion specifically formulated for preterm and term newborns, infants, and children who cannot meet their nutritional needs through enteral feeding
- Four oils, balanced fatty acid profile: Combines refined soybean oil (essential fatty acids), medium-chain triglycerides (rapid energy), refined olive oil (monounsaturated fatty acids and vitamin E), and refined fish oil (EPA and DHA)
- Supports brain and eye development: The fish-oil component supplies preformed DHA, the dominant omega-3 fatty acid in neural and retinal membranes, supporting cognitive and visual maturation in critical developmental windows
- Lower risk of cholestasis: Compared with pure soybean-oil emulsions, mixed fish-oil-containing emulsions are associated with a lower risk of intestinal failure-associated liver disease (IFALD) during long-term parenteral nutrition
- Hospital administration with strict monitoring: Pedismof Infant is given by trained neonatal and pediatric teams via continuous intravenous infusion with careful monitoring of triglycerides, liver function, platelets, and infection markers
What Is Pedismof Infant and What Is It Used For?
Pedismof Infant is a four-oil intravenous lipid emulsion used as part of complete parenteral (intravenous) nutrition in preterm newborns, term infants, and children when oral or tube feeding cannot meet their full nutritional requirements. It supplies non-protein energy, essential fatty acids, and long-chain omega-3 fatty acids critical for growth, brain, eye, and immune development.
Pedismof Infant belongs to the pharmacotherapeutic group of intravenous nutrition solutions, classified as a fat emulsion under the ATC code B05BA02. It is a sterile, white, homogeneous emulsion in which microscopic lipid droplets are dispersed in an aqueous phase using egg phospholipids as an emulsifier and glycerol to maintain isotonicity. Each preparation contains a carefully balanced mixture of four oils, providing both energy and the building blocks for cell membranes, hormones, and signalling molecules during the most rapid phase of human growth.
In healthy children and adults, fat is normally absorbed from the diet through the gastrointestinal tract. When the digestive system cannot be used because of immaturity, surgery, congenital malformations, severe disease, or intestinal failure, intravenous feeding becomes life-saving. Lipid emulsions such as Pedismof Infant supply approximately 9 kilocalories per gram of fat, making them the most energy-dense component of parenteral nutrition. Without lipid intake, children dependent on intravenous feeding rapidly develop deficiencies of essential fatty acids that the body cannot synthesise from carbohydrate or protein.
Pedismof Infant is specifically indicated as a source of energy and essential fatty acids in:
- Preterm newborns: Babies born before 37 weeks of gestation who often require parenteral nutrition while their immature gut matures and oral feeding is gradually established
- Term newborns and infants: Full-term babies with congenital intestinal anomalies, necrotising enterocolitis, severe respiratory distress, post-surgical recovery, or other conditions that prevent adequate enteral nutrition
- Children: Pediatric patients of all ages with intestinal failure, short bowel syndrome, severe pancreatitis, oncology treatment, multi-organ failure, or other conditions where oral or tube feeding is contraindicated, insufficient, or not tolerated
The four-oil composition of Pedismof Infant was developed in response to the limitations of earlier first-generation pure soybean-oil emulsions. Traditional soybean-oil-only emulsions provide essential omega-6 fatty acids but contain very little long-chain omega-3 fatty acids and high levels of phytosterols, plant compounds that may contribute to cholestatic liver injury during prolonged parenteral nutrition. By combining four oils, Pedismof Infant achieves a more balanced omega-6 to omega-3 ratio (approximately 2.5 to 1), reduces phytosterol load, supplies preformed long-chain n-3 polyunsaturated fatty acids (EPA and DHA), and adds vitamin E (alpha-tocopherol) from olive oil for antioxidant protection.
Pedismof Infant is part of complete parenteral nutrition. To prevent essential fatty acid deficiency in long-term intravenous feeding, lipid emulsions must be administered as an integral component of nutrition together with amino acids, glucose, electrolytes, vitamins and trace elements. The decision to use any specific lipid emulsion in a child should be made by a pediatric or neonatal nutrition team experienced in parenteral nutrition.
What Should You Know Before Pedismof Infant Is Given?
Pedismof Infant must not be given to children with severe disturbances of fat metabolism, severe hyperlipidaemia, severe coagulopathy, allergy to egg, soy, peanut, fish or any excipient, or in conditions of acute shock, uncontrolled metabolic acidosis, untreated severe sepsis, or acute thromboembolic events. Careful clinical and laboratory assessment is required before and during therapy.
Contraindications
Pedismof Infant must not be administered under any of the following conditions:
- Hypersensitivity: Known allergy or hypersensitivity to fish, egg, soybean, peanut protein or to any of the active substances or excipients (egg phospholipids, glycerol, sodium oleate, sodium hydroxide)
- Severe hyperlipidaemia: Severely elevated blood triglycerides or other major disturbances of fat metabolism that cannot be controlled, including familial dyslipidaemias
- Severe coagulopathy: Severe blood clotting disorders that increase the risk of bleeding complications
- Acute shock and circulatory collapse: Patients with cardiovascular instability requiring resuscitation
- Uncontrolled metabolic acidosis: Severe metabolic acidosis interferes with lipid metabolism and clearance
- Untreated severe sepsis or septic shock: In acute septic shock, lipid emulsions may need to be temporarily withheld until the patient is stabilised
- Acute thromboembolic events or fat embolism: Patients with active embolic disease should not receive lipid infusions
- General contraindications to parenteral nutrition: Including severe hyperhydration, decompensated heart failure, severe hypotonic dehydration, and other conditions where intravenous fluid load is contraindicated
Warnings and Precautions
Before Pedismof Infant is started, the medical team will carefully evaluate the child's clinical status, fluid balance, organ function, and laboratory values. The following situations require additional caution:
- Newborns and preterm infants: Have a limited capacity to metabolise lipids; serum triglycerides must be monitored regularly and the dose adjusted accordingly. Hyperbilirubinaemia and pulmonary hypertension may require dose reduction
- Hepatic impairment: Children with liver disease or cholestasis require frequent monitoring of liver enzymes and bilirubin; lipid dose may need to be reduced
- Renal impairment: Fluid balance and electrolytes (especially phosphate) must be carefully managed in children with reduced kidney function
- Severe blood disorders: Including coagulation disorders, anaemia, and bone-marrow disease; platelet count and coagulation should be monitored regularly
- Electrolyte disturbances and disorders of fluid balance: These should be corrected before starting parenteral nutrition
- Disorders of lipid metabolism: Including familial hypertriglyceridaemia and lipoprotein lipase deficiency
- Existing infections or sepsis: Lipid clearance may be impaired; close monitoring is required
Anaphylactic reactions, including life-threatening reactions, have been reported with intravenous lipid emulsions. Pedismof Infant contains egg, soybean, and fish-derived components that may trigger immediate hypersensitivity in sensitised individuals. The infusion must be stopped immediately at the first sign of allergic reaction (skin rash, urticaria, breathing difficulty, hypotension, tachycardia or unexplained fever). Resuscitation equipment and trained staff must be immediately available throughout the infusion.
The body's ability to clear infused lipids must be monitored throughout therapy. Serum triglyceride concentration should be checked at baseline and during stable infusion; the lipid dose must be reduced or the infusion temporarily stopped if triglycerides exceed accepted thresholds (commonly above 250 mg/dL or 2.83 mmol/L during continuous infusion in newborns). Persistent hypertriglyceridaemia indicates that the patient cannot adequately clear the administered lipid load and may be at risk of fat overload syndrome.
Pedismof Infant should be infused through a dedicated lumen of a central venous catheter wherever possible. Strict aseptic technique is essential, because lipid emulsions support the growth of micro-organisms and central venous catheters are an important route for blood-stream infections. The infusion line, filter, and bag should be changed every 24 hours, and the prescribed maximum hang time must not be exceeded.
Pregnancy, Breastfeeding and Adult Use
Pedismof Infant is intended specifically for use in infants and children. There is no relevant indication for its use in pregnant or breastfeeding women. For adult parenteral nutrition, different lipid emulsions formulated for adult metabolism and dosing requirements (such as standard four-oil emulsions for adults) are used; the choice of preparation, total dose, and infusion rate differ from the pediatric formulation. Pregnant patients with intestinal failure who require parenteral nutrition should be managed by an experienced clinical nutrition team using preparations approved for adult use.
Effect on Laboratory Tests
Lipid emulsions can interfere with several laboratory measurements due to lipaemic interference in plasma samples. Affected tests may include bilirubin, lactate dehydrogenase, hemoglobin, oxygen saturation by some methods, and certain coagulation parameters. Blood samples should ideally be drawn at least 5 to 6 hours after the lipid infusion has been stopped, or after a defined wash-out period as advised by the laboratory. The clinical team should always inform the laboratory that the patient is receiving lipid infusion so that results can be interpreted accurately.
Special Pediatric Populations
Extremely preterm infants (born before 28 weeks): Have very limited fat tolerance during the first days of life. Starting doses are typically 1 g/kg/day or lower, with cautious daily increases under close laboratory monitoring. Insufficient lipid intake within the first week of life is associated with growth failure and worse neurodevelopmental outcomes, so the goal is to start early but progress gradually.
Newborns with hyperbilirubinaemia: Free fatty acids generated during lipid metabolism may displace bilirubin from albumin binding sites, theoretically increasing the risk of bilirubin neurotoxicity. While the clinical relevance with modern emulsions and lower doses is limited, lipid dose may be reduced in newborns with severe hyperbilirubinaemia approaching exchange transfusion thresholds.
Newborns with persistent pulmonary hypertension: High-dose lipid infusion may transiently affect pulmonary vascular tone. Doses are usually reduced and the infusion rate slowed in this group; pulse oximetry and clinical signs should be monitored carefully.
How Does Pedismof Infant Interact with Other Drugs?
Pedismof Infant has clinically important interactions with heparin (which mobilises lipoprotein lipase), vitamin K antagonists (because soybean oil contains vitamin K1), and antiplatelet drugs (because EPA and DHA may prolong bleeding time). It must never be co-infused with ceftriaxone in newborns and should be infused through a dedicated line whenever possible.
Although lipid emulsions themselves have a relatively limited pharmacological interaction profile compared with conventional drugs, they can affect the disposition of several medicines and are subject to important physico-chemical incompatibilities. Inform the medical and pharmacy team about every drug, vitamin, herbal remedy, and intravenous infusion the child is receiving, so that potential interactions and incompatibilities can be assessed.
Major Interactions
| Interacting Substance | Type | Effect | Recommendation |
|---|---|---|---|
| Ceftriaxone (in newborns) | Major - physical incompatibility | Forms insoluble calcium-ceftriaxone precipitates that may cause fatal embolic events in lungs and kidneys | Must NEVER be co-infused with calcium-containing solutions (including Pedismof Infant) in newborns through the same or different lines |
| Heparin (therapeutic doses) | Major - pharmacodynamic | Releases lipoprotein lipase into the circulation, transiently increasing plasma free fatty acid concentrations and possibly impairing fat clearance | Use lowest effective heparin dose; monitor triglycerides; avoid bolus heparin during lipid infusion when possible |
| Vitamin K antagonists (warfarin) | Major - pharmacodynamic | Soybean oil contains vitamin K1 which can antagonise the anticoagulant effect | Monitor INR more frequently in children on coumarin anticoagulants and adjust the anticoagulant dose accordingly |
| Antiplatelet drugs / anticoagulants (high doses) | Major - pharmacodynamic | EPA and DHA from fish oil may prolong bleeding time at high doses, increasing the risk of bleeding | Monitor coagulation parameters and clinical signs of bleeding in children on antiplatelet or anticoagulant therapy |
Minor Interactions and Compatibility Considerations
| Interacting Substance | Type | Effect | Recommendation |
|---|---|---|---|
| Insulin (in PN bag) | Minor - physical | May adsorb to plastic infusion containers; bioavailability difficult to predict | If insulin needed, prefer separate infusion via syringe pump; do not add to lipid emulsion bag |
| Calcium and phosphate salts | Minor - physical | May form insoluble calcium phosphate precipitates depending on concentration, pH and temperature | Compounding by hospital pharmacy with verified compatibility ranges; use in-line filter; visual inspection before infusion |
| Fat-soluble vitamins (A, D, E, K) | Minor - additive | Pedismof Infant supplies vitamin K1 from soybean oil and vitamin E from olive oil; additional vitamin supplements may be added as part of complete parenteral nutrition | Total daily intake of fat-soluble vitamins should be calculated by the prescribing clinician to avoid over- or under-dosing |
| Other intravenous drugs | Variable - compatibility | Many intravenous drugs are incompatible with lipid emulsions and may cause emulsion cracking or drug precipitation | Do not add or co-infuse drugs into the Pedismof Infant line unless compatibility is documented; use a dedicated lumen whenever possible |
If a child is receiving multiple infusions, the prescribing team and pharmacy should map every drug to a specific lumen of the central venous catheter to avoid mixing incompatible solutions. When dedicated lines are not available, established Y-site compatibility data must be checked before each co-infusion. Visible separation of the emulsion (cracking), discoloration, or appearance of a yellow or oily layer indicates that the emulsion is no longer safe to use and must be discarded.
What Is the Correct Dosage of Pedismof Infant?
Lipid dosing in pediatric parenteral nutrition is individualised based on age, weight, clinical status and laboratory parameters. Typical starting doses are 1 to 2 g lipid per kg per day, increased stepwise to a maximum of 3 to 4 g/kg/day in newborns and 2 to 3 g/kg/day in older children. Maximum infusion rate is 0.15 g lipid/kg/hour and the daily dose is given as a continuous infusion over 24 hours.
Pedismof Infant is prescribed and administered exclusively by a healthcare professional with experience in pediatric or neonatal parenteral nutrition. The dose, infusion rate, and total duration of therapy are tailored individually to the child based on body weight, gestational age, clinical condition, fluid balance, and serial laboratory monitoring. Dosing recommendations are guided by the joint ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition), ESPEN (European Society for Clinical Nutrition and Metabolism), ESPR and CSPEN pediatric parenteral nutrition guidelines, and by the product's authorised prescribing information.
Preterm and Term Newborns
Standard Newborn Dosing
The lipid dose is typically introduced at 1 to 2 g/kg/day on the first day of parenteral nutrition and increased by approximately 1 g/kg/day to a maximum of 3 to 4 g/kg/day, depending on the clinical status, energy requirements and serum triglyceride tolerance. Lipid emulsions should provide approximately 25 to 50% of the non-protein energy intake. The infusion rate should not exceed 0.15 g lipid/kg/hour (corresponding to 0.75 ml/kg/hour of a 20% emulsion).
Infants and Children
Standard Pediatric Dosing
In infants beyond the neonatal period and older children, lipid dose typically ranges from 1 to 3 g/kg/day. The starting dose is usually 1 g/kg/day, advanced over 24 to 48 hours to the target dose. The maximum recommended dose for children is 3 g/kg/day; in adolescents and during long-term home parenteral nutrition, doses are often reduced to 1 to 2 g/kg/day to minimise the risk of hepatic complications. As in newborns, the maximum infusion rate is 0.15 g lipid/kg/hour and the lipid component should be infused continuously over 24 hours.
Administration Methods
| Setting | Route / Access | Typical Dose | Infusion | Notes |
|---|---|---|---|---|
| Neonatal intensive care | Umbilical venous catheter, PICC, or peripheral cannula | 1-3 g/kg/day, advanced stepwise from day 1 | Continuous over 24 hours via syringe or volumetric pump | Use light-protected syringe and tubing; check triglycerides daily during dose escalation |
| Pediatric ICU / surgery | Central venous catheter (preferred for prolonged use) | 1-3 g/kg/day depending on age and clinical status | Continuous over 24 hours; may use cycling in stable patients | In-line 1.2-micron filter; dedicated lumen recommended; daily inspection of access site |
| Home parenteral nutrition | Tunnelled central catheter or implanted port | Reduced lipid dose, often 1-2 g/kg/day | Cycled overnight infusion (12-16 hours) with infusion-free interval | Caregivers receive structured training; protocols for catheter care, alarm response, and emergencies |
| Compounded all-in-one bag | Central or peripheral access (osmolality dependent) | As component of total parenteral nutrition admixture | Continuous over 24 hours after pharmacy compounding | Compounded under aseptic conditions in hospital pharmacy with documented compatibility |
Adults
Pedismof Infant is intended for the pediatric population. Adult patients requiring intravenous lipid therapy as part of parenteral nutrition should receive an emulsion that has been authorised for adult use. The choice of preparation depends on the underlying disease, expected duration of therapy, organ function, and risk of hepatic complications, and should be guided by clinical nutrition protocols and the responsible specialist team.
Elderly
The pediatric formulation is not indicated for elderly patients. Older adults requiring parenteral nutrition should be assessed individually, with attention to cardiovascular tolerance of fluid and lipid loads, hepatic and renal function, and concurrent medications. Adult-specific lipid emulsions are used, and dose ranges for adults are lower per kilogram of body weight than for children.
Missed Dose
Because Pedismof Infant is administered as a continuous intravenous infusion in a hospital setting under medical supervision, missed doses in the conventional sense do not apply. If the infusion is interrupted (for example, due to line malfunction or an unrelated procedure), the medical team will reassess the daily nutritional plan, calculate the cumulative intake achieved, and decide whether the residual dose can be safely caught up over the remainder of the day or whether the next 24-hour cycle should simply be restarted. Caregivers managing home parenteral nutrition should follow the specific written instructions provided by the home nutrition team and contact them immediately if an infusion is delayed or interrupted.
Overdose
Acute lipid overdose may occur if the prescribed dose or infusion rate is exceeded, or if the patient cannot adequately metabolise the administered fat. Clinical features of fat overload syndrome include sudden hypertriglyceridaemia, fever, fat infiltration of organs, hepatomegaly with or without jaundice, splenomegaly, anaemia, leukopenia, thrombocytopenia, coagulation disorders, and central nervous system manifestations such as coma. Management consists of immediately stopping the lipid infusion, supportive care, and treatment of secondary complications. The fat overload is generally reversible once the infusion is discontinued, although recovery may take several days. Plasma exchange has been used in severe cases. Suspected overdose must always be reported to the responsible medical team without delay.
What Are the Side Effects of Pedismof Infant?
Most children tolerate Pedismof Infant well when it is prescribed and monitored according to current guidelines. The most clinically important risks are hypersensitivity reactions, hypertriglyceridaemia, fat overload syndrome, parenteral nutrition-associated liver disease, thrombocytopenia, and catheter-related complications. Frequencies of specific adverse drug reactions are taken from clinical trials and post-marketing experience with the four-oil pediatric lipid emulsion.
Stop the infusion immediately and seek urgent medical attention if a child develops difficulty breathing, sudden facial or throat swelling, generalised hives or skin rash, sudden drop in blood pressure, severe abdominal pain, profound vomiting, sudden chest pain or signs of circulatory collapse, or rapidly worsening jaundice. These may indicate a serious hypersensitivity reaction, fat overload, or another life-threatening complication.
Adverse reactions to intravenous lipid emulsions can be classified as acute (occurring during or shortly after the infusion) or chronic (developing over weeks to months of long-term parenteral nutrition). Acute effects include hypersensitivity, hypertriglyceridaemia, hyperthermia and gastrointestinal symptoms. Chronic complications include hepatobiliary dysfunction, growth or developmental concerns, and catheter-related infections, which are more closely linked to the underlying disease and the parenteral nutrition strategy as a whole than to a single component of the regimen.
Common Side Effects
- Transient elevation of serum triglycerides
- Mild rise in liver enzymes (ALT, AST, gamma-GT, alkaline phosphatase)
- Mild increase in conjugated bilirubin during prolonged use
- Hyperglycaemia (often related to overall PN regimen)
- Hypothermia or transient hyperthermia
Uncommon Side Effects
- Tachycardia or other heart rhythm changes
- Hypertension or hypotension
- Nausea, vomiting, abdominal distension
- Loss of appetite (in older children)
- Headache
- Local irritation, phlebitis or erythema at the infusion site
- Mild allergic skin reactions (rash, urticaria)
Rare Side Effects
- Severe hypersensitivity reactions, including anaphylaxis
- Cyanosis
- Significant hypertriglyceridaemia requiring dose interruption
- Cholestasis (intra-hepatic bile flow obstruction)
- Pancreatitis
- Thrombocytopenia and leukopenia during long-term use
- Fat embolism (extremely rare)
Very Rare / Long-Term Effects
- Intestinal failure-associated liver disease (IFALD) with cirrhosis
- Fat overload syndrome (hepatomegaly, splenomegaly, coagulopathy, anaemia)
- Persistent hyperbilirubinaemia in long-term home PN
- Lipid-related deposits in the reticuloendothelial system
- Hepatic steatosis in very long-term parenteral nutrition
Frequency Not Known
- Increased susceptibility to bacterial or fungal infections (mainly catheter-related rather than emulsion-specific)
- Disturbances in essential fatty acid balance with very low or interrupted dosing
- Reactions related to specific excipients in sensitised individuals
Infusion Site and Catheter-Related Reactions
Peripheral vein infusion: Lipid emulsions infused through small peripheral veins may cause local irritation, phlebitis, and venous thrombosis, particularly when combined with hyperosmolar parenteral nutrition admixtures. Whenever possible, parenteral nutrition is delivered through a central venous catheter, especially when the duration is expected to exceed a few days.
Central venous catheter complications: Catheter-related infections (line sepsis), catheter occlusion, catheter migration, and central venous thrombosis are well-recognised complications of long-term parenteral nutrition. Strict aseptic technique during line care, daily inspection of the access site, and structured catheter-care bundles substantially reduce the risk. Sudden fever, rigors, redness, swelling or purulent discharge at the catheter site requires immediate medical assessment.
Parenteral Nutrition-Associated Liver Disease
Children receiving parenteral nutrition for more than two weeks are at risk of developing parenteral nutrition-associated cholestasis, also referred to as intestinal failure-associated liver disease (IFALD). The risk increases with prolonged duration, prematurity, recurrent sepsis, lack of enteral intake, and certain lipid emulsions. Early markers include rising conjugated bilirubin, gamma-GT, and alkaline phosphatase. Strategies to mitigate IFALD include early enteral feeding when possible, careful infection prevention, avoidance of overfeeding, lipid dose reduction (often to 1 g/kg/day), and the use of fish-oil-containing or fish-oil-only emulsions in established cholestasis. The four-oil composition of Pedismof Infant has been associated with a lower risk of IFALD compared with pure soybean-oil emulsions.
Reporting Side Effects
Reporting suspected side effects after a medicine has been authorised is important for ongoing safety monitoring of pediatric medicines. Healthcare professionals, parents, and caregivers are encouraged to report any suspected adverse reactions to their national medicines regulatory authority (for example the EMA's EudraVigilance system in the European Union or the FDA MedWatch programme in the United States). Reports help authorities to continuously monitor the benefit-risk balance of intravenous lipid emulsions in vulnerable pediatric populations.
How Should Pedismof Infant Be Stored?
Pedismof Infant is stored at room temperature (below 25 degrees Celsius), protected from light, and must not be frozen. Bags or bottles should be inspected before use; only homogeneous, milky-white emulsions without visible separation, oil droplets or discoloration may be infused. Once opened or compounded, the emulsion is for single use only.
Storage conditions for Pedismof Infant are critical because lipid emulsions are physically delicate systems that can break down when exposed to extreme temperatures, light, or improper handling. The following storage requirements apply to unopened products as supplied by the manufacturer:
- Temperature: Store at room temperature, generally below 25 degrees Celsius. Do not refrigerate routinely unless specified by local pharmacy protocols, and never freeze. Frozen emulsions must be discarded
- Protection from light: Keep the product in its original outer carton until use; light exposure can promote lipid peroxidation, especially in the presence of vitamins A, C, and copper-containing trace element solutions
- Original packaging: Store in the manufacturer's original container; do not transfer to other containers
- Out of reach of children: Although Pedismof Infant is administered exclusively in clinical settings, all medicines should be stored where unsupervised children cannot access them
- Expiry date: Do not use Pedismof Infant after the expiry date printed on the label and outer carton; the expiry date refers to the last day of the indicated month
Inspection Before Use
Every bag or bottle of Pedismof Infant must be visually inspected immediately before administration. The emulsion should appear as a homogeneous, milky-white liquid without visible particles, oil droplets, layer separation, or discoloration. Indicators that the product must NOT be used include:
- Phase separation: Visible oil layer on the surface or yellow-brown discoloration
- Cracking: Loss of homogeneity, with visible droplets larger than the rest of the emulsion (a phenomenon called "creaming" that does not redisperse on gentle inversion)
- Damaged container: Cracks, leaks, or compromised primary packaging
- Frozen product: Even if subsequently thawed, the integrity of the emulsion cannot be guaranteed
Stability After Opening or Compounding
Once Pedismof Infant has been opened or used to compound an all-in-one parenteral nutrition admixture, the in-use stability is limited. Compounded admixtures should be infused within the time stated on the pharmacy label, typically not exceeding 24 hours at room temperature for the infusion itself. Refrigeration may extend pre-use storage of compounded admixtures (often 6 to 7 days at 2 to 8 degrees Celsius) provided that aseptic compounding has been documented and the formulation has demonstrated chemical and physical stability under these conditions. Any unused product, partially used containers, or visibly altered emulsion must be discarded according to local pharmaceutical waste regulations.
What Does Pedismof Infant Contain?
Each 100 ml of Pedismof Infant contains 20 g of triglycerides as a balanced blend of refined soybean oil, medium-chain triglycerides, refined olive oil, and refined fish oil, providing approximately 200 kcal and a defined supply of essential omega-6 and omega-3 fatty acids. Excipients include egg phospholipids, glycerol, sodium oleate, sodium hydroxide, and water for injections.
Active Ingredients (Composition)
Pedismof Infant is a 20% lipid emulsion. The active substances are four refined oils combined to provide a balanced fatty acid profile, energy density, and antioxidant content suitable for the youngest patients:
| Component | Amount per 100 ml | Function |
|---|---|---|
| Refined soybean oil | Approx. 6.0 g | Provides essential omega-6 (linoleic acid) and omega-3 (alpha-linolenic acid) fatty acids, and vitamin K1 |
| Medium-chain triglycerides (MCT) | Approx. 6.0 g | Rapid energy source that does not require carnitine for mitochondrial uptake; ketogenic and easily oxidised |
| Refined olive oil | Approx. 5.0 g | Source of monounsaturated oleic acid and natural alpha-tocopherol (vitamin E) for antioxidant protection |
| Refined fish oil | Approx. 3.0 g | Supplies long-chain omega-3 PUFAs EPA and DHA for brain, retinal, and immune development; precursors of resolvins and protectins |
| Total triglycerides | 20 g | Approximately 200 kcal (840 kJ) of non-protein energy per 100 ml |
Inactive Ingredients (Excipients)
- Egg phospholipids (purified): Acts as the emulsifier that stabilises the dispersed lipid droplets within the aqueous phase
- Glycerol: Adjusts the osmolality of the emulsion to make it isotonic and suitable for intravenous infusion
- Sodium oleate: Co-emulsifier that contributes to droplet surface charge and emulsion stability
- Sodium hydroxide: Used in small quantities to adjust the pH of the emulsion
- Water for injections: The aqueous vehicle of the emulsion
Pedismof Infant typically also provides small endogenous quantities of vitamin E (alpha-tocopherol) and vitamin K1 originating from the natural oils. The total caloric content of the emulsion is approximately 2.0 kcal per ml (8.4 kJ per ml), which makes it the most energy-dense component of pediatric parenteral nutrition.
Available Pack Sizes
| Container Size | Lipid Content | Approx. Energy | Typical Use |
|---|---|---|---|
| 50 ml glass bottle / bag | 10 g lipid | ~100 kcal | Very low birth-weight neonates; small dose increments |
| 100 ml glass bottle / bag | 20 g lipid | ~200 kcal | Neonatal and infant parenteral nutrition |
| 250 ml glass bottle / bag | 50 g lipid | ~500 kcal | Older infants and children; pediatric ICU |
Pedismof Infant is supplied as a sterile, pyrogen-free, milky-white emulsion in primary containers designed for parenteral use. Not all pack sizes may be marketed in every country. The product is manufactured by Fresenius Kabi at facilities certified to international Good Manufacturing Practice (GMP) standards.
Availability and Authorisation
Four-oil pediatric lipid emulsions of this type are authorised across many regulatory regions, including the European Union (via national authorisations and EMA-coordinated procedures), the United Kingdom (MHRA), and various other markets worldwide. The exact trade name, pack size and licensed indication may vary between countries. The closely related adult and pediatric formulations of the same four-oil concept are sometimes marketed under names such as SMOFlipid (adults) and SMOFlipid 20% / pediatric variants. Healthcare teams must always use the locally approved formulation according to its national prescribing information.
Frequently Asked Questions About Pedismof Infant
Medical References
- European Medicines Agency (EMA). "Summary of Product Characteristics for SMOFlipid and pediatric four-oil lipid emulsions." European regulatory product information for four-oil lipid emulsions used in pediatric parenteral nutrition.
- Mihatsch WA, Braegger C, Bronsky J, et al. ESPGHAN/ESPEN/ESPR/CSPEN working group on pediatric parenteral nutrition (2018). "ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition." Clinical Nutrition. 37(6 Pt B):2303-2305. https://doi.org/10.1016/j.clnu.2018.05.029 International evidence-based pediatric parenteral nutrition guidelines, including dosing of intravenous lipid emulsions in newborns and children.
- Lapillonne A, Fidler Mis N, Goulet O, et al. (2018). "ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Lipids." Clinical Nutrition. 37(6 Pt B):2324-2336. https://doi.org/10.1016/j.clnu.2018.06.946 Lipid-specific guideline section detailing the choice of emulsion, dosing, infusion rate, and monitoring in pediatric parenteral nutrition.
- Goulet O, Antebi H, Wolf C, et al. (2010). "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." JPEN Journal of Parenteral and Enteral Nutrition. 34(5):485-495. https://doi.org/10.1177/0148607110363614 Pivotal randomized trial of a four-oil lipid emulsion (the same composition as Pedismof Infant) in children on home parenteral nutrition.
- U.S. Food and Drug Administration (FDA). "SMOFlipid prescribing information." FDA Drug Approval Database FDA-approved prescribing information for the four-oil lipid emulsion used in pediatric and adult parenteral nutrition.
- Hojsak I, Colomb V, Braegger C, et al. (2016). "ESPGHAN Committee on Nutrition Position Paper. Intravenous Lipid Emulsions and Risk of Hepatotoxicity in Infants and Children: a Systematic Review and Meta-analysis." Journal of Pediatric Gastroenterology and Nutrition. 62(5):776-792. https://doi.org/10.1097/MPG.0000000000001121 Systematic review evaluating the risk of intestinal failure-associated liver disease with different intravenous lipid emulsions in infants and children.
- Lapillonne A, Eleni dit Trolli S, Kermorvant-Duchemin E (2010). "Postnatal docosahexaenoic acid deficiency is an inevitable consequence of current recommendations and practice in preterm infants." Neonatology. 98(4):397-403. https://doi.org/10.1159/000320159 Demonstrates the importance of preformed DHA delivery in preterm infants and the role of fish-oil-containing lipid emulsions.
- National Institute for Health and Care Excellence (NICE). "Neonatal parenteral nutrition. NICE guideline [NG154]." NICE Guidance NG154 UK national guideline on neonatal parenteral nutrition, including recommendations on lipid emulsion choice and monitoring.
- World Health Organization (WHO) (2023). "Model List of Essential Medicines for Children - 9th List." WHO Essential Medicines for Children WHO list of essential medicines for children including parenteral nutrition components.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
iMedic Editorial Standards
Peer Review Process
All medical content is reviewed by at least two licensed specialist physicians before publication.
Fact-Checking
All medical claims are verified against peer-reviewed sources and international guidelines.
Update Frequency
Content is reviewed and updated at least every 12 months or when new research emerges.
Corrections Policy
Any errors are corrected immediately with transparent changelog.
Medical Editorial Board: iMedic has an independent medical editorial board consisting of specialist physicians in neonatology, pediatrics, clinical nutrition, and clinical pharmacology.