Lipofundin infusion MCT/LCT 10% B.Braun provides energy, fat (250ml)

Dosage form 10 bottles
Specifications Soya-Bean Oil, Medium-Chain Triglycerides

Ingredient

Thành phần cho 100ml

Composition informationContent
Soya-Bean Oil5g
Medium-Chain Triglycerides5g

Uses

Indications

Lipofundin MCT/LCT drug is indicated in the following cases:

  • Provides energy because the lipid ingredient is available (MCT). Gastrointestinal tract. For this purpose, Lipofundin MCT/LCT contains medium -chain triglycerides, long chain triglycerides (soybean oil), phosphatide (lecithin in eggs) and glycerol.

    triglycerides have just been hydrolyzed, removed faster from circulation and oxidized completely more completely more triglycerides. Therefore, they are the preferred energy mechanics, especially when there are disorders of deserting or the use of long -chain triglycerides, for example, in the case of lipase lipoprotein deficiency, lipase lipoprotein, carnitine deficiency and decline in carnitine dependent shipping systems.

    Only long -chain triglycerides provide unsaturated fatty acids, so they are mainly used in the disease prevention and the treatment of essential fatty acids and only used as an energy source as a secondary function.

    Besides the function of emulsion for triglycerides, phosphatide is the composition of the cell membrane and ensures their liquid state and biological function.

    glycerol, added with the purpose of providing infection for blood, is the physiological intermediate in the process of metabolism of glucose and lipid: metabolized to bring energy or be used to synthesize glucose, glycogen and triglyceride.

    Pharmacological studies on safety have not disclosed any specific effects compared to the above nutritional effects, like when the special substrates are used by oral.

    pharmacokinetic

    absorption

    Because of the veins, the bioavailability of the components of Lipofundin MCT/LCT is 100%.

    Distribution

    Dosage, injection speed, metabolism and specific elements of each patient (hunger level) are the most relevant factors to determine maximum triglyceride concentration. When used according to the instructions and follow the principle of dosage, triglyceride concentration usually does not exceed 4.6mmol/l.

    Chain fatty acids have low affinity with albumin. Animal experiments for triglyceride emulsion have just pure indicated that the chain fatty acids can overcome the bloodstream barrier if overdose. It is not observed that any adverse effect with emulsion provides a medium -chain triglyceride mixture and long -chain triglyceride because long -chain triglycerides have the effect of inhibiting the medium -chain triglyceride hydrolysis. Therefore, the toxic effect on the brain can be excluded after using Lipofundin MCT/LCT.

    The placenta usually takes non -saturated fatty acids long chain from the mother's blood and regulates the circulation of the fetus. The transfer of fatty acids is a very complicated process associated with many proteins attaching membrane and protein that links floating fatty acids in the cell, although the mechanism is still not sure. The placenta takes the non -ester fatty acids of the mother's blood and the fatty acids released by the lipase lipoprotein and the endothelial lipase of the mother.

    These non -ester fatty acids enter the cells through passive diffusion or by protein transporting membrane. Not estered fatty acids associated with the fatty acid bonding protein in the cell to interact with the cells under the cell, including intracellular, mitochondrial networks, fat drops and peroxisome.

    Metabolism

    After infusion, triglycerides are hydrolyzed into glycerol and fatty acids. Both are included in physiological paths to produce energy, synthesize biological activity molecules, road birth and re -synthesize lipids.

    Elimination

    The semi -disintegration cycle in the plasma of Lipofundin MCT/LCT is about 9 minutes.

    Both triglycerides soybean oil and chain triglycerides have just been completely converted into CO2 and H2O. Only small amounts of lipids in the process of removing cells from the skin and other epithelial membranes. Kidney excretion almost does not occur.

    Pharmacokic

    lipofundin MCT/LCT is used to provide energy and fatty acids ("essential") not as saturated as part of the nutrition on the gastrointestinal tract. For this purpose, Lipofundin MCT/LCT contains medium -chain triglycerides, long chain triglycerides (soybean oil), phosphatide (lecithin in eggs) and glycerol.

    triglycerides have just been hydrolyzed, removed faster from circulation and oxidized completely more completely more triglycerides. Therefore, they are the preferred energy mechanics, especially when there are disorders of deserting or the use of long -chain triglycerides, for example, in the case of lipase lipoprotein deficiency, lipase lipoprotein, carnitine deficiency and decline in carnitine dependent shipping systems.

    Only long -chain triglycerides provide unsaturated fatty acids, so they are mainly used in the disease prevention and the treatment of essential fatty acids and only used as an energy source as a secondary function.

    Besides the function of emulsion for triglycerides, phosphatide is the composition of the cell membrane and ensures their liquid state and biological function.

    glycerol, added with the purpose of providing infection for blood, is the physiological intermediate in the process of metabolism of glucose and lipid: metabolized to bring energy or be used to synthesize glucose, glycogen and triglyceride.

    Pharmacological studies on safety have not disclosed any specific effects compared to the above nutritional effects, like when the special substrates are used by oral.

    pharmacokinetic

    absorption

    Because of the veins, the bioavailability of the components of Lipofundin MCT/LCT is 100%.

    Distribution

    Dosage, injection speed, metabolism and specific elements of each patient (hunger level) are the most relevant factors to determine maximum triglyceride concentration. When used according to the instructions and follow the principle of dosage, triglyceride concentration usually does not exceed 4.6mmol/l.

    Chain fatty acids have low affinity with albumin. Animal experiments for triglyceride emulsion have just pure indicated that the chain fatty acids can overcome the bloodstream barrier if overdose. It is not observed that any adverse effect with emulsion provides a medium -chain triglyceride mixture and long -chain triglyceride because long -chain triglycerides have the effect of inhibiting the medium -chain triglyceride hydrolysis. Therefore, the toxic effect on the brain can be excluded after using Lipofundin MCT/LCT.

    The placenta usually takes non -saturated fatty acids long chain from the mother's blood and regulates the circulation of the fetus. The transfer of fatty acids is a very complicated process associated with many proteins attaching membrane and protein that links floating fatty acids in the cell, although the mechanism is still not sure. The placenta takes the non -ester fatty acids of the mother's blood and the fatty acids released by the lipase lipoprotein and the endothelial lipase of the mother.

    These non -ester fatty acids enter the cells through passive diffusion or by protein transporting membrane. Not estered fatty acids associated with the fatty acid bonding protein in the cell to interact with the cells under the cell, including intracellular, mitochondrial networks, fat drops and peroxisome.

    Metabolism

    After infusion, triglycerides are hydrolyzed into glycerol and fatty acids. Both are included in physiological paths to produce energy, synthesize biological activity molecules, road birth and re -synthesize lipids.

    Elimination

    The semi -disintegration cycle in the plasma of Lipofundin MCT/LCT is about 9 minutes.

    Both triglycerides soybean oil and chain triglycerides have just been completely converted into CO2 and H2O. Only small amounts of lipids in the process of removing cells from the skin and other epithelial membranes. Kidney excretion almost does not occur.

    • Before taking Lipofundin infusion MCT/LCT 10% B.Braun provides energy, fat (250ml)

    How to use

    Intravenous injection drugs.

    Shake gently before use.

    Lipid emulsion is suitable for use in peripheral veins and can also be used separately through peripheral veins as part of the venous nourishment.

    Must set a Y -connector or a connection as close to the patient as possible, if the lipid emulsion is used simultaneously with amine and carbohydrate acid solutions.

    Time to use Lipofundin MCT/LCT is usually 1-2 weeks. If nourished by intravenous lines by lipid emulsion is further specified, may be used for lipofundin MCT/LCT for a longer time as long as there is appropriate tracking.

    Dosage

    is only given the maximum daily dose after increasing step by step with careful monitoring of the ability to tolerate transmission.

    Depending on the energy requirements, the following daily doses are recommended:

    Adults

    Normal dose is 0.7 - 1.5g lipid/kg per day.

    Do not exceed the maximum dose of 2.0g lipid/kg/day, for example, high energy requirements or fat use (such as cancer patients). For long -term venous nurturing treatment at home (> 6 months) and in patients with short bowel syndrome, lipid transmission in veins must not exceed 1.0g/kg/day. For patients weighing 70kg, the daily dose is 2.0g/kg/day corresponding to the maximum daily dose of 1400ml of Lipofundin MCT/LCT.

    Pediatric group

    Increase the amount of lipids introduced at an increase of 0.5 - 1.0g/kg/day may benefit the ability to monitor the increase in plasma triglycerides and prevent excess blood lipids.

    Infants lack monthly, newborn babies, newborns and children to practice: recommend not to exceed the daily dose of 3.0g (maximum 4.0g)/kg/day for lipids.

    In newborn babies, newborn babies, newborns and children to practice, daily lipid dose must be transmitted continuously for 24 hours.

    children and adolescents

    The recommendation does not exceed the daily lipid dose of 2.0 - 3.0g/kg/day.

    Transmission speed

    Must transmit at the lowest transmission speed possible. In the first 15 minutes, the transmission speed should only be equal to 50% of the maximum transmission speed to be used.

    Must monitor patients closely to see if there is a adverse reaction.

    Maximum transmission speed

    Adults

    up to 0.15g/kg/hour for lipid.

    For a patient weighing 70kg, this number is equivalent to the maximum transmission speed of 105ml of Lipofundin MCT/LCT 10% per hour. The amount of lipid used is 10.5g per hour.

    Infants lack monthly, newborn babies, newborns and children to practice

    up to 0.17g/kg/hour for lipid.

    Children and adolescents

    up to 0.13g/kg/hour for lipid.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose?

    Symptoms

    hyperlipidemia, metabolic acidosis. In addition, fat overload syndrome may appear.

    Treatment

    Stop transmitting as soon as there are signs of overdose. Other treatments will depend on their specific symptoms and their severity.

    After the symptoms have decreased, the infusion is recommended, so the transmission rate should be monitored at regular periods.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Lipofundin MCT/LCT, you may experience unwanted effects (ADR).

    Very rare, ADR

  • Blood and lymphatic system: increased blood clotting.
    • immune: allergic reactions (such as anaphylactic reactions, skin rash, laryngeal edema, mouth and face). Metabolic and nutrition: hyperlipidemia, hyperlem of blood glucose, metabolic acidosis, ceton - acid infection.
  • nerve: headache, drowsiness.
    • blood vessels: increase or lower blood pressure, blush.
  • Respiratory, chest and mediastinum: Difficulty breathing, purple blue.
    • digestive: nausea, vomiting, anorexia.
  • Skin and subcutaneous tissue: Red rash, sweating.
  • muscle, bone and connective tissue: back pain, bones, chest and lumbar region.
  • At the place of use: Increased body temperature, feeling cold, chilling, fat overload syndrome.

    • Unknown frequency

  • Blood and lymphatic system: leukopenia, thrombocytopenia.

    • Molecularity: cholestasis.

    Fat overload syndrome

    Overdose of lipid emulsion or decline in the ability to clear triglycerides may lead to "fat overload syndrome". Must observe the possible signs of metabolic overload.

    Fat overload syndrome is characterized by increased blood lipids, fever, fat, liver with or without jaundice, enlarged spleen, anemia, leukopenia, platelet reduction, blood clotting disorders, hemolysis and mesh hyperbody, abnormal liver function tests and coma.

    Instructions on how to handle ADR

    Notify the doctor with unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Lipofundin MCT/LCT is contraindicated in the following cases:

  • Too hypersensitivity to egg protein or soybean, soybean products or peanuts or any active ingredients or excipients.

    • Severe blood lipid increase.

  • Severe coagulation disorders.
    • Severe liver failure.

    Molecularity in the liver.

    Severe renal failure without kidney replacement therapy.

  • Acute thrombosis.

    • Fat vessels.

  • Tibbed bleeding is aggravated.

    • Metabolic acidosis.

    General contraindications for intravenous nurturing include: Unstable circulatory condition is life -threatening (collapse and shock), unstable metabolic conditions, acute phases of myocardial infarction or stroke), disorders of fluid and electrolytes are not adjustable, such as hypotension and dehydration, acute loss of water.

    Precautions when used

    Serly triglyceride concentration must be monitored regularly during Lipofundin MCT/LCT.

    Depending on the patient's metabolic conditions, there may occur in hyperklyceride. If plasma triglyceride concentration exceeds 4.6mmol/l during lipid emulsion transmission, the transmission speed should be reduced. The transmission process must be temporarily suspended if the plasma triglyceride concentration exceeds 11.4mmol/l.

    Must adjust the disorders of fluid, electrolytes or acid - base before starting the infusion.

    It is necessary to control the balance of electrolytes in serum, fluid, acid - base, cardiovascular function and in the long -term transmission of blood cells, blood clotting and liver function.

    Hypersensitivity reactions with an component of Lipofundin MCT/LCT (for example, due to the trace of protein in soybean or lecithin in eggs) is extremely rare, but cannot be completely excluded for sensitive patients. Lipofundin MCT/LCT must be stopped immediately in the event that any signs of allergic reactions appear, such as fever, cold, rash, shortness of breath.

    Providing energy with only lipid emulsion can cause metabolic acidosis. Therefore, the amount of carbohydrates and amino acids should be adequate in the vein with fat emulsion.

    For patients who need to be completely nourished through the vein, it is necessary to use carbohydrates, amino acids, electrolytes, vitamins and trace elements. In addition, must ensure adequate total translation.

    Mixing with incompatible substances can lead to the decomposition of emulsion or precipitating elements, both of which lead to high risk of vascular obstruction.

    In solutions with higher lipid content (eg lipofundin MCT/ LCT 20%), the ratio of emulsifier (phospholipid) on oil is lower than in lipid emulsion with lower content. This ensures the concentration of triglycerides, phospholipids, free fatty acids as well as lipoprotein - X causing lower plasma diseases. Therefore, priority should be given to lipid emulsion with higher content such as Lipofundin MCT/LCT 20% compared to lower lipid emulsion.

    Be careful in patients with other diseases such as heart failure or kidney failure, diseases often related to high age.

    Lipofundin MCT/LCT must be used carefully in patients with signs of lipid metabolism disorders, such as kidney failure, diabetes, pancreatitis, impaired liver function, hypothyroidism (hyperioderide blood) and blood infection. If using Lipofundin MCT/ LCT in these patients, serum triglycerides should be closely monitored. The dose must be adjusted according to the metabolic tolerance level. Increasing blood triglyceride 12 hours after lipid transmission also shows lipid metabolic disorders.

    Free fatty acids (FFA) compete with bilirubin at albumin link positions. In particular, children who are born in a monthly risk may have a higher risk of excess bilirubin because high FFA levels are released from triglycerides, leading to high FFA/albumin ratio. In infants nourished by intravenously, there is a risk of excess blood bilirubin, the level of triglycerides and serum bilirubin must be monitored and must adjust the lipid transmission speed if necessary. In the process of transmitting Lipofundin MCT/LCT, it must be protected to avoid the light of therapy to reduce the formation of triglycerides hydroperoxide.

    Serly triglycerides must be monitored regularly during the process of lipofundin MCT/LCT, especially if there is a high risk of increasing blood lipids. Maybe the dose should be gradually increased every day.

    Depending on the patient's metabolic conditions, there may occur in hyperklyceride. In babies, the dose should be considered if the plasma triglyceride concentration during the transmission process exceeds 2.8mmol/l. In older children, the dose should be considered if the plasma triglyceride levels during the transmission process exceeds 4.5mmol/l.

    Lipid can affect certain tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when taking blood samples before lipid is cleared from blood, this process may take 4 to 6 hours.

    The ability to drive and operate machinery

    does not affect.

    Pregnancy

    No data or limited data from the use of Lipofundin MCT/LCT in pregnant women. Animal data is incomplete to toxicity for the reproductive system.

    Nursing through intravenously may be necessary during pregnancy. Only for Lipofundin MCT/LCT in pregnant women after considering the benefits - the risk of careful.

    Breastfeeding period

    The components/metabolites of Lipofundin MCT/LCT are secreted into breast milk, but at the dose of treatment, there is no impact on infant breastfeeding. In general, mothers who receive nutrition by vein should not breastfeed.

    Drug interaction

    heparin

    Heparin is used in clinical doses that cause temporary liberation of lipoprotein lipase into the blood. This may initially lead to an increase in plasma lipid resolution, then the most relieved news of Triglyceride clearance.

    Coumarin's derivatives

    Soybean oil has a natural content of vitamin K1. However, this content is very low in the Lipofundin MCT/LCT that it does not significantly affect the blood clotting process in patients treated with Coumarin derivatives. But blood clotting must be monitored in patients treated simultaneously with Coumarin.

    Storage

    Do not be stored above 25 ° C.

    Do not freeze.

    Store bottles in cartons to avoid light.

    When using the product in a flexible bag, it is necessary to clog the ventilation places.

    If using filters, these filters must be able to absorb Lipid.

    Before using a lipid emulsion with other solutions via a Y or a connection, it is necessary to check the compatibility of these liquids, especially when using the transmission solution with the additional medicine. It is necessary to be particularly cautious when transmitting solutions containing valence electrolytes at the same time (such as calcium or magnesium).

    emulsion must be brought to room temperature naturally before transmission, which means not putting the product into a warming device (such as an oven or microwave oven).

    Use only once. Must cancel any unused emulsion.

    must cancel the product that has been frozen.

    Only use when the packaging is not damaged and the inside contains emulsion in the homogeneous form and is milky white. Check with emulsion eyes to see if there is a phase separation or not before using.

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