OMEGAVEN

Active material: highly purified fish oil, Tocopherol
When ATH: B05BA02
CCF: The preparation for parenteral nutrition – fatliquor
ICD-10 codes (testimony): E63.0, R63.3
When CSF: 21.08.03
Manufacturer: FRESENIUS KABI GERMANY GmbH (Germany)

Pharmaceutical form, composition and packaging

Emulsion for infusion white or white with a cream shade, Homogeneous.

Excipients: glycerol, Sodium hydroxide (to maintain pH), sodium oleate, water d / and.

50 ml – bottles (10) – packs cardboard.

Pharmacological action

The preparation for parenteral use, in which the composition contains long chain omega-3-fatty acids, which are partially included in the plasma and tissue lipids. DHA is an important structural component of the phospholipids of cell membranes, eicosapentaenoic acid – the precursor for the synthesis of eicosanoids: prostaglandins, thromboxanes, leukotrienes and other lipid mediators.

Polyunsaturated fatty acids are omega-3 family affect the biophysical characteristics of cell membranes by altering the composition of phospholipids and cholesterol, which improves membrane fluidity. The concomitant increase in the capacity for deformation of blood cells may be an explanation for improving the rheological properties of blood in the consumption of fish oil or introduction Omegaven. Besides, polyunsaturated fatty acids omega-3 family modify the function of membrane enzyme systems, receptors, as well as the transmission of impulses.

Omega-3 fatty acids, included in the combination therapy, improve for inflammatory bowel disease, psoriasis, atopic dermatitis, Sepsis, burns, post surgery, oncological diseases.

Omegaven has immunomodeliruyuschy effect: restores ratio lipid inflammatory mediators (divided into prostaglandins, thromboxanes, leukotrienes, Cytokine).

Most important are the long chain fatty acids omega-3 family: eicosapentaenoic acid (C20:5omega-3) and docosahexaenoic acid (C22:6omega-3). The ability of the human body to synthesise EPA and DHA is very low. Hence, eicosapentaenoic acid and docosahexaenoic acid have come from outside in a natural way with food or /.

Glycerol, contained in Omegavene, used for energy production or reesterifitsiruetsya together with the free fatty acids in the liver to form triglycerides.

Phospholipids of egg yolk incorporated into cell membranes, It is essential components to maintain their integrity, or hydrolyze.

The therapeutic effect with a / in the way the introduction of a family of fatty acids omega-3 is characterized by rapid onset of action and high efficiency in acute diseases.

Pharmacokinetics

Size lipidnыh globul, entered from Omegavenom, and biological properties identical to those of physiological chylomicrons in the blood.

In healthy volunteers (Men) the half-life of triglycerides, input / in up to Omegavenom 54 m.

Testimony

- Prevention and treatment of deficiency of omega-3 fatty acids in the treatment of inflammatory bowel disease, Sepsis, burns, kaxeksii (oncological, heart disease), postoperatively, under conditions, When enteral limited;

- The parenteral nutrition of adults with the inclusion of omega-3-fatty acids, especially eicosapentaenoic and docosahexaenoic, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosage regimen

The average daily dose is Omegaven 1-2 ml / kg body weight, corresponding 100-200 mg fish oil / kg body weight. For a patient weighing 70 kg it is about 70-140 ml Omegaven. The maximum daily dose – 2 ml / kg body weight.

The drug is administered by infusion into a central or peripheral vein. The infusion rate should not exceed 0.5 ml / kg / h, corresponding 50 mg fish oil / kg body weight / h. It should not exceed the maximum rate of infusion, otherwise there may be a significant increase in the concentration of triglycerides in blood serum. The vial should be shaken before use.

When Omegaven introduced with other infusion solutions (eg, solutions of amino acids, carbohydrates) through the usual system for / in infusions, It must be guaranteed compatibility, the solutions and emulsions.

Side effect

From the blood coagulation system: prolonged bleeding, and depression (slowdown) platelet aggregation.

Other: rarely – fishy taste in the mouth.

Side effects, observed during the infusion of any fatliquors: slight fever, sensation of heat and / or cold, chills, redness or cyanosis, anorexia, nausea, vomiting, breathlessness, headache, chest pain, back, loin, ossalgia, increased or decreased blood pressure, anaphylactic reactions (eg, эritema); in a few cases – priapism.

Contraindications

- Severe haemorrhagic disorders;

- Acute life-threatening condition, such as collapse and shock, acute phase of myocardial infarction, stroke, embolism, coma of unknown origin;

- An allergic reaction to fish or egg protein;

- Children's age;

General contraindications for parenteral nutrition

- Hypokalemia;

- Gipergidratatsiya;

- Hypotonic dehydration;

- Acidosis.

FROM caution should be prescribed to patients, simultaneously receiving anticoagulant therapy, in violation of lipid metabolism, uncontrolled diabetes, Patients with severe hepatic or severe renal insufficiency.

Pregnancy and lactation

Omegaven should not be used during pregnancy and lactation, because insufficient data, confirming its safety in these conditions.

Cautions

The application period is recommended Omegaven daily monitoring of serum triglyceride concentrations. Triglycerides in serum during infusion of a fat emulsion should not exceed 3 mmol / l.

It should regularly monitor blood glucose levels, acid-base state, water-balance élektrolitnyj, formula peripheral blood and bleeding time in patients, receiving treatment with anticoagulants.

Introduction Omegaven can cause prolonged bleeding and platelet aggregation. Therefore Omegaven should be used with caution in patients, receiving treatment with anticoagulants, and, if necessary, should reduce the dose of anticoagulants.

In applying Omegaven may appear symptoms of metabolic overload: hepatomegaly with or without jaundice, change or reduction of some parameters of blood coagulation (eg, bleeding time, clotting time, prothrombin time), splenomegaly, anemia, leukopenia, thrombocytopenia, bleeding or a tendency to bleed, change in the functional liver samples, fever, hyperlipidemia, headache, stomach ache, fatigue, giperglikemiâ. Once these side effects occur or triglyceride levels during infusion exceeds 3 mmol / l, the introduction of any fat emulsion should be discontinued or, if necessary, continue its lower rate of administration.

Causes of metabolic overload can be genetic disorders (individual characteristics and metabolic disorders) or lipid metabolism can affect various preceding disease, characterized by varying a rate of lipid metabolism, but this condition is mainly observed when using emulsion based on cottonseed oil.

Overdose

Data on drug overdose Omegaven no.

Drug Interactions

In an application Omegaven with anticoagulants may increase the action of the past.

Pharmaceutical interaction

Omegaven compatible with other fatliquors, incl. drugs with fat-soluble vitamins, as well as water-soluble formulations of vitamins, intended for addition to parenteral nutrition solutions.

Pharmaceutical incompatibility may occur when adding polyvalent cations (eg, calcium), especially in combination with heparin.

Conditions of supply of pharmacies

The drug is approved for use only in a hospital.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C; Do not freeze! Shelf life – 1.5 year.