Omegaven

General characteristics. Structure:

Active ingredients: 100 g of high cleaning fish oil (including: eykozapentayenovy acid of 12.5-28.2, dokozageksayenovy acid of 14.4-30.9, myristic acid of 1-6 g, palmitic acid of 2.5-10 g, palmitoleic acid of 3-9 g, stearic acid of 0.5-2 g, oleic acid of 6-13 g, linolic acid of 1-7 g, linolenic acid less than 2 g, oktadekatetrayenovy acid of 0.5-6.54 g, eykozayenovy acid of 0.5-3 g, arachidonic acid of 1-4 g, dokozayenovy acid less than 1.5 g, dokozapentayenovy acid of 1.5-4.5 g, D, L-α-токоферол 0.15-0.296 g); energy value 4700 kJ/l =1120 kcal/l, osmolality of 342±10% ¼Äß¼/kg H2O, titrable acidity <1 mmol of HCl/l, рН 7.5-8.7.

Excipients: phospholipids of an egg yolk, глицерол, sodium oleate, sodium hydroxide - q.s. for correction рН, water for injections.

Pharmacological properties:

Pharmacodynamics. Drug for parenteral use as a part of which long-chain omegas-3-fatty acids which partially join in lipids of plasma and fabrics contain. Dokozageksayenovy acid is an important component of structural phospholipids of cellular membranes, eykozapentayenovy acid - the predecessor for synthesis of eicosanoids: prostaglandins, thromboxanes, leukotrienes and other lipidic mediators.

Family polyunsaturated fatty acids an omega-3 influence biophysical characteristics of cellular membranes by change of composition of phospholipids and content of cholesterol that improves membrane flowability. The accompanying increase in deformability of blood cells can be an explanation of improvement of rheological properties of blood at consumption of fish oil or Omegaven's introduction. Besides, family polyunsaturated fatty acids an omega-3 modify function of membrane fermental systems, receptors, and also momentum transfer.

Omega-3 the fatty acids included in structure of complex therapy improve the course of inflammatory diseases of intestines, psoriasis, atopic dermatitis, sepsis, burns, postoperative states, oncological diseases.

Omegaven renders the immunomodelling effect: recovers ratios of mediators of an inflammation of the lipidic nature (in т.ч prostaglandins, thromboxanes, leukotrienes, cytokines).

Long-chain fatty acids of family an omega-3 are the most important: eykozapentayenovy acid (С20:5ω-3) and dokozageksayenovy acid (С22:6ω-3). Ability of a human body to synthesize eykozapentayenovy and dokozageksayenovy acid very low. Therefore, eykozapentayenovy acid and dokozageksayenovy acid have to arrive from the outside in the natural way with food or in / century.

Glitserol who is contained in Omegavena is used for formation of energy or reesterifitsirutsya together with free fatty acids in a liver with formation of triglycerides.

Phospholipids of an egg yolk join in cellular membranes, being irreplaceable components for maintenance of their integrity, or are hydrolyzed.

The medical effect at in/in a way of administration of fatty acids of family an omega-3 is characterized by quick start of action and high performance at acute diseases.

Pharmacokinetics. The size lipidic глобул, entered with Omegaven, and biological properties are identical to that for physiological chylomicrons in blood.

Healthy volunteers (men) have a period of semi-life of the triglycerides entered in/in with Omegaven made 54 min.

Indications to use:

— prevention and treatment of insufficiency of omegas-3-fatty acids in complex therapy of inflammatory diseases of intestines, sepsis, burns, cachexias (at oncological, cardiological diseases), in the postoperative period, at states when enteral introduction is limited;

— parenteral food of adults with inclusion of omegas-3-fatty acids, especially eykozapentayenovy and dokozageksayenovy when peroral or the enteroalimentation is impossible, is not enough or contraindicated.

Route of administration and doses:

The average daily dose of Omegaven makes 1-2 ml/kg of body weight that corresponds to 100-200 mg of fish fat/kg of body weight. For the patient with the body weight of 70 kg it makes about 70-140 ml of Omegaven. The maximum daily dose - 2 ml/kg of body weight.

The drug is administered by infusion in the central or peripheral vein. Speed of infusion should not exceed 0.5 ml/kg/h that corresponds to 50 mg of fish fat/kg of mass of body/h. It is necessary not to exceed the maximum speed of infusion, otherwise substantial increase of concentration of triglycerides in blood serum can be observed. The bottle before the use should be stirred up.

When Omegaven is entered with other infusion solutions (for example, solutions of amino acids, carbohydrates) through usual system for in/in injections, compatibility of the applied solutions and emulsions has to be guaranteed.

Features of use:

Use at pregnancy and feeding by a breast. Omegaven it is not necessary to apply at pregnancy and in the period of a lactation as there are not enough data confirming its safety at these states.

Use at abnormal liver functions. With care patients should appoint drug with a heavy liver failure

Use at renal failures. With care patients should appoint drug with a heavy renal failure.

Use for children. Drug is contraindicated to children.

Special instructions. During Omegaven's use it is recommended to exercise daily control of concentration of triglycerides of blood serum. Content of triglycerides in serum during infusion of a fatty emulsion should not exceed 3 mmol/l.

It is regularly necessary to control the blood glucose level, an acid-base state, water and electrolytic balance, a formula of peripheral blood and a bleeding time at the patients receiving treatment by anticoagulants.

Omegaven's introduction can cause lengthening of a bleeding time and oppression of aggregation of thrombocytes. Therefore Omegaven the patients receiving treatment by anticoagulants should appoint with care and, if necessary, it is necessary to lower a dose of anticoagulants.

At Omegaven's use symptoms of a metabolic overload can appear: a hepatomegalia with or without jaundice, change or reduction of some parameters of a blood coagulation (for example, a bleeding time, time of coagulation, a prothrombin time), a splenomegaly, anemia, a leukopenia, thrombocytopenia, bleedings or a tendency to bleeding, change of functional hepatic trials, fever, a lipidemia, a headache, a stomach ache, fatigue, a hyperglycemia. As soon as there are these side effects or level of triglycerides during infusion exceeds 3 mmol/l, introduction of any fatty emulsion should be stopped or, if necessary, to continue it with lower rate of administering of drug.

Genetic disorders (specific features and disturbances of metabolism) can be origins of a metabolic overload or various previous diseases which are characterized by the varying speed of metabolism of lipids can influence lipid metabolism, but this state is observed mainly when using emulsions on the basis of cotton oil.

Side effects:

From coagulant system of blood: lengthening of a bleeding time and oppression (delay) of aggregation of thrombocytes.

Others: seldom - fish smack in a mouth.

The side effects observed at infusion of any fatty emulsions: slight increase of body temperature, feeling of heat and/or cold, fever, hyperemia or cyanosis, anorexia, nausea, vomiting, short wind, headache, stethalgia, back, waist, ossalgiya, increase or decrease in the ABP, anaphylactic reactions (for example, erythema); in isolated cases - a priapism.

Interaction with other medicines:

At simultaneous use of Omegaven with anticoagulants strengthening of action of the last is possible.

Pharmaceutical interaction. Omegaven is compatible to other fatty emulsions, including to drugs of fat-soluble vitamins, and also to the drugs of water-soluble vitamins intended for addition in solutions for parenteral food.

Pharmaceutical incompatibility can appear at addition of polyvalent cations (for example, calcium), especially in combination with heparin.

Contraindications:

— heavy hemorrhagic disturbances;

— acute zhizneugrozhayushchy states, such as collapse and shock, acute stage of a myocardial infarction, stroke, embolism, coma of not clear genesis;

— allergic reactions on fish or ovalbumin;

— children's age.

The general contraindications for carrying out parenteral food

— hypopotassemia;

— overhydratation;

— hypotonic dehydration;

— acidosis.

With care should appoint drug the patients who are at the same time receiving anticoagulating therapy at disturbance of metabolism of lipids, an uncontrollable diabetes mellitus, to patients with a heavy liver or heavy renal failure.

Overdose:

Omegaven is not present data on drug overdose now.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C; not to freeze. A period of validity - 1.5 years.

Issue conditions:

According to the recipe

Packaging:

50 ml - bottles of colourless glass (10) - a box cardboard.
50 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.
100 ml - bottles of colourless glass (10) - a box cardboard.
100 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.