LIPOFUNDIN 5 G + 5 G/100 ML Emulsion for intravenous infusion
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Інструкція із застосування LIPOFUNDIN MKT
Зміст інструкції
- LIPOFUNDIN MCT 5g + 5g/100ml emulsion for infusion
- LIPOFUNDIN MCT 10g + 10g/100ml emulsion for infusion
LIPOFUNDIN MCT 5g + 5g/100ml emulsion for infusion
Soybean oil, refined; medium chain triglycerides
Read this leaflet carefully before using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What LIPOFUNDIN MCT is and what it is used for
- 2. What you need to know before using LIPOFUNDIN MCT
- 3. How to use LIPOFUNDIN MCT
- 4. Possible side effects
- 5. How to store LIPOFUNDIN MCT
- 6. Contents of the pack and other information
1. What is LIPOFUNDIN MCT and what is it used for
LIPOFUNDIN MCT is an oil-in-water emulsion. The oils contained in LIPOFUNDIN MCT
provide energy and contain essential fatty acids that the body needs.
LIPOFUNDIN MCT is administered intravenously (into a vein) as part of a regimen of
artificial nutrition because you are unable to feed adequately or cannot be fed
with a probe .
2. What you need to know before you use LIPOFUNDIN MCT
Do not use LIPOFUNDIN MCT
- if you are allergic to egg or soy proteins, soy or peanut products, or any of the other ingredients of this medicine (listed in section 6)
Do not use LIPOFUNDIN MCT if you suffer from any of the following conditions:
- severe increase in blood fat levels (severe hyperlipidemia)
- if you have a disease that causes the blood not to clot properly (severe coagulopathy)
- severe liver failure (severe hepatic insufficiency)
- bile flow disorders (intrahepatic cholestasis)
- blockage of a blood vessel by blood clots or fat (acute thromboembolic events, fat embolism)
- constitutional predisposition to bleeding (aggravating hemorrhagic diathesis)
- conditions of excessive acid in the blood (metabolic acidosis)
- potentially fatal circulatory disorders, such as those that may occur in the event of collapse or shock
- in case of unstable metabolism, for example due to severe trauma or surgery (post-aggressive syndrome), widespread infections (severe sepsis) or coma of unknown origin
- heart attack (myocardial infarction) or acute stroke
- severe kidney failure (severe renal insufficiency) without dialysis
- untreated disorders of fluid, salt (electrolytes) or acid-base balance, for example low fluid and salt content in the body (hypotonic dehydration) or low levels of
potassium in the blood (hypokalemia), or increased fluid in the body (see “Warnings and
precautions)
- severe heart failure (decompensated heart failure)
- fluid accumulation in the lungs (acute pulmonary edema)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using LIPOFUNDIN MCT.
During the infusion, the doctor must regularly check the amount of fat in the blood (serum triglycerides). If blood fat levels rise excessively, the doctor may reduce the infusion rate or stop the infusion.
Before this medicine is administered to you, the doctor must correct any disturbances in
fluid and salt content in the body and acid-base balance.
While this solution is being administered to you, the doctor must monitor body weight, fluid and salt levels in the blood, acid-base balance, and heart function. The doctor may deem
it necessary to administer this solution for several weeks. In this case, liver function and
blood coagulation must be monitored and a blood cell count must be performed.
Allergic reactions to this medicine are extremely rare. If you show signs of an allergic
reaction, such as fever, tremors, skin rash, or breathing problems, during the administration
of this medicine, the doctor must immediately stop the infusion.
In addition to LIPOFUNDIN MCT, you may receive carbohydrate and amino acid solutions to prevent
a metabolic condition in which the amount of acid in the blood increases (metabolic acidosis).
To complete the parenteral nutrition, you may also receive carbohydrate and amino acid solutions, fluids, electrolytes, vitamins and trace elements.
Mixing with incompatible substances can cause degradation of the emulsion or
precipitation of particles, both of which pose a high risk of embolism.
Elderly patients
In some situations, the ability to properly utilize fats may be impaired. The doctor
will bear in mind that some of these conditions are often associated with advanced age, for example
impaired heart or kidney function.
Patients with impaired lipid metabolism
In some situations, the ability to properly utilize fats may be impaired. It is therefore
important that the doctor is informed:
- if you suffer from diabetes mellitus
- if you suffer from inflammation of the pancreas (pancreatitis)
- if you have impaired liver or kidney function (renal insufficiency, impaired hepatic function)
- if you suffer from blood poisoning (sepsis)
- if you suffer from reduced thyroid activity (hypothyroidism)
- if you suffer from certain lung diseases If your ability to properly utilize fats is impaired, the doctor must carefully monitor blood fat levels (serum triglycerides).
Children
In infants at risk of jaundice, the doctor must monitor fat levels (serum triglycerides) and
bilirubin in the blood. The doctor may need to adjust the daily fat dose or
the rate at which they are administered.
During the infusion, this solution must be protected from light from any phototherapy, in
order to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).
When used in premature infants and children up to 2 years of age, after preparation for
infusion, the emulsion (including administration sets) must be protected from exposure to
light until the administration is completed. Exposure of parenteral nutrition mixtures containing LIPOFUNDIN MCT to light, especially after the addition of trace elements and/or
vitamins, generates peroxides and other degradation products that can be reduced by protection
from light exposure.
Other medicines and LIPOFUNDIN MCT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
LIPOFUNDIN MCT can interact with other medicines. Tell your doctor if you are taking or receiving
certain medicines to control blood clotting, namely:
- heparin
- coumarin products, for example warfarin
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
No data are available regarding the use of LIPOFUNDIN MCT in pregnant women.
If you are pregnant, you will only receive this medicine if your doctor considers it essential for your
recovery. Breastfeeding is not recommended for mothers undergoing parenteral nutrition.
Driving and operating machinery
Generally, LIPOFUNDIN MCT is administered to immobilized patients in a controlled
environment (hospital or clinic). LIPOFUNDIN MCT does not impair the ability to drive vehicles and operate machinery
Important information about some of the excipients of LIPOFUNDIN MCT
This medicine contains less than 1 mmol of sodium (23 mg) per litre, that is to say it is practically “sodium-free”.
3. How to use LIPOFUNDIN MCT
This medicine is administered intravenously (into a vein).
The doctor will decide the dose that will be administered to you and the duration of treatment based on your
needs.
When used in premature infants and children up to 2 years of age, after preparation for
infusion, the emulsion (including the administration sets) must be protected from exposure to
light until the administration is completed (see section 2).
If you receive more LIPOFUNDIN MCT than you should
If you have received an excessive amount of LIPOFUNDIN MCT, you may have elevated
levels of fats in the blood (hyperlipidemia), an increase in the amount of acids (metabolic acidosis), or you may
suffer from the so-called "fat overload syndrome".
For the symptoms of fat overload syndrome see section 4 “Possible undesirable effects”
If you have received an excessive amount of LIPOFUNDIN MCT, the infusion will be stopped. The infusion
will not be resumed until you have recovered. The doctor may possibly modify the daily dose
of fats. The doctor will decide on any additional treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be serious. If you get any of these side effects, tell your doctor immediately, who will stop giving you this medicine:
Very rare (may affect up to 1 in 10,000 people)
- allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, tongue and throat, difficulty breathing
- breathing problems (dyspnoea)
- bluish skin (cyanosis)
Other side effects
Very rare (may affect up to 1 in 10,000)
- fat overload syndrome (see below for fat overload syndrome)
- increased tendency of the blood to clot (hypercoagulability)
- excessively high levels of fats in the blood (hyperlipidemia); see below for fat overload syndrome
- excessively high levels of sugar in the blood (hyperglycaemia)
- metabolic conditions in which the amount of acid in the blood increases (metabolic acidosis, ketoacidosis)
- decrease or increase in blood pressure
- drowsiness
- nausea, vomiting, loss of appetite
- headache
- hot flushes
- redness of the skin (erythema)
- high body temperature
- sweating
- feeling of cold, chills
- pain in the back, bones, chest and lower back
Not known (frequency cannot be estimated from available data)
- impaired bile flow (cholestasis)
- decrease in the number of white blood cells (leucopenia)
- decrease in the number of platelets (thrombocytopenia)
Fat overload syndrome
You may develop “fat overload syndrome” if you receive an excessive amount of LIPOFUNDIN MCT or if your body has problems using fats. Your body’s ability to use fats may be affected by a sudden change in your condition (such as due to kidney problems or an infection). The symptoms are generally reversible if the infusion is stopped. Fat overload syndrome is characterised by the following symptoms:
- high levels of fats in the blood (hyperlipidemia)
- fever
- deposition of fat in the liver or other organs (lipid infiltration)
- enlargement of the liver (hepatomegaly), sometimes accompanied by jaundice
- enlargement of the spleen (splenomegaly)
- decrease in the number of red blood cells in the blood (anaemia)
- decrease in the number of white blood cells in the blood (leucopenia)
- decrease in the number of platelets in the blood (thrombocytopenia)
- disorders of the blood’s ability to clot
- breakdown of red blood cells (haemolysis)
- increase in immature red blood cells (reticulocytosis)
- abnormalities in tests measuring liver function
- loss of consciousness In the event of adverse reactions, the infusion of LIPOFUNDIN MCT must be stopped or, if necessary, continued at a reduced dose.
Reporting of side effects
If any side effects get worse, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store LIPOFUNDIN MCT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze. Products that have been frozen
must be discarded.
Keep the vials in the outer packaging to protect the medicine from light.
Use only if the vial is intact and if the medicine is homogeneous and milky white, without visible oil
droplets.
The vials are for single use only. After infusion, any remaining emulsion and the
container must be discarded.
When used in premature infants and children up to the age of 2 years, after preparation for
infusion the emulsion (including the administration sets) must be protected from exposure to
light until the administration is completed (see section 2).
6. Package Contents and Other Information
What LIPOFUNDIN MCT contains
The active ingredients in 1000 ml of LIPOFUNDIN MCT are:
Refined soybean oil 50.0 g
Medium-chain triglycerides (MCT) 50.0 g
Essential fatty acid content:
linoleic acid 24.0 – 29.0 g/l
α-linolenic acid 2.5 – 5.5 g/l
Energy value [kJ/l (kcal/l)] 4330 (1035)
Theoretical osmolarity [mOsm/l] 345
Acidity or alkalinity (titration at pH 7.4) [mmol/l] <0.5
pH 6.0-8.8
The other components are glycerol, egg phospholipids for injection, -tocopherol, sodium oleate and water
for injectable preparations.
Description of the appearance of LIPOFUNDIN MCT and package contents
LIPOFUNDIN MCT is a milky white emulsion. It is an emulsion for infusion, meaning it is
administered through a tube inserted into a vein.
It is supplied in glass bottles closed with rubber stoppers and containing:
- 100 ml, available in packs of 10 x 100 ml
- 250 ml, available in packs of 10 x 250 ml
- 500 ml, available in packs of 10 x 500 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
- B. Braun Melsungen AG Carl-Braun-Straße 1 Postal address34212 Melsungen, Germany 34209 Melsungen, Germany Telephone: +49-5661-71-0 Fax: +49-5661-71-4567
The following information is intended exclusively for doctors or healthcare professionals:
Other special warnings and precautions for use
Mixing with incompatible substances can cause degradation of the emulsion or
precipitation of particles, both of which carry a high risk of embolism.
In solutions with higher lipid concentrations (e.g. LIPOFUNDIN MCT 10g + 10g/100ml),
the ratio between emulsifier (phospholipid) and oil is lower compared to less
concentrated lipid emulsions. This ensures a favourably lower plasma concentration of triglycerides,
phospholipids, free fatty acids and pathological lipoprotein X in the patients' blood. More
concentrated lipid emulsions, such as LIPOFUNDIN MCT 10g + 10g/100ml, are therefore to be preferred to
less concentrated lipid emulsions.
Exposure of mixtures for parenteral nutrition to light, especially after
the addition of trace elements and/or vitamins, can have adverse effects on clinical outcome in neonates, due to
the generation of peroxides and other degradation products. When used in premature infants and
children up to the age of 2 years, after preparation for infusion LIPOFUNDIN MCT must be
protected from light until the administration is complete.
Interference with laboratory tests
Lipids can interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase,
oxygen saturation) if the blood sample is taken before the lipids have been eliminated from
the bloodstream, which can take 4-6 hours.
Incompatibilities
LIPOFUNDIN MCT must not be used as a vehicle solution for electrolyte concentrates
or other medicinal products and the emulsion must not be mixed with other infusion solutions in an
uncontrolled manner, as this may no longer guarantee adequate emulsion stability.
Special precautions for disposal and handling
Shake gently before use.
Before infusion, the emulsion must be brought to room temperature without the medicinal
product being placed in a heating device (oven or microwave).
If filters are used, these must be lipid-permeable.
Before the infusion of a lipid emulsion with other solutions via a Y-connector or bypass set
the compatibility of these solutions must be verified, especially in the case of concomitant administration
of carrier solutions to which medicinal products have been added. Particular caution is required
in the case of co-infusion of solutions containing divalent electrolytes (such as calcium or magnesium).
When using a product packaged in flexible bags, the vent of the administration set must
be closed.
When used in premature infants and children up to the age of 2 years, after preparation for
infusion, protect mixtures containing LIPOFUNDIN MCT from exposure to light until
administration is complete. Exposure of such mixtures to light, especially after
the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can
be reduced by protecting them from exposure to light.
Dosage and method of administration
Adults
The recommended dose is 0.7 – 1.5 g /kg of body weight per day.
The maximum daily dose is 2.0 g /kg of body weight.
In the case of long-term home treatment (> 6 months) or short bowel syndrome, the maximum daily dose is 1.0 g/kg of body weight per day.
Children
In children, the daily dose of lipids should be infused continuously for approximately 24 hours.
When used in premature infants and children up to the age of 2 years, after preparation for
infusion, the emulsion (including the administration sets) must be protected from exposure to
light until the administration is complete.
Maximum daily dose
| Population | Maximum daily dose | |
| Premature infants | 4.0 g/kg/day | 40 mL/kg/day |
| and Children up to 8 years of age | 3.0 g/kg/day | 30 mL/kg/day |
| Adults and children from 8 years of age | 2.0 g/kg/day | 20 mL/kg/day |
| Long-term home parenteral nutrition a (> 6 months) | 1.0 g/kg/day | 10 mL/kg/day |
Infusion rate
The infusion rate should be as slow as possible. The infusion rate used during the
first 15 minutes of infusion should be only 50% of the maximum infusion rate.
The patient must be constantly monitored in case adverse reactions occur.
Maximum infusion rate
| Population | Maximum infusion rate | |
| Premature infants | 0.17 g/kg/h | 1.7 mL/kg/h |
| Children up to 8 years of age | 0.13 g/kg/h | 1.3 mL/kg/h |
| Adults and children from 8 years of age | 0.15 g/kg/h | 1.5 mL/kg/h |
Method of administration
Intravenous infusion.
Fat emulsions can be administered via peripheral vein and by total parenteral nutrition in the peripheral vein.
The Y-connector or bypass should be positioned as close as possible to the patient if lipid emulsions are administered with amino acid and carbohydrate solutions.
The duration of administration of LIPOFUNDIN MCT 5g + 5g/100ml as part of a total parenteral nutrition is generally 1-2 weeks. If parenteral nutrition with
lipid emulsions is also indicated, LIPOFUNDIN MCT 5g + 5g/100ml can be administered for much longer periods, provided adequate monitoring is carried out.
LIPOFUNDIN MCT 10g + 10g/100ml emulsion for infusion
Soybean oil, refined; medium chain triglycerides
Read this leaflet carefully before you start to use this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What LIPOFUNDIN MCT is and what it is used for.
- 2. What you need to know before you use LIPOFUNDIN MCT.
- 3. How to use LIPOFUNDIN MCT.
- 4. Possible side effects.
- 5. How to store LIPOFUNDIN MCT.
- 6. Contents of the pack and other information.
1. What is LIPOFUNDIN MCT and what is it used for
LIPOFUNDIN MCT is an oil-in-water emulsion. The oils contained in LIPOFUNDIN MCT
provide energy and contain essential fatty acids that the body needs.
LIPOFUNDIN MCT is administered to you intravenously (into a vein) as part of a regimen of
artificial nutrition because you are unable to feed adequately or cannot be fed
with a tube .
2. What you need to know before you use LIPOFUNDIN MCT
Do not use LIPOFUNDIN MCT
- if you are allergic to egg or soy proteins, soy or peanut products, or any of the other ingredients of this medicine (listed in section 6)
Do not use LIPOFUNDIN MCT if you suffer from any of the following conditions:
- severe increase in blood fat levels (severe hyperlipidemia)
- if you have a condition in which the blood does not clot as it should (severe coagulopathy)
- severe liver failure (severe hepatic insufficiency)
- bile flow disorders (intrahepatic cholestasis)
- blockage of a blood vessel by blood clots or fat (acute thromboembolic events, fat embolism)
- a constitutional predisposition to bleeding (aggravating hemorrhagic diathesis)
- conditions of excessive acid in the blood (metabolic acidosis)
- potentially life-threatening circulatory disorders, such as those that can occur in the event of collapse or shock
- in case of unstable metabolism, e.g. due to severe trauma or surgery (post-aggressive syndrome), widespread infections (severe sepsis) or coma of unknown origin
- heart attack (myocardial infarction) or acute stroke
- severe kidney failure (severe renal insufficiency) without dialysis
- untreated disorders of fluid or salt balance (electrolytes), or acid-base balance, for example low water and salt content in the body (hypotonic dehydration) or low levels of
potassium in the blood (hypokalemia), or increased fluid in the body (see “Warnings and
precautions”)
- severe heart failure (decompensated heart failure)
- fluid accumulation in the lungs (acute pulmonary edema)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using LIPOFUNDIN MCT.
During the infusion, the doctor must regularly check the amount of fat in the blood (serum triglycerides). If blood fat levels rise excessively, the doctor may reduce the infusion rate or stop the infusion.
Before you are given this medicine, the doctor must correct any disturbances in
fluid and salt content in the body and acid-base balance.
While you are being given this solution, the doctor must monitor body weight, fluid levels, blood salts and acid-base balance as well as cardiac function. The doctor may consider
it necessary to give you this solution for several weeks. In this case, liver function and
blood coagulation must be monitored and a blood cell count must be performed.
Allergic reactions to this medicine are extremely rare. If you show signs of an allergic
reaction, such as fever, tremor, skin rash or breathing problems, during administration
of this medicine, the doctor must immediately stop the infusion.
In addition to LIPOFUNDIN MCT, you may receive carbohydrate and amino acid solutions to prevent
a metabolic condition in which the amount of acid increases in the blood (metabolic acidosis).
To complete parenteral nutrition, you may also receive carbohydrate and amino acid solutions, fluids, electrolytes, vitamins and trace elements.
Mixing with incompatible substances can cause degradation of the emulsion or
precipitation of particles, both of which pose a high risk of embolism.
Elderly patients
In some situations, the ability to use fats correctly may be impaired. The doctor
will bear in mind that some of these conditions are often associated with advanced age, for example the
impairment of heart or kidney function.
Patients with impaired lipid metabolism
In some situations, the ability to use fats correctly may be impaired. It is therefore
important that the doctor is informed:
- if you suffer from diabetes mellitus
- if you suffer from inflammation of the pancreas (pancreatitis)
- if you have impaired liver or kidney function (renal insufficiency, impaired liver function)
- if you suffer from blood poisoning (sepsis)
- if you suffer from reduced thyroid activity (hypothyroidism)
- if you suffer from certain lung diseases If your ability to use fats correctly is impaired, the doctor must carefully monitor blood fat levels (serum triglycerides).
Children
In infants at risk of jaundice, the doctor must monitor fat (serum triglycerides) and
bilirubin levels in the blood. The doctor may need to adjust the daily fat dose or
the rate at which they are administered.
During the infusion, this solution must be protected from the light of any phototherapy, in
order to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).
When used in premature infants and children up to the age of 2 years, after preparation for
infusion the emulsion (including administration sets) must be protected from exposure to
light until the administration is complete. Exposure of parenteral nutrition mixtures containing LIPOFUNDIN MCT to light, especially after the addition of trace elements and/or
vitamins, generates peroxides and other degradation products that can be reduced by protection
from light exposure.
Other medicines and LIPOFUNDIN MCT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
LIPOFUNDIN MCT can interact with other medicines. Tell your doctor if you are taking or receiving
certain medicines to control blood clotting, namely:
- heparin
- coumarin products, e.g. warfarin
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
No data are available regarding the use of LIPOFUNDIN MCT in pregnant women.
If you are pregnant, you will receive this medicine only if the doctor considers it essential for your
recovery. Breastfeeding is not recommended for mothers undergoing parenteral nutrition.
Driving and operating machinery
Generally, LIPOFUNDIN MCT is administered to immobile patients in a controlled environment
(hospital or clinic). LIPOFUNDIN MCT does not impair the ability to drive vehicles and operate
machinery.
Important information about some of the excipients of LIPOFUNDIN MCT
This medicine contains less than 1 mmol of sodium (23 mg) per litre, i.e. it is practically “sodium-free”.
3. How to use LIPOFUNDIN MCT
This medicine is administered intravenously (into a vein).
The doctor will decide the dose that will be administered to you and the duration of treatment based on your
needs.
When used in premature infants and children up to 2 years of age, after preparation for
infusion, the emulsion (including the administration sets) must be protected from exposure to
light until the administration is complete (see section 2).
If you receive more LIPOFUNDIN MCT than you should
If you have received an excessive amount of LIPOFUNDIN MCT, you may have elevated
levels of fats in the blood (hyperlipidemia), an increase in the amount of acids (metabolic acidosis), or you may
suffer from the so-called "fat overload syndrome".
For the symptoms of fat overload syndrome see section 4 “Possible undesirable effects”
If you have received an excessive amount of LIPOFUNDIN MCT, the infusion will be stopped. The infusion
will not be resumed until you have recovered. The doctor may eventually modify the daily dose
of fats. The doctor will decide on any additional treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medicine:
Very rare (may affect up to 1 in 10,000 people)
- allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, tongue and throat, difficulty breathing
- breathing problems (dyspnea)
- bluish skin (cyanosis) Other side effectsVery rare (may affect up to 1 in 10,000 people)
- fat overload syndrome (see “Fat Overload Syndrome” below)
- increased tendency of the blood to clot (hypercoagulability)
- excessively high levels of fats in the blood (hyperlipidemia); for fat overload syndrome see below
- excessively high levels of sugar in the blood (hyperglycemia)
- metabolic conditions in which the amount of acid in the blood increases (metabolic acidosis, ketoacidosis)
- reduction or increase in blood pressure
- drowsiness
- nausea, vomiting, loss of appetite
- headache
- hot flashes
- redness of the skin (erythema)
- high body temperature
- sweating
- feeling of cold, chills
- pain in the back, bones, chest and lower back Not known (frequency cannot be estimated from available data)
- reduction in the number of white blood cells (leukopenia)
- reduction in the number of platelets (thrombocytopenia)
Fat Overload Syndrome
You may suffer from a “fat overload syndrome” if you have received an excessive amount of LIPOFUNDIN MCT or if your body has problems using fats. Your body’s ability to use fats may be affected by a sudden change in your condition (such as due to kidney problems or an infection). The symptoms are generally reversible if the infusion is stopped. Fat overload syndrome is characterized by the following symptoms:
- high levels of fats in the blood (hyperlipidemia)
- fever
- deposition of fats in the liver or other organs (lipid infiltration)
- enlargement of the liver (hepatomegaly), sometimes accompanied by jaundice
- enlargement of the spleen (splenomegaly)
- reduction in the number of red blood cells in the blood (anemia)
- reduction in the number of white blood cells in the blood (leukopenia)
- reduction in the number of platelets in the blood (thrombocytopenia)
- disorders of the blood's ability to clot
- breakdown of blood cells (hemolysis)
- increase in immature red blood cells (reticulocytosis)
- abnormalities in tests measuring liver function
- loss of consciousness In the event of adverse reactions, the infusion of LIPOFUNDIN MCT must be stopped or, if necessary, continued at a reduced dosage. Reporting of side effects
If any of the side effects worsen, or if you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store LIPOFUNDIN MCT 10g + 10g/100ml
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze. Products that have been frozen
must be discarded.
Keep the vials in the outer packaging to protect the medicine from light.
Use only if the vial is intact and if the medicine is homogeneous and milky white, without visible oil
droplets.
The vials are for single use only. After infusion, any remaining emulsion and the
container must be discarded.
When used in premature infants and children up to 2 years of age, after preparation for
infusion the emulsion (including the administration sets) must be protected from exposure to
light until the administration is complete (see section 2).
6. Package Contents and Other Information
What LIPOFUNDIN MCT contains
The active ingredients in 1,000 ml of LIPOFUNDIN MCT are:
Soybean oil, refined 100.0 g
Medium-chain triglycerides (MCT) 100.0 g
Essential fatty acid content
Linoleic acid 48.0 – 58.0 g/l
α-linolenic acid 5.0 – 11.0 g/l
Energy value [kJ/l (kcal/l)] 8095 (1935)
Theoretical osmolarity [mOsm/l] 380
Acidity or alkalinity (titration at pH 7.4) [mmol/l] < 0.5
pH 6.0-8.5
The other components are glycerol, egg phospholipids for injection, -tocopherol, sodium oleate and water
for injectable preparations.
Description of the appearance of LIPOFUNDIN MCT and package contents
LIPOFUNDIN MCT is a milky white emulsion. It is an emulsion for infusion, meaning it is
administered through a tube inserted into a vein.
It is supplied in glass bottles closed with rubber stoppers and containing:
- 100 ml, available in packs of 10 x 100 ml
- 250 ml, available in packs of 10 x 250 ml
- 500 ml, available in packs of 10 x 500 ml
- 1,000 ml, available in packs of 6 x 1,000 ml Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
- B. Braun Melsungen AG Carl-Braun-Straße 1 Postal address34212 Melsungen, Germany 34209 Melsungen, Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-4567
The following information is intended exclusively for doctors or healthcare professionals:
Further warnings and special precautions for use
Mixing with incompatible substances can cause degradation of the emulsion or
precipitation of particles, both of which carry a high risk of embolism.
In solutions with higher lipid concentrations (e.g. LIPOFUNDIN MCT 10g + 10g/100ml),
the ratio between emulsifier (phospholipid) and oil is lower compared to less
concentrated lipid emulsions. This ensures a favourably lower plasma concentration of triglycerides,
phospholipids, free fatty acids and pathological lipoprotein X in the patients' blood. More
concentrated lipid emulsions, such as LIPOFUNDIN MCT 10g + 10g/100ml, are therefore to be preferred to
less concentrated lipid emulsions.
Exposure of parenteral nutrition mixtures to light, especially after
the addition of trace elements and/or vitamins, can have adverse effects on clinical outcome in neonates, due to
the generation of peroxides and other degradation products. When used in preterm infants and
children up to the age of 2 years, after preparation for infusion LIPOFUNDIN MCT must be
protected from ambient light until the administration is complete.
Interference with laboratory tests
Lipids can interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase,
oxygen saturation) if the blood sample is taken before the lipids have been eliminated from the
bloodstream, which can take 4-6 hours.
Incompatibilities
LIPOFUNDIN MCT must not be used as a carrier solution for electrolyte concentrates
or other medicines, and the emulsion must not be mixed with other infusion solutions in an uncontrolled manner, because in such cases adequate stability of the emulsion can no longer be guaranteed.
Special precautions for disposal and handling
Shake gently before use.
Before infusion, the emulsion must be brought to room temperature without the medicine
being placed in a heating device (oven or microwave).
If filters are used, these must be lipid-permeable.
Before infusion of a lipid emulsion with other solutions via a Y-connector or bypass set
the compatibility of these solutions must be checked, especially in the case of concomitant administration
of carrier solutions to which medicines have been added. Particular caution is required
in the case of co-infusion of solutions containing divalent electrolytes (such as calcium or magnesium).
When using a product packaged in flexible bags, the vent of the administration set must
be closed.
When used in preterm infants and children up to the age of 2 years, after preparation for
infusion, protect mixtures containing LIPOFUNDIN MCT from exposure to light until
administration is complete. Exposure of such mixtures to light, especially after
the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can
be reduced by protecting them from exposure to light.
Dosage and Administration
Adults
The recommended dose is 0.7 – 1.5 g/kg of body weight per day.
The maximum daily dose is 2.0 g/kg of body weight.
In case of long-term home treatment (> 6 months) or short bowel syndrome, the maximum daily dose is 1.0 g/kg of body weight per day.
Children
In children, the daily dose of lipids should be infused continuously for approximately 24 hours.
When used in preterm infants and children up to the age of 2 years, after preparation for
infusion, the emulsion (including the administration sets) must be protected from exposure to
light until the administration is complete.
Maximum daily dose
| Population | Maximum daily dose | |
| Preterm infants | F 4.0 g/kg/day | 40 mL/kg/day |
| Children up to 8 years of age | 3.0 g/kg/day | 30 mL/kg/day |
| Adults and children from 8 years of age | l 2.0 g/kg/day | 20 mL/kg/day |
| e d Long-term home parenteral nutrition (> 6 months) | 1.0 g/kg/day | 10 mL/kg/day |
Infusion rate
The infusion rate must be as slow as possible. The infusion rate used during the
first 15 minutes of infusion must be only 50% of the maximum infusion rate.
The patient must be constantly monitored in case adverse reactions occur.
Maximum infusion rate
| l Population | Maximum infusion rate | |
| a Preterm infants | 0.17 g/kg/h | 1.7 mL/kg/h |
| t I Children up to 8 years of age | 0.13 g/kg/h | 1.3 mL/kg/h |
| Adults and children from 8 years of age | 0.15 g/kg/h | 1.5 mL/kg/h |
Method of administration
Intravenous infusion.
Fat emulsions can be administered via peripheral vein and by total parenteral nutrition in a peripheral vein.
The Y-connector or bypass must be positioned as close as possible to the patient if lipid emulsions are administered with amino acid and carbohydrate solutions.
The duration of administration of LIPOFUNDIN MCT as part of total parenteral nutrition is
generally 1-2 weeks. If parenteral nutrition with lipid emulsions is also indicated, LIPOFUNDIN MCT can be administered for much longer periods, provided adequate monitoring is carried out.
Не впевнені, чи підходить вам цей лікарський засіб?
Обговоріть симптоми та можливі варіанти лікування з лікарем онлайн.
Виникли питання під час прийому ліків?
Обговоріть свої симптоми та лікування з лікарем онлайн.
- Країна реєстрації
- Лікарська формаEmulsion for intravenous infusion, 5 G + 5 G/100 ML
- Код АТХB05BA02
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до LIPOFUNDIN MKTЛікарська форма: Emulsion for intravenous infusion, 20 %Діюча речовина: fat emulsionsВиробник: BAXTER S.P.A.Потрібен рецептЛікарська форма: Emulsion for intravenous infusion, 200 MG/MLДіюча речовина: fat emulsionsВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Emulsion for intravenous infusion, 50 MLДіюча речовина: fat emulsionsВиробник: FRESENIUS KABI DEUTSCHLAND GMBHПотрібен рецепт
Аналоги LIPOFUNDIN MKT в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LIPOFUNDIN MKT у Польща
Аналог LIPOFUNDIN MKT у Україна
Аналог LIPOFUNDIN MKT у Іспанія
Лікарі онлайн щодо LIPOFUNDIN MKT
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на LIPOFUNDIN MKT онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LIPOFUNDIN MKT потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у LIPOFUNDIN MKT — fat emulsions. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
LIPOFUNDIN MKT виробляється компанією B. BRAUN MELSUNGEN AG. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування LIPOFUNDIN MKT з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати LIPOFUNDIN MKT у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (fat emulsions) включають KLINOLEIK, LIPIDEM, OMEGAVEN. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
