active ingredients: 1000 ml solution contains 60 g soy refined oil, 60 g medium chain triglycerides, 50 g olive refined oil, 30 g fish oil purified;
excipients: egg yolk phospholipids, glycerin, DL-?-tocopherol, sodium oleate, sodium hydroxide (for pH correction), water for injection.
Dosage form. Emulsion for infusion.
Pharmacological group. Solutions for parenteral nutrition. Fat emulsion. PBX code V05VA02.
Smoflipid is a source of energy, essential fatty acids and omega-3 fatty acids for patients with parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated.
Hypersensitivity to fish, egg, soybean proteins or to any of the active or excipients; severe hyperlipidemia, severe liver insufficiency severe blood coagulation disorders; severe renal insufficiency without dialysis or hemofiltration; acute shock General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure unstable condition (for example, after severe injuries, decompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).
Intravenous infusion in the Central or peripheral veins.
the Standard dose is 1-2 g fat/kg/day, corresponding to 5-10 ml/kg body weight/day. The recommended infusion rate -0,125 g of fat/kg/h, which corresponds to 0.63 ml smoflipid the 20%/kg/h and should not exceed 0.15 g fat/kg/h, which corresponds to 0.75 ml of Smoflipid 20%/kg/hour. TheNewborns and infants.
the Starting dose should be 0.5-1 g of fat/kg per day, followed by a consistent increase of 0.5-1 g of fat/kg per day. It is recommended not to exceed a daily dose of 3 g fat/kg/day, which corresponds to 15 ml of Smoflipid 20%/kg per day. The rate of infusion should not exceed 0.125 g fat/kg/hour.
Premature and newborn infants with low weight should be administered continuously for 24 hours.
it is Recommended not to exceed a daily dose of 3 g fat/kg/day, which corresponds to 15 ml of Smoflipid 20%/kg per day. The daily dose should be increased gradually during the first weeks. The rate of infusion should not exceed 0.15 g fat/kg/hour.
after the use of the drug, adverse reactions were observed with such a frequency: very often (> 1/10;) often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000).
the part of the respiratory system:
rarely shortness of breath.
from the digestive system:
Infrequently: lack of appetite, nausea, vomiting.
the part of the vascular system:
Rare: arterial hypotension, hypertension.
General adverse reactions and reactions at the injection site:
Often a slight increase in body temperature.
Infrequent: feeling cold.
Rare hypersensitivity reactions (anaphylactic reactions, skin rashes, urticaria, redness, headache), sensation of heat or cold, pallor, cyanosis, pain in the neck, back, bones, chest and lower back.
on the part of the reproductive system:
very rarely priapism.
In the event of adverse reactions to the infusion Smoflipid 20% should be discontinued or the dose radovitskiy.
If the level of triglycerides during infusion rises above 3 mmol/l, introduction to Smoflipid 20% you need to stop or, if necessary, radovitskiy dose.
in treatment, along with amino acids and glucose, 20% of Smoflipid should always be part of a comprehensive parenteral diet. Nausea, vomiting and hyperglycemia are symptoms that are associated with parenteral nutrition conditions.
it is Recommended to monitor triglyceride and blood glucose levels to avoid elevated levels that may be dangerous.
fat overload Syndrome: breaking the potential to eliminate triglycerides can lead to fat overload syndrome. It is necessary to monitor this manifestation, which may occur as a result of overdose. Also, the cause of the syndrome may be a genetically determined individual feature of metabolism, diseases with a violation of fat metabolism or illness. The syndrome may also appear in severe hypertriglyceridemia, even at the recommended rate of infusion, and in connection with a sharp change in the clinical condition of the patient: renal failure or infection.
fat overload Syndrome characterizes hyperlipemia, fever, fatty infiltration, hepatomegaly including jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders, hemolysis and reticulocytosis, impaired liver function and coma.
in case of signs of fatty overload syndrome infusion should be stopped.
Overdose can cause symptoms of fat overload in case of too rapid infusion or prolonged infusion with the recommended speed in connection with changes in the clinical condition of the patients, such as the occurrence of liver failure or infection.
Overdose can lead to side effects. In these cases, the infusion of lipids should be stopped or, if necessary, continue to reduce the dose.
there is No data on the impact of Smoflipid 20% during pregnancy and lactation. There are no studies of reproductive toxicity. Smoflipid 20% should be used in pregnant and breastfeeding, after a thorough examination. The drug should be prescribed only when the expected beneficial effect for the mother exceeds the potential risk to the fetus.The
Used in pediatric practice (see "Method of application and dosage").
the Potential for elimination of fat is individual, and therefore we need to control the level of triglyceridemia. Particular caution should be used in patients with a pronounced risk of hyperlipidemia (e.g. patients with high lipid dosage, severe sepsis, newborns with low body weight at birth). The concentration of triglycerides in serum, as a rule, does not exceed 3 mmol/l with infusion. Dose reduction or cessation of supplies of fat emulsion should be considered if the concentration of triglycerides in serum or plasma during or after infusion of more than 3 mmol/L. Overdose can cause fat overload syndrome.
This medicinal product contains soya oil, fish oil and egg yolk phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya beans and peanuts.
Smoflipid 20% should be used with caution in conditions of impaired lipid metabolism, which may occur in patients with hepatic insufficiency, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.
Clinical data for patients with diabetes or with liver failure obmezheniy.
the Use of medium-chain fatty acids may lead to metabolic acidosis. This risk is largely possible to eliminate the simultaneous introduction of long-chain fatty acids included in Smoflipid 20%. Simultaneous use of carbohydrates helps to eliminate this threat.
thus, simultaneous administration of carbohydrates containing amino acids is recommended. Laboratory studies, mainly related to the monitoring of intravenous nutrition, should be carried out regularly. These include checking the level of glucose in the blood, liver function, acid base metabolism, fluid balance, total blood count and electrolytes. With any symptom of anaphylactic reaction (eg, fever, chills, rash, shortness of breath) should immediately stop infusion.
Smoflipid 20% should be carefully used in newborns and premature babies, novorocement hyperbilirubinemia and cases with pulmonary hypertension. Newborns, especially premature infants, parenteral nutrition which is scheduled for a long time, you should check the blood counts for platelets, liver function tests, and samples of serum triglycerides.
High levels of lipids in the blood plasma may affect some laboratory blood tests such as the hemoglobin level.
use of the drugs along with Smoflipid 20% generally should be avoided except where compatibility is known.The
has No effect.The
the use of heparin in clinical doses causes a temporary increase in lipoproteins in the bloodstream. First, it can lead to a temporary increase in plasma lipolysis, and then to a decrease in triglyceride levels.
Smoflipid 20%, following aseptic conditions, can be mixed with amino acid, glucose and electrolyte solutions, preparing a solution for complete parenteral nutrition "All in one".The
Pharmacodynamics.Share of the fat emulsion are of a size and biological properties similar to endogenous HMM. Smoflipid 20% is a source of energy. Soybean oil with a high content of essential fatty acid. Omega-6 fatty acid and linoleic acid are Nabilosat (55-60%). Alpha-linoleic acid and omega-3 fatty acids make up almost 8%. This part of Smoflipid 20% provides the necessary amount of essential fatty acids, which are rapidly oxidized and provide energy. Olive oil mainly provides energy in the form of monounsaturated fatty acids, which are less prone to peroxidation than the corresponding polyunsaturated fatty acids. Fish oil is characterized by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, while ERA is a precursor to eicosanoids like prostaglandins, thromboxane and leukotrienes.
Vitamin E protects unsaturated fatty acids from lipid peroxidation.
Pharmacokinetics.separate triglycerides have different withdrawal rates, but the Smoflipid 20% as a mixture is excreted faster than long chain triglycerides (lcts) during infusion. Olive oil has the slowest output rate than other components (not slower than LCT), and with average triglyceride (MST) - high speed. Fish oil mixed with LCT has the same output rate as when applied separately.
a homogeneous white emulsion.The
Drug should not be mixed with other medicinal products except those mentioned in section "Interactions with other medicinal products and other forms of interaction".The
2 years old.
Keep out of reach of children at temperature not above 25 ° C. do not freeze.
storage Period after the first wickramathilaka not more than 24 hours at 2-8 ° CThe
Glass bottle of 100 ml, 250 ml or 500 ml,№1 ABO № 10, in a cardboard box.The
According to the recipe.The
Fresenius Kabi Deutschland GmbH.The
Elsa-Kroner-Strasse, 1, 61352, bad Homburg, Germany.The
Fresenius Kabi Austria GmbH.The
Hafnerstra?e 36, 8055 Graz, Austria.
Contrive – drugs, characterized by Antihemorrhagics impact. The active substance is Aprotinin, the therapeutic effect of which lies in the blockade of plasminogen.
the Tool is used when:
the procedure by blood transfusion. The
the Preparation has the form of a solution for intravenous or infusion application. Before use, it is recommended to conduct a test test on the allergic reaction of the body by using the lowest dosage in the amount of 10 ml.the Remedy must be administered slowly in the supine position of the patient.
the Standard rate is not more than 350 000 ED, with doses administered later should not exceed 140 000 ED. The interval between the injection – at least 4 hours. The duration of therapy is determined by the patient's history and risk of bleeding, the standard course is 3-6 days.