Omegaven vials 100ml, 10pcs

Composition

1 liter of the emulsion contains:

Pharmacological action

Long-chain omega-3 fatty acids are partially incorporated into plasma and tissue lipids. Docosahexaenoic acid is an important component of structural phospholipids of cell membranes, eicosapentaenoic acid is a precursor for the synthesis of eicosanoids: prostaglandins, thromboxanes, leukotrienes and other lipid mediators. Polyunsaturated fatty acids of the omega-3 family affect the biophysical characteristics of cell membranes by changing the composition of phospholipids and cholesterol content, which improves the fluidity of the membrane. The concomitant increase in the ability to deform blood cells may explain the improvement in the rheological properties of blood when consuming fish oil or introducing Omegaven. In addition, polyunsaturated fatty acids of the omega-3 family modify the function of membrane enzyme systems, receptors, and pulse transmission. Omega-3 fatty acids improve the treatment of pathological disorders in premature infants, as well as inflammatory bowel diseases, psoriasis, atopic dermatitis, sepsis, burns, postoperative conditions, and cancer. Omegaven has an immunomodulatory, anti-inflammatory effect: it restores the ratio of lipid mediators of inflammation (including prostaglandin, thromboxanes, leukotriene, cytokines).

The most important are the long-chain omega-3 fatty acids: eicosapentaenoic acid (C 20: 5ω-3) and docosahexaenoic acid (C 22: 6ω-3). The ability of the human body to synthesize eicosapentaenoic acid and docosahexaenoic acid is very low. Therefore, eicosapentaenoic acid and docosahexaenoic acid must be supplied from the outside naturally with food or intravenously. The glycerol contained in Omegaven is used for energy production or re-esterified together with free fatty acids in the liver to form triglycerides. Egg yolk phospholipids are incorporated into cell membranes, being essential components for maintaining their integrity, or are hydrolyzed.

Pharmacokinetics:  The size of lipid globules administered with Omegaven and their biological properties are identical to those of physiological chylomicrons in the blood. In healthy male volunteers, the half-life of triglycerides administered intravenously with Omegaven was 54 minutes. The therapeutic effect of intravenous use of omega-3 fatty acids is characterized by a rapid onset of action and high efficiency in acute diseases.

Indications

• In the complex therapy of inflammatory bowel diseases, sepsis, burns, cachexia (in cancer, cardiological diseases, etc. ), and in postoperative conditions with a lack of omega-3 fatty acids.
• parenteral nutrition for adults with the inclusion of omega-3 fatty acids, especially eicosapentaenoic and docosahexaenoic, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Use during pregnancy and lactation

Omegaven should not be used during pregnancy and lactation, as there is insufficient evidence to support its safety in these conditions.

Contraindications

• Severe hemorrhagic disorders
• Certain acute and life-threatening conditions, such as: collapse and shock, acute stage of myocardial infarction, stroke, embolism, coma of unknown origin
• Omegaven should not be used in patients who are allergic to fish or egg whites.
• Children’s age

General contraindications for parenteral nutrition:  hypokalemia, hyperhydration, hypotonic dehydration, acidosis.

With caution, intravenous use of Omegaven may cause prolongation of bleeding time and inhibition of platelet aggregation. Therefore, Omegaven should be administered with caution in patients requiring anticoagulant therapy, even taking into account the possible reduction in the dose of these drugs. Omegaven should be administered with caution in patients with impaired lipid metabolism and uncontrolled diabetes mellitus. Due to lack of experience, Omegaven should not be prescribed in patients with severe hepatic or severe renal insufficiency.

Side effects

• Intravenous use of Omegaven can lead to prolonged bleeding time and inhibition (slowing down) of platelet aggregation.
• In rare cases, patients may experience a fishy taste in their mouth.

Side effects observed with the infusion of any fat emulsions:  Slight increase in body temperature, feeling hot and / or cold, chills, hyperemia or cyanosis, anorexia, nausea, vomiting, shortness of breath, headache; chest, back, lower back pain, ossalgia; priapism (in very rare cases), increased or decreased blood pressure, anaphylactic reactions (for example, erythema). Possible signs of metabolic overload should be monitored. The cause may be genetic (individual characteristics and metabolic disorders) or lipid metabolism may be affected by various previous diseases characterized by a varying rate of lipid metabolism, but this condition is observed mainly when using emulsions based on cottonseed oil. Metabolic overload can be manifested by the following symptoms: hepatomegaly with or without jaundice, changes or decreases in certain blood clotting parameters (for example, bleeding time, clotting time, prothrombin time, platelet count), splenomegaly, anemia, leukopenia, thrombocytopenia, bleeding or a tendency to bleeding, changes in liver function tests, fever, hyperlipidemia, headache, stomach pain, fatigue, hyperglycemia. As soon as these side effects occur or the triglyceride level during the infusion exceeds 3 mmol / l, the use of any fat emulsion should be stopped or, if necessary, continued at a lower rate of use of the drug.

Interaction

Intravenous use of Omegaven may prolong bleeding time and inhibit platelet aggregation. Therefore, Omegaven should be administered with caution in patients requiring anticoagulant therapy, even taking into account the possible reduction in the dose of these drugs. Omegaven can only be mixed with preparations of fat-soluble vitamins (Vitalipid) and water-soluble vitamins (Soluvit) and other fat emulsions (Intralipid, Lipovenoz, etc. ). Incompatibility:  Incompatibilities may occur with the addition of polyvalent cations (such as calcium), especially in combination with heparin.

How to take it, course of use and dosage

For central or peripheral vein infusion. The bottle should be shaken before use. When Omegaven is administered/used with other infusion media (e. g. amino acid solutions, carbohydrates) through a conventional intravenous infusion system, compatibility of the solutions and emulsions used must be guaranteed. Daily dose: 1-2 ml of Omegaven per 1 kg of body weight per day = 0.1-0.2 g of fish oil per 1 kg of body weight. This is approximately equal to 70-140 ml of Omegaven for a patient weighing 70 kg. Maximum daily dose: 2 ml / kg / day Maximum infusion rate: The infusion rate should not exceed 0.5 ml / kg / hour, which corresponds to 0.05 g of fish oil per 1 kg of body weight per hour. It is necessary not to exceed the maximum infusion rate, otherwise there may be a significant increase in the concentration of triglycerides in the blood serum. Omegaven can be administered simultaneously with other fat emulsions. Based on the recommended total daily fat intake of 1-2 g / kg of body weight, the proportion of fish oil administered with Omegaven should be 10-20% of this intake.

Special instructions

Daily monitoring of serum triglyceride concentrations is recommended. The serum triglyceride content during infusion of the fat emulsion should not exceed 3 mmol / l. Blood glucose, acid-base status, water-electrolyte balance, blood count, and bleeding time should be monitored regularly in patients receiving anticoagulant treatment.

Storage conditions

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

Shelf

life is 1.5 years. Do not use after the expiration date.

Active ingredient

Fat emulsions for parenteral nutrition

Conditions of release from pharmacies

By prescription

Dosage form

emulsion for infusions