Lipofundin infusion MCT/LCT 10% B.Braun provides energy, fat (500ml)

Dosage form 10 bottles x 500ml
Specifications Medium-Chain Triglicerides, Soybean Oil

Ingredient

Thành phần cho 100ml

Composition information	Content
Medium-Chain Triglicerides	5g
Soybean oil	5g

Uses

Indications

500ml Braun Lipofundin is indicated in the following cases:

Provides energy because the lipid ingredient is available (MCT).

Lipofundin MCT/LCT is used to provide "essential" multiple "essential" fatty energy and acids as part of the digestive nutrition. 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 deserted and /or the use of long -chain triglycerides, for example, in the case of Lipase Lipoprotein deficiency, lack of lipase lipoprotein, carnitine deficiency and Carnitine dependent shipping system.

Only long -chain triglycerides provide unsaturated fatty acids, so they are mainly used in disease prevention and treat essential fatty acids and are 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 is added with the purpose of providing emulsion is the blood of the blood, which 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 triglycerides.

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.

Pharmacokinetics

absorption

Biochemistry: Because the use of 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 4.6 mmol/l.

Chain fatty acids have low affinity with albumin. Animal experiments for pure chain triglycerides show that the chain fatty acids can overcome the bloody 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 -estered fatty acids of the mother's blood and the fatty acids released by 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. The non -estered fatty acid is associated with protein that binds floating fatty acids 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 (500ml)

How to use

Intravenous infusion.

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 whole nourishment through the vein.

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

Time to use Lipofundin® MCT/LCT 10% is usually 1-2 weeks. If nourished by intravenous lines with lipid emulsion is added, it can be used for lipofundin® MCT/LCT 10% for 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.

The use of lipids in veins depends on the severity of the disease available, the form of the gestational and the age of postpartum and the specific functions of the body.

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

Adults

The normal dose is 0.7 to 1.5 g of lipid/kg body weight (tt) per day. Do not exceed the maximum dose of 2.0 g lipid/kg TT/day, for example, high energy requirements or when increased 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 1.0 g/kg body weight/day.

For patients weighing 70 kg, daily dose is 2.0 g/kg body weight/day corresponding to the maximum daily dose of 1400 ml of lipofundin® MCT/LCT 10%.

Pediatric group

Gradually increase the amount of lipids put in at an increase of 0.5 - 1.0 g/kg body weight/day may benefit the ability to monitor the increase in plasma triglyceride levels and prevent excess lipids.

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

The recommendation must not exceed the daily dose of 3.0 (maximum 4.0) g/kg body weight/day for lipid.

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 - 3.0 g/kg body weight/day

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. See the "Unwanted effects" section.

Treatment

Stop transmitting as soon as there are signs of overdose. Other treatments will depend on 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 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The following list includes a number of systemic adverse reactions that may be related to the use of Lipofundin® MCT/LCT. In case of accurate use of dosage, monitoring, complying with safety limits and guidelines, most of the adverse adverse reactions are very rare (

Unwanted effects are listed according to their frequency as follows:

Very rare, ADR

Blood disorders and lymphatic systems: increased blood clotting.

The immune system disorders: allergic reactions (such as anaphylaxis, skin rash, laryngeal edema, mouth and face).

Metabolic and nutrient disorders: hyperlipidemia, increased glucose - blood, metabolic acidosis, ketone -axite infection. The frequency of these adverse reactions depends on the dose and may be higher in cases of absolute or relative overdose.

Nervous system disorders: headache, drowsiness.

Vascular disorders: increase or hypotension , blush.

Respiratory, chest and medical disorders: shortness of breath, purple blue.

Gastrointestinal disorders: nausea, vomiting, anorexia.

Liver-dysfunctions: Red rash, sweating.

Muscle disorders and connective tissue: back pain , bones, chest and lumbar area.

Common disorders and condition at the place of drug use: increased body temperature, cold, cold, fat overload syndrome.

Unknown frequency

Blood disorders and lymphatic systems: leukopenia, thrombocytopenia.

Liver-dysfunctions: biliary stasis, skin and subcutaneous tissue disorders.

If a adverse reaction occurs, lipofundin® MCT/LCT or, if necessary, continue at lower doses. If you start passing down, you must monitor the patient carefully, especially at the beginning, and to determine the serum triglyceride in short time.

Information about unwanted effects

Nausea, vomiting, anorexia and glucose - blood are symptoms associated with intravenous nourishment indications and sometimes it may be related to intravenous nurturing mode.

Fat overload syndrome.

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

The cause may be genetic (differential metabolism depending on people) or fat metabolism may be affected by existing or previous diseases.

This syndrome may also appear during a serious hypergly -increasing blood triglyceride, even at the recommended transmission rate, and related to a sudden change in the patient's clinical condition, such as impaired kidney function or infection.

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

Symptoms can often be reversed if the fatty emulsion stops. If the signs of fat overload syndrome appear, lipofundin® MCT/LCT.

Warnings

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

Contraindicated

500ml lipofundin medicine 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 liver failure.

Molecularity in the liver.

Severe renal failure without kidney replacement therapy.

Acute thrombosis.

Fat vessels.

Tibbed bleeding is aggravated.

Metabolic acidosis.

Contraindicated with intravenous nurturing including:

Unstable circulatory situation is life -threatening (collapse and shock).

Unstable metabolic conditions (for example, severe after -invasive syndrome, severe blood infections, unexplained coma).

The acute phase of myocardial infarction or stroke.

Disorders of fluid and electrolytes are not adjustable, such as potassium blood and reverse dehydration.

Damage heart failure.

acute pulmonary edema.

Be cautious when used

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

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

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

It is necessary to control the electrolyte balance in serum, fluid, acid-base, cardiovascular function and-in the long-term transmission process-the number 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 transmission must be discontinued 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 by intravenous lines, it is necessary to use carbohydrates, amino acids, electrolytes, vitamins and trace elements. In addition, must ensure adequate total translation.

The ability to drive and operate machinery

No information.

Pregnancy

There is no data or limited data from the use of Lipofundin® MCT/LCT in pregnant women. Animal data is incomplete 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.

Lactation period

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

Reproduction

No data in humans. Animal studies show that there is no evidence of impact on fertility.

Drug interaction

heparin

Heparin is used in clinical doses that cause temporary liberation of lipoprotein lipase into the blood. This initially can lead to increased 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 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 carton boxes to avoid light.

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

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. After opening the first time, it must be used immediately.

Must cancel the product that has been frozen. Use when the packaging is not damaged and the inside contains emulsion in a homogeneous form and is milky white. Check the emulsion with the eye to see if there is a phase separation or not before being used.

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