Active material: soybean oil, triglycerides medium chain, olive oil, purified fish oil
When ATH: B05BA02
CCF: The preparation for parenteral nutrition – fatliquor
When CSF: 21.08.03
Manufacturer: FRESENIUS KABI GERMANY GmbH (Germany)
Smoflipid: dosage form, composition and packaging
Emulsion for infusion 20% Homogeneous, white.
|soybean oil (Refined)||60 g|
|triglycerides medium chain||60 g|
|olive oil (Refined)||50 g|
|purified fish oil||30 g|
|energy value 2000 kcal / l (8.4 MJ / l)|
Theoretical osmolarity 380 mOsm / kg H2ABOUT
Excipients: egg yolk phospholipids, glycerol bezvodnыy, D,L-a-токоферол, sodium oleate, Sodium hydroxide (to maintain pH 8), water d / and.
100 ml – colorless glass vials (10) – cardboard boxes.
250 ml – colorless glass vials (10) – cardboard boxes.
500 ml – colorless glass vials (10) – cardboard boxes.
Smoflipid: Pharmacological properties
Farmakodinamika. Smoflipid is a source of energy and essential fatty acids, including omega-3-fatty acids, during parenteral nutrition or correction deficiency of essential fatty acids.
Pharmacokinetics. Size lipidnыh globul, introduced with the emulsion Smoflipida, and biological properties are identical to those for physiological hilomikronov in plasma.
• full or partial parenteral nutrition as a source of energy and essential fatty acids, including omega-3-fatty acids, when oral or enteral nutrition is impossible, insufficient or contraindicated;
• Prevention and treatment of failure (deficit) essential fatty acids, including omega-3-fatty acids.
Before using the product, you must read the instructions. Apply for infusion in Central or peripheral vein. The dose and rate of infusion should be determined by the ability of the patient to eliminate the input / in lipids (cm. Cautions).
Standard adult dose of 1-2 g fat/kg body weight/day, that corresponds to 5-10 mL/kg/day.
The maximum daily dose: 2 g fat/kg/day, corresponding 10 mL/kg/day.
The recommended infusion rate is 0,125 g fat/kg body weight/h, corresponding 0,63 mL/kg/h, Smoflipida. The infusion rate should not exceed 0,15 g fat/kg/h, corresponding 0,75 mL/kg/h, Smoflipida.
Newborn initial dosage is 0.5-1.0 g fat/kg/day, followed by increasing the dose of 0.5-1.0 g fat/kg/day until 3,0 g fat/kg/day.
Do not exceed the recommended daily dose 3 g fat/kg/day, corresponding 15 ml Smoflipida/kg/day.
Dose infusion should not exceed 0,125 g/kg/h.
In premature and newborn babies are underweight, Smoflipid should be continuously about 24 no.
Children do not exceed recommended dose 3 g fat/kg/day, corresponding 15 ml Smoflipida/kg/day.
Daily dose should be increased gradually over a 1-week appointment.
Infusion rate should not exceed 0,15 g fat/kg/h.
• known hypersensitivity to the fish, egg or soy protein, or to the drug. Severe hyperlipidemia. Severe hepatic impairment.
General contraindications for parenteral nutrition:
• severe blood coagulation disorders nekorrigiruemye;
• severe renal insufficiency without the possibility of haemofiltration or hemodialysis, shock.
General contraindications to infusion therapy: acute pulmonary edema, gipergidratatsiya, decompensated heart failure, unstable states (acute myocardial infarction, stroke, embolism, severe metabolic acidosis, hypotonic dehydration).
Smoflipid: SIDE EFFECTS
Rarely (≤1%): slight fever, chills, nausea, decreased appetite.
Rarely (≤0,1%): hypersensitivity reactions (such as anaphylactic reactions, skin rash, hives, hyperemia, headache), sensation of heat or cold, paleness, cyanosis, pain in the neck, back, Breast, loin, hypotension, AG, breathlessness.
As soon as these side effects occur or TG during infusion 4 mmol / l, the introduction of any fat emulsion should be discontinued or, if necessary, continue at a slower rate of administration.
Smoflipid: Special instructions
The ability to eliminate fat is individual, therefore advisable to check the level of triglycerides. With the introduction of any fatty emulsions TG concentrations in plasma during the infusion should not exceed 3-4 mmol/l.
Excessive introduction only medium chain fatty acids may lead to metabolic acidosis. This risk is significantly reduced when applying Smoflipida by reducing the share of medium chain triglycerides of fatty acids and the introduction of long-chain fatty acids. When injecting nutrition as energy sources recommend the simultaneous introduction of carbohydrates.
Smoflipid should be administered with caution in conditions, characterized by lipid disorders, which may develop in patients with renal insufficiency, diabetes, pancreatitis, severe hepatic insufficiency, gipotireozom.
Pregnancy and breast-feeding. Special controlled clinical studies on the use of drugs during pregnancy and lactation did not, therefore, use of the drug in these patients is possible with a thorough assessment of risk / benefit ratio.
Heparin in therapeutic doses causes a transient increase in the release of lipoprotein lipase into the bloodstream. Initially, this can lead to increased plasma lipolysis, and then temporarily reduce clearance of TG. Soybean oil is a natural source of vitamin K1. However, the content of this vitamin in Smoflipide has no significant effect on the process of blood clotting in patients, treated with coumarin derivatives. Smoflipid can be mixed with preparations fat-soluble vitamins (Vytalypyd) and water-soluble vitamins (Soluvit). When using Smoflipida other infusion media (such as p-set of amino acids, Glucose) through the usual system for / in infusions, compatibility must be guaranteed used RV-ERS and emulsions.
Reduced ability to eliminate triglycerides can lead to fat overload syndrome, which may be caused by an overdose of any fatliquors. It is necessary to observe the condition of the patient with respect to signs of possible metabolic overload. The reason may be genetic (Unlike individual metabolism), or the exchange of fat may affect existing now or earlier diseases. This syndrome may also develop during severe hypertriglyceridemia, even at the recommended infusion rate, and accompanied by a sudden change in the clinical status of the patient, such as the development of renal failure or the addition of an infection. Fat overload syndrome is characterized by hyperlipidaemia, fever, fatty infiltration, hepatomegaly with or without jaundice, splenomegaly, leukopenia, thrombocytopenia, blood clotting disorders, gemolizom, reticulocytosis, the pathological results of functional liver tests and development of coma. Termination of infusion of the fat emulsion leads to disappearance of all symptoms.
Smoflipid: STORAGE CONDITIONS
At a temperature of no higher than 25° c. Do not freeze!