Smoflipid 20% Injection

Adult administration

The standard dosage is 1.0–2.0 g/kg/day of fat (approximately 5–10 ml/kg/day). The recommended infusion rate is 0.125 g/kg/hr (approximately 0.63 ml/kg/hr) and should not exceed 0.15 g/kg/hr (approximately 0.75 ml/kg/hr). It should be administered as an infusion into a central vein or peripheral vein.

Child administration

- Neonates and infants: The initial dosage of fat is 0.5–1.0 g/kg/day, which can gradually be increased, with the fat intake reaching 3.0 g/kg/day (approximately 15 ml/kg/day) after several increments.

Care should be taken when administering this medicine to premature infants and low-birth-weight infants, as it may elevate free fatty acid levels in the blood. This medicine should not be used in patients allergic to fish, eggs, soybeans, peanut proteins, or any components of this product, in patients with severe hyperlipidemia or extremely poor liver function, in patients with severe bleeding disorders, in patients with extremely poor kidney function, or in patients in acute shock. Care should be taken when administering this medicine to patients who are likely to develop lipid metabolism disorders, such as those with diabetes, renal failure, pancreatitis, liver dysfunction, hypothyroidism, or sepsis. During administration of this medicine, adverse reactions such as blood pressure changes, shortness of breath, loss of appetite, nausea, vomiting, fever, skin rash, and urticaria may occur; any unusual symptoms should be immediately reported to a healthcare provider. Blood triglyceride levels should be regularly monitored to ensure they do not exceed 3 mmol/L, and if elevated, the dosage may need to be reduced or discontinued. This medicine should be prepared under sterile conditions, used immediately after opening, and any unused portion should not be stored for more than 24 hours at 2-8 degrees Celsius. The safety in pregnant or nursing women has not been established, so it should be used cautiously only when necessary. When mixing this medicine with other medications, the mixture should be used immediately, and visual inspection should ensure there is no phase separation in the mixture. During use, regular clinical tests such as blood glucose, liver function, and electrolytes should be performed to detect side effects early. If anaphylactic symptoms such as fever, tremors, skin rashes, or shortness of breath occur during treatment, administration should be stopped immediately, and appropriate treatment should be received. For storage, keep below 25 degrees Celsius and avoid freezing; any opened product should not be reused. Particularly for neonates and infants under 2 years of age, care should be taken to avoid light exposure to the solution during storage and administration.

Serious side effects

• Shortness of breath → Respiratory issues
• Hypersensitivity (anaphylactic or anaphylactoid reactions), urticaria → Severe allergic reactions
• Jaundice (including hepatomegaly) → Liver issues (jaundice)
• Coma → Severe neurological symptoms.

Mild side effects

• Hypotension
• hypertension
• loss of appetite
• nausea
• vomiting
• priapism
• increased body temperature
• chills
• skin rash
• urticaria

This medicine should be stored in a sealed container to prevent contact with air, and the storage temperature should be maintained between 1 degree and 25 degrees Celsius. This will help maintain the effectiveness of the medicine.

Appearance

A milky, homogeneous emulsion contained in a colorless, transparent glass bottle with a rubber stopper suitable for infusion.

Package unit

50 ml/bottle x 10, 100 ml/bottle x 10, 250 ml/bottle x 10, 500 ml/bottle x 10