Composition, form of production and packaging
The emulsion for infusions is white or white with a cream shade, homogeneous.
highly purified fish oil 100 g,
eicosapentaenoic acid 12.5-28.2 g
docosahexaenoic acid 14.4-30.9 g
myristic acid 1-6 g
palmitic acid 2.5-10 g
palmitoleic acid 3-9 g
stearic acid 0.5-2 g
oleic acid 6-13 g
linoleic acid 1-7 g
linolenic acid less than 2 g
octadecatetraenoic acid 0.5-6.54 g
eicosanoic acid 0.5-3 g
arachidonic acid 1-4 g
docosaenic acid less than 1.5 g
docosapentaenoic acid 1.5-4.5 g
D, L -? - tocopherol 0.15-0.296 g
energy value 4700 kJ / l = 1120 kcal / l osmolality 342 В± 10% mOsm / kg H 2 O titratable acidity <1 mmol HCl / l pH 7.5-8.7
Excipients: egg yolk phospholipids - 12 g, glycerol - 25 g, sodium oleate - 0.3 g, sodium hydroxide - qs for pH correction, water d / u - up to 1 l.
50 ml - bottles of colorless glass (10) - cardboard boxes.
50 ml - bottles of colorless glass with plastic holders (10) - cardboard boxes.
100 ml - bottles of colorless glass (10) - cardboard boxes.
100 ml - bottles of colorless glass with plastic holders (10) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
The drug for parenteral use, which contains long-chain omega-3 fatty acids, which are partially included in the lipids of plasma and tissues. 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 the cholesterol content, which improves the fluidity of the membrane. A concomitant increase in the ability to deform blood cells can be an explanation for improving the rheological properties of blood when consuming fish oil or introducing Omegavena. In addition, polyunsaturated fatty acids of the omega-3 family modify the function of membrane enzyme systems, receptors, and impulse transfer.
Omega-3 fatty acids, included in the complex therapy, improve the course of inflammatory bowel diseases, psoriasis, atopic dermatitis, sepsis, burns, postoperative conditions, oncological diseases.
Omegavenum immunomodelling effect: restores the ratio of mediators of inflammation of lipid nature (including prostaglandins, thromboxanes, leukotrienes, cytokines).
The most important are long-chain fatty acids of the omega-3 family: eicosapentaenoic acid (C20: 5? -3) and docosahexaenoic acid (C22: 6-3). The ability of the human body to synthesize eicosapentaenoic and docosahexaenoic acid is very low. Consequently, eicosapentaenoic acid and docosahexaenoic acid must be supplied from the outside naturally through food or IV.
Glycerol contained in Omegavene is used to generate energy or is reesterified along with free fatty acids in the liver with the formation of triglycerides.
Phospholipids of egg yolk are included in cell membranes, being indispensable components for maintaining their integrity, or hydrolyzed.
The therapeutic effect in the / in the pathway of the introduction of omega-3 fatty acids is characterized by a rapid onset of action and high efficacy in acute diseases.
The size of the lipid globules administered with Omegaven and the biological properties are identical to those for physiological chylomicrons in the blood.
In healthy volunteers (men), the half-life of triglycerides administered intravenously with Omegavene was 54 minutes.
- prophylaxis and treatment of insufficiency of omega-3 fatty acids in the complex therapy of inflammatory bowel diseases, sepsis, burns, cachexia (with oncological, cardiological diseases), in the postoperative period, in conditions when enteral administration is limited;
- parenteral nutrition of adults with the inclusion of omega-3 fatty acids, especially eicosapentaenoic and docosahexaeno, when oral or enteral nutrition is impossible, insufficient or contraindicated.
The average daily dose of Omegavena is 1-2 ml / kg of body weight, which corresponds to 100-200 mg of fish oil / kg of body weight. For a patient with a body weight of 70 kg, this is about 70-140 ml of Omegavena. The maximum daily dose is 2 ml / kg of body weight.
The drug is administered by infusion into the central or peripheral vein. The infusion rate should not exceed 0.5 ml / kg / h, which corresponds to 50 mg of fish oil / kg of body weight / h. Do not exceed the maximum infusion rate, otherwise there may be a significant increase in the serum triglyceride concentration. Vial should be shaken before use.
When omegavene is administered with other infusion solutions (eg, amino acid solutions, carbohydrates) through a conventional IV infusion system, compatibility of the solutions and emulsions used must be guaranteed.
From the coagulation system: prolongation of bleeding time and inhibition (slowing) of platelet aggregation.
Other: rarely - a fishy taste in the mouth.
Side effects observed with the infusion of any fat emulsion: a slight increase in body temperature, a feeling of heat and / or cold, chills, hyperemia or cyanosis, anorexia, nausea, vomiting, shortness of breath, headache, chest, back, waist, or decreased blood pressure, anaphylactic reactions (eg, erythema); in isolated cases - priapism.
severe hemorrhagic disorders;
- acute life-threatening conditions, such as collapse and shock, acute stage of myocardial infarction, stroke, embolism, coma of unknown origin;
- allergic reactions to fish or egg white;
General contraindications for parenteral nutrition
Caution should be given to patients who receive anticoagulant therapy, lipid metabolism disorder, uncontrolled diabetes mellitus, patients with severe hepatic or severe renal failure.
PREGNANCY AND LACTATION
Omegavin should not be used during pregnancy and lactation, as there is insufficient data to confirm its safety in these conditions.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to patients with severe renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be given to patients with severe hepatic impairment
APPLICATION FOR CHILDREN
The drug is contraindicated in children.
During the period of application of Omegavena it is recommended to carry out daily monitoring of serum triglyceride concentration. The content of triglycerides in the serum during the infusion of the fat emulsion should not exceed 3 mmol / l.
Regular blood glucose monitoring, acid-base state, water-electrolyte balance, peripheral blood formula and bleeding time should be regularly monitored in patients receiving anticoagulant treatment.
Introduction Omegavena can cause lengthening of bleeding time and inhibition of platelet aggregation. Therefore, omegaven should be administered with caution to patients receiving anticoagulant treatment, and, if necessary, reduce the dose of anticoagulants.
When using omegavena, symptoms of metabolic overload may appear: hepatomegaly with or without jaundice, alteration or decrease in some parameters of blood coagulation (eg, bleeding time, coagulation time, prothrombin time), splenomegaly, anemia, leukopenia, thrombocytopenia, bleeding or tendency to bleeding, change functional hepatic tests, fever, hyperlipidemia, headache, stomach pain, fatigue, hyperglycemia. Once these side effects or triglyceride levels occur during infusion exceed 3 mmol / L, administration of any fat emulsion should be discontinued or, if necessary, continued with a lower injection rate.
The causes of metabolic overload may be genetic disorders (individual characteristics and metabolic disorders) or lipid metabolism may be affected by various previous diseases characterized by a variable rate of lipid metabolism, but this condition is observed mainly when using emulsions based on cottonseed oil.
Data on the overdose of the drug Omegavene is currently not available.
With the simultaneous use of omegavena with anticoagulants, it is possible to enhance the effect of the latter.
Omegavin is compatible with other fat emulsions, incl. with preparations of fat-soluble vitamins, as well as with preparations of water-soluble vitamins, intended for addition to solutions for parenteral nutrition.
Pharmaceutical incompatibility may occur with the addition of polyvalent cations (eg, calcium), especially in combination with heparin.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use only in a hospital.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C; Do not freeze. Shelf life - 1.5 years.