Omegaven (Omegaven)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Similar drugsTo uncover
Dosage form: & nbsp
emulsion for infusions
Composition:

1 liter of emulsion contains:
Active Ingredients:
Highly purified fish oil 100 g containing:
-icosapentaenoic acid 12.5-28.2 g
-docosahexaenoic acid 14.4-30.9 g
-myristic acid 1.0-6.0 g
-palmitic acid 2.5-10.0 g
-Palmitoleic acid 3.0-9.0 g
-stearic acid 0.5-2.0 g
-oleic acid 6.0-13.0 g
-linoic acid 1.0-7.0 g
-linolenic acid less than 2.0 grams
-oxadecatetraenoic acid 0.5-6.54 g
-Aicosanoic acid 0.5 - 3.0 g
-Arachidonic acid 1.0 - 4.0 g
-docosanoic acid less than 1.5 grams
docosapentaenoic acid 1.5 - 4.5 g
d, l-α-tocopherol 0.150 -0.296 g

Other Ingredients:

egg yolk phospholipids 12.0 g

glycerol 25.0 g

sodium oleate 0.3 g

sodium hydroxide (for pH correction) q.s.

water for injection up to 1 liter

The energy value of 4700 kJ / l = 1120 kcal / l

Osmolality 342 ± 10% mOsm / kg H20

Titrated acidity <1 mmol HC1 / L

pH 7,5-8,7

Description:White or white with a cream shade homogeneous emulsion.
Pharmacotherapeutic group:Means for parenteral nutrition
Pharmacodynamics:Long-chain omega-3 fatty acids are partially included in 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 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 improve the therapy of pathological disorders in premature infants, as well as inflammatory bowel diseases, psoriasis, atopic dermatitis, sepsis, burns, postoperative conditions, and oncological diseases. Omegavenum immunomodulating: restores the ratio of lipid mediators of inflammation (including prostaglandin, thromboxanes, leukotriene, cytokines). The most important are long-chain fatty acids of the omega-3 family: eicosapentaenoic acid (C20: 5ω-3) and docosahexaenoic acid (C22: 6ω-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 externally in a natural way with food or intravenously.
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.
Pharmacokinetics: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. The therapeutic effect of intravenous administration of omega-3 fatty acids is characterized by a rapid onset of action and high efficacy in acute diseases.
Indications:
- prevention and treatment of insufficiency of omega-3 fatty acids in the complex therapy of inflammatory bowel diseases, sepsis, burns,cachexia (with oncological, cardiological diseases, etc.), and in postoperative conditions with deficiency of omega-3 fatty acids.
- parenteral nutrition for adults with the inclusion of omega-3 fatty acids, especially eicosapentaenoic and docosahexaeno, when oral or enteral nutrition is impossible, insufficient or contraindicated.
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
- Omegavene should not be used in patients with an allergy to fish or egg white.
- Childhood.
General contraindications for parenteral nutrition: hypokalemia, hyperhydration, hypotonic dehydration, acidosis.
Carefully:Intravenous administration of Omegavena can cause prolongation of bleeding time and inhibition of platelet aggregation. Therefore, omegaven should be administered with caution to patients who need anticoagulant therapy, even taking into account the possible reduction in the dose of these drugs.Omegavene 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.
Pregnancy and lactation:Omegaven should not be used during pregnancy and lactation, as there is insufficient data to confirm its safety in these conditions.
Dosing and Administration:
Dosage regimen, mode of administration, if necessary, the time of taking the drug, the duration of treatment (including in children before and after one year)
For infusion into the central or peripheral vein. Vial should be shaken before use. When Omegavn is assigned / used with other infusion media (eg amino acid solutions, carbohydrates) through the usual system for intravenous infusions, compatibility of the solutions and emulsions used must be guaranteed.

Daily dose: 1-2 ml of Omegavena 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 Omegavena for a patient weighing 70 kg.

The 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. Do not exceed the maximum infusion rate, otherwise there may be a significant increase in the serum triglyceride concentration.

Omegavene can be administered simultaneously with other fat emulsions. Based on the recommended total daily intake of fat equal to 1-2 g / kg body weight, the proportion of fish oil administered with Omegaven should be 10-20% of this intake.

Side effects:

- Intravenous administration of omegavena may lead to prolonged bleeding time and inhibition (slowing) of platelet aggregation.

- In rare cases, patients may feel a fishy taste in their 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; pain in the chest, back, waist, ossalgia; priapism (in very rare cases), increased or decreased blood pressure, anaphylactic reactions (eg, erythema).

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.

Overdose:
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 variable rate of lipid metabolism, but this condition is observed mainly when using emulsions based on cottonseed oil.
Metabolic overload may be manifested by the following symptoms: hepatomegaly with or without jaundice, alteration or decrease in certain blood clotting parameters (eg, bleeding time, clotting time, prothrombin time, platelet count), splenomegaly, anemia, leukopenia, thrombocytopenia, bleeding or tendency to bleeding, changes in functional hepatic tests, fever, hyperlipidemia, headache, stomach pain, fatigue, hyperglycemia.
Interaction:
Intravenous administration of Omegavena can cause prolongation of bleeding time and inhibition of platelet aggregation. Therefore, omegaven should be administered with caution to patients who need anticoagulant therapy, even taking into account the possible reduction in the dose of these drugs.
Omegavene can only be mixed with preparations of fat-soluble vitamins (Vitalipid H) and water-soluble vitamins (Soluvit H) and other fat emulsions (Intralipid, Lipovenosis, etc.).
Incompatibility: Incompatibility may appear when adding polyvalent cations (eg, calcium), especially in combination with heparin.
Special instructions:
Special Precautions
It is recommended to carry out a daily monitoring of the serum triglyceride concentration. The content of triglycerides in the serum during the infusion of the fat emulsion should not exceed 3 mmol / l. Regularly monitored: blood glucose level, acid-base state, water-electrolyte balance, blood test and bleeding time in patients receiving anticoagulant treatment.
Form release / dosage:
Emulsion for infusion.
Packaging:
To 50 or 100 ml in a bottle of colorless glass, ukuporenny rubber (halobutilovoy) stopper and obkatanny aluminum caps with a plastic cap-control the first dissection. For 10 vials, together with plastic holders or without them in a carton box with instructions for use.
Storage conditions:Store at a temperature of no higher than 25 ° C. Do not freeze! Keep out of the reach of children!
Shelf life:
1,5 years.
Do not use after expiry date.
Terms of leave from pharmacies:For hospitals
Registration number:LS-002225
Date of registration:21.11.2011
Expiration Date:Unlimited
The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
Manufacturer: & nbsp
Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
Information update date: & nbsp06.06.2017
Illustrated instructions
    Instructions
    Up