SMOFlipid (soybean oil refined) 20% emulsion for infusions 100 ml. vial №1

Description

SMOFlipid (soybean oil refined) 20% emulsion for infusions 100 ml. vial №1

Composition

active substances:

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 refined fish oil.

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

Dosage form

Emulsion for infusions.

Main physical and chemical properties: homogeneous white emulsion.

Pharmacotherapeutic group

Solutions for parenteral nutrition. Fat emulsions.
ATX code B05B A02.

Pharmacological properties

The particles of the fat emulsion have a size and biological properties similar to endogenous chylomicrons. Components of SMOFlipid soybean oil, medium chain triglycerides, olive oil and omega-6 fatty acids, due to its pharmacodynamic properties are an energy source. SMOFlipid 20% is a source of energy. Soybean oil has a high content of essential fatty acids. Omega-6 fatty acids and linoleic acid account for the largest share (55-60%). Alpha-linolenic acid and omega-3 fatty acids make up almost 8%. This part of SMOFlipid 20% provides the required amount of essential fatty acids, which are rapidly oxidized and provide the body with energy. Olive oil provides mainly energy in the form of monounsaturated fatty acids, which are less prone to peroxidation than the corresponding amount of polyunsaturated fatty acids. Fish oil is characterized by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, while EPA is a precursor of eicosanoids: prostaglandins, thromboxanes and leukotrienes.

Vitamin E protects unsaturated fatty acids from lipid peroxidation.

Indication

SMOFlipid is a 20% 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 not possible, insufficient or contraindicated.

Contraindication

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

Use during pregnancy or breastfeeding

There are no data on the effect of SMOFlipid 20% during pregnancy and lactation. There are no reproductive toxicity studies. SMOFlipid 20% should be used by pregnant and breastfeeding women after careful examination. The drug should be prescribed only when the expected beneficial effect for the mother outweighs the potential risk to the fetus.

Method of application and dosage

Intravenous infusions into the central or peripheral veins.

When used in newborns and children under 2 years of age, the solution (in vials and kits for administration) should be protected from light until completion of administration.

• Adults
  The standard dose is 1 – 2 g fat / kg body weight per day, which corresponds 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 of SMOFlipid 20% / kg body weight / hour
• Newborns and babies
  The initial dose should be 0.5 – 1 g fat / kg body weight per day, followed by a successive increase of 0.5 – 1 g fat / kg body weight per day. It is recommended not to exceed the daily dose – 3 g of fat / kg of body weight per day, which corresponds to 15 ml of SMOFlipid 20% / kg of body weight per day. The infusion rate should not exceed 0.125 g fat / kg body weight / hour.
  Premature and newborn infants with low body weight SMOFlipid 20% should be administered continuously for 24 hours.
• Children
  It is recommended not to exceed a daily dose of 3 g fat / kg body weight / day, which corresponds to 15 ml of SMOFlipid 20% / kg body weight per day. The daily dose should be increased gradually during the first week. The infusion rate should not exceed 0.15 g fat / kg body weight / hour.

Children

Used in pediatric practice.

Overdose

Overdose may cause fat overload syndrome if the infusion is too rapid or the infusion is prolonged at the recommended rate due to changes in the patient’s clinical condition, such as renal failure or infection.
Overdose can lead to side effects. In these cases, lipid infusions should be stopped or, if necessary, continued by reducing the dose.

Side effects:

• From the respiratory system: shortness of breath.
• From the digestive system: loss of appetite, nausea, vomiting.
• From the vascular system: hypotension, hypertension.
• General adverse reactions and reactions at the injection site: slight fever, chills, hypersensitivity reactions (anaphylactic or anaphylactoid reactions, skin rash, urticaria, redness, headache), feeling hot or cold, paleness, cyanosis, neck, back pain, bones, chest and lower back.
• From the reproductive system: priapism.

In case of adverse reactions, the infusion of SMOFlipid 20% should be stopped or continued by reducing the dose.
If the level of triglycerides during the infusion rises above 3 mmol / l, the administration of SMOFlipid 20% should be stopped or, if necessary, continued by reducing the dose.