Smoflipid 20% emulsion for infusions in a bottle of 100 ml No. 10

SMOFlipid 20% is a source of energy, essential fatty acids and omega-3 fatty acids for patients on a partial parenteral nutrition regimen when oral or enteral nutrition is impossible, insufficient or contraindicated.

Composition

Active ingredient: 1000 ml of solution contain 60 g of refined soybean oil, 60 g of medium chain triglycerides, 50 g of refined olive oil, 30 g of purified fish oil.

Excipients: egg yolk phospholipids, glycerol, DL-α-tocopherol, sodium oleate, sodium hydroxide (for pH adjustment), water for injections.

Contraindication

Hypersensitivity to fish, egg, soy proteins, peanuts or to any of the active or excipients; severe hyperlipidemia; severe hepatic insufficiency; severe blood clotting disorders; severe renal insufficiency without hemofiltration or dialysis; acute shock; general contraindications to infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure; unstable condition (e.g. after severe trauma, decompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).

Method of application

The standard dose is 1 - 2 g fat/kg body weight per day, corresponding to 5 - 10 ml/kg body weight per day. The recommended infusion rate is 0.125 g fat/kg body weight/h, corresponding to 0.63 ml SMOFlipid 20%/kg body weight/h and should not exceed 0.15 g fat/kg body weight/h, corresponding to 0.75 ml SMOFlipid 20%/kg body weight/h.

Features

Pregnant women

There is no data on the effects of SMOFlipid 20% during pregnancy and lactation.

Children

Used in pediatric practice.

Drivers

Data is missing.

Overdose

Overdose may cause fat overload syndrome if the infusion is too rapid or if the infusion is prolonged at the recommended rate due to changes in the patient's clinical condition, such as the development of renal failure or infection.

Overdose may lead to side effects. In these cases, lipid infusion should be discontinued or, if necessary, continued at a reduced dose.

Side effects

Respiratory system

Rare: shortness of breath.

From the digestive system

Uncommon: loss of appetite, nausea, vomiting.

From the vascular system

Rare: hypotension, hypertension.

General adverse reactions and injection site reactions

Common: slight increase in body temperature.

Uncommon: chills.

Rare: hypersensitivity reactions (anaphylactic or anaphylactoid reactions, skin rash, urticaria, flushing, headache), feeling hot or cold, pallor, cyanosis, pain in the neck, back, bones, chest and lower back.

From the reproductive system

Very rare: priapism.

Interaction

The use of heparin in clinical doses causes a transient increase in circulating lipoproteins. This may initially lead to a transient increase in plasma lipolysis and then to a decrease in triglyceride levels.

Soybean oil contains natural vitamin K1. However, its content in the preparation is very low, so it does not significantly affect the coagulation process in patients who were administered coumarin derivatives.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C. Do not freeze.

Shelf life after first opening the vial is no more than 24 hours at a temperature of 2 - 8°C.

Shelf life: 2 years.