Intralipid 20%

Package leaflet: Information for the user

Intralipid 20%
200 mg/ml, emulsion for infusion
Soiae oleum raffinatum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Intralipid 20% is and what it is used for
2. Important information before using Intralipid 20%
3. How to use Intralipid 20%
4. Possible side effects
5. How to store Intralipid 20%
6. Contents of the pack and other information

1. What Intralipid 20% is and what it is used for

Intralipid 20% is a fat emulsion intended for parenteral nutrition. The medicine contains refined soybean oil, which provides the body with fatty acids necessary for energy production. The medicine should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, proteins, electrolytes, vitamins, and trace elements.
The medicine is administered by intravenous infusion.

Indications:
Intralipid 20% is indicated as a source of energy and fatty acids in parenteral nutrition. It is also intended for use in patients with fatty acid deficiency in whom normal levels of these acids cannot be maintained or restored by oral administration.

2. Important information before using Intralipid 20%

When not to use Intralipid 20%
Do not use this medicine:

• if the patient is allergic to egg protein, soy, peanuts, the active substance, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is in acute shock (a syndrome of disease symptoms caused by inadequate oxygenation of vital organs);
• if the patient has severe hyperlipemia (markedly increased blood cholesterol levels);
• if the patient has severe liver failure;
• if the patient has been diagnosed with hemophagocytic syndrome (a rare, life-threatening inherited disorder characterized by high fever, enlargement of the liver and/or spleen, and a marked decrease in all blood cells).

Warnings and precautions
Intralipid 20% should be used with caution if the patient has:

• impaired fat metabolism (fat conversion);
• kidney failure;
• uncontrolled diabetes;
• pancreatitis;
• liver function disorders;
• hyperthyroidism (if accompanied by hypertriglyceridemia - markedly elevated blood triglyceride (simple fat) levels);
• sepsis (systemic inflammatory response due to infection). During treatment with Intralipid 20% in these patients, the doctor will order blood tests (measurement of triglyceride levels).

Intralipid 20% should be used with caution in newborns and premature infants with hyperbilirubinemia (markedly increased levels of the pigment causing jaundice in the blood) and in cases suspected of pulmonary hypertension (a condition in which blood pressure in the pulmonary arteries is elevated).
During prolonged administration of Intralipid 20% to newborns, especially premature infants, the doctor will order blood tests (platelet count, liver enzyme activity, and triglyceride levels).
This medicine may affect the results of certain laboratory tests. Inform the doctor about using this medicine before undergoing any tests.
Intralipid 20% may very rarely cause allergic reactions. Allergic reactions have also been observed after administration of this medicine and consumption of peanuts.
When administered to newborns and children under 2 years of age, the solution (in the bag and infusion set) must be protected from light until the end of administration. Exposure of Intralipid 20% to light, particularly after addition of trace elements and/or vitamins, may lead to the formation of peroxides and other degradation products, which can be minimized by protecting from light.

Interaction of Intralipid 20% with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking:

• insulin (a medicine used in the treatment of diabetes);
• heparin or coumarin derivatives (medicines used to reduce blood clotting).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether this medicine should be used during pregnancy or while breastfeeding.

Driving and operating machinery
Not applicable.

3. How to use Intralipid 20%

This medicine is administered exclusively by medical personnel. You must not use this medicine yourself.
If in doubt, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on age, body weight, and health condition.
Medical personnel may monitor the patient's health status during treatment.
When administering to newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration (see section 2).
Use of a higher than recommended dose of Intralipid 20%
It is unlikely that a patient will receive an excessive dose of Intralipid 20%, as this medicine is administered by trained medical personnel.
In the event of overdose, there is a risk of receiving too much fat. This may lead to a condition known as "fat overload syndrome". For detailed information, see section 4: Possible side effects. If the patient experiences the symptoms mentioned above or suspects having received a higher than recommended dose of Intralipid 20%, they should immediately inform the doctor or nurse.
Acute overdose may lead to acidosis (accumulation in the blood of excessive amounts of acidic substances or reduced concentration of alkaline substances), particularly if carbohydrates have not been co-administered.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon adverse reactions (occurring in more than 1 in 100 patients and less than 1 in 1,000 patients):

• headache;
• increased body temperature;
• tremor;
• chills;
• feeling of fatigue;
• abdominal pain;
• nausea;
• vomiting.

Very rare adverse reactions (occurring in less than 1 in 10,000 patients):

• allergic reaction (hypersensitivity), manifesting as skin rash, swelling (especially of the lips, face, eyelids, tongue, and throat), shortness of breath, or fainting. In such cases, contact a doctor immediately.
• elevated or lowered blood pressure;
• transient increase in liver enzyme activity. The doctor will inform the patient about occurrence of this adverse reaction.
• abdominal pain;
• thrombocytopenia (reduced platelet count, manifesting as petechiae, easy bruising, haematomas);
• haemolysis (breakdown of red blood cells);
• reticulocytosis (increased number of immature red blood cells);
• priapism (prolonged, painful penile erection);
• urticaria (pinkish, itchy skin blisters);
• skin rash.

Intralipid 20% may cause increased body temperature and, less frequently, tremor, chills, nausea, or vomiting (occurring in less than 1 in 100 patients).

After long-term treatment:

• thrombocytopenia has been reported in infants;
• transient increase in liver enzyme activity has been reported with or without the use of Intralipid 20%.

Fat overload syndrome
Fat overload syndrome occurs when the body has difficulty metabolizing fats due to receiving an excessive amount of Intralipid 20%. It may also occur due to a sudden change in the patient's health status (e.g. kidney problems or infection). Possible symptoms include fever, increased fat levels in the blood, cells and tissues, disturbances in the function of multiple organs, and coma. All these symptoms usually resolve after stopping the infusion.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Intralipid 20%

Keep this medicine out of the sight and reach of children.
The doctor or pharmacist is responsible for ensuring appropriate storage, use, and disposal of Intralipid 20%.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration (see section 2).

6. Contents of the package and other information

What Intralipid 20% contains

• The active substance is soybean oil. 1000 ml of emulsion contains 200 g of purified soybean oil (Soiae oleum raffinatum).
• Other ingredients (excipients) are: purified egg phospholipids, glycerol anhydrous, sodium hydroxide, water for injections.

Osmolality: 350 mOsm/kg water
pH: approximately 8
Energy value: 8.4 MJ (2000 kcal)/1000 ml
Content of organic phosphates: 15 mmol/1000 ml

What Intralipid 20% looks like and what the package contains
The medicine is a white, homogeneous emulsion.

Packaging:
Bottle
Bottles made of Type II glass with a butyl rubber stopper and an aluminium-plastic cap.
Package sizes:
100 ml in 1 bottle
250 ml in 1 bottle
500 ml in 1 bottle

Bag
The packaging consists of an inner Biofine-type bag and an outer bag.
The inner Biofine-type bag is made of plastic material.
Between the inner and outer bags there is an oxygen absorber and a bag wall damage indicator.
Package sizes:
100 ml in 1 bag
250 ml in 1 bag
500 ml in 1 bag

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer
Bottles
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Bag
Fresenius Kabi AB
S-751 74 Uppsala
Sweden

For further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89

Information intended exclusively for healthcare professionals:

Dosage and administration
The dose and rate of administration of Intralipid 20% should be adjusted according to fat clearance capacity.
See: "Fat clearance".

Dosage
1 g of triglycerides corresponds to 5 mL of Intralipid 20%.

Adult patients
The recommended maximum dose is 3 g of triglycerides/kg body weight/day. With this upper limit, Intralipid 20% may be used to meet up to 70% of energy requirements, including in patients with significantly increased energy needs.
The infusion rate of Intralipid 20% should not exceed 500 mL over 5 hours.

Newborns and infants
The recommended dose in newborns and infants is 0.5 to 4.0 g of triglycerides/kg body weight/day. The infusion rate should not exceed 0.17 g of triglycerides/kg body weight/hour (4 g/day).
Preterm infants and low-birth-weight newborns should receive Intralipid 20% starting at an initial dose of 0.5 to 1.0 g/kg body weight/day, gradually increased by 0.5 to 1.0 g/kg body weight/day up to a dose of 2 g/kg body weight/day administered as a continuous infusion over 24 hours.
Further dose increases up to 4 g/kg body weight/day may be considered only under strict monitoring of serum triglyceride concentrations, liver enzyme activity, and blood oxygen saturation.
The above administration rates are maximum rates and should not be exceeded, even to rapidly compensate for missed doses.

Administration method
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until administration is completed.

Deficiency of essential fatty acids (EFAD)
To prevent or correct essential fatty acid deficiency, 4–8% of non-protein energy should be provided as Intralipid 20%, ensuring adequate supply of linoleic and linolenic acids.
When essential fatty acid deficiency is associated with stress, the amount of drug required to correct the deficiency may be significantly increased.

Fat clearance

Adult patients
Fat clearance capacity should be closely monitored in patients under the conditions listed in section 4.4 "Special warnings and precautions for use" of the Summary of Product Characteristics, and in patients who have received Intralipid 20% for longer than one week.
Blood samples should be collected 5–6 hours after completion of the fat emulsion infusion. Blood cells should be separated from plasma by centrifugation of the blood sample. Infusion must not be continued if the plasma appears turbid or opalescent. The sensitivity of this method is insufficient to detect hypertriglyceridemia. Therefore, measurement of serum triglyceride concentration is recommended in patients suspected of impaired fat tolerance.

Newborns and infants
Fat clearance capacity should be regularly monitored in newborns and infants. The only reliable method is measurement of serum triglyceride concentration.

Overdose

Fat overload syndrome
Impaired elimination of Intralipid 20% may lead to fat overload syndrome when the drug is administered at doses exceeding recommendations.
This syndrome may also occur even at recommended infusion rates due to sudden changes in the patient's clinical condition, e.g. impaired renal function or infections. Fat overload syndrome is characterized by hyperlipidemia, fever, fat infiltration, multi-organ dysfunction, and coma. All symptoms of fat overdose generally resolve after discontinuation of Intralipid 20% infusion.
Acute fat overdose caused by administration of a triglyceride-containing fat emulsion may lead to acidosis, particularly if carbohydrates have not been co-administered.

Preparation of the medicinal product for administration
Do not use if the packaging is damaged.
Check the bag wall damage indicator (Oxalert) before removing the outer bag. If the indicator is black, oxygen has penetrated the packaging and the product must be destroyed.
The outer bag, oxygen absorber, and bag wall damage indicator should be removed after opening the outer bag.
When using the product in Biofine-type bags, see also: "Instructions for preparing the Biofine-type bag for use".

Special warnings and precautions for use
Exposure of parenteral nutrition solutions to light, particularly after addition of trace elements and/or vitamins, may have undesirable effects on clinical response in newborns due to formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, Intralipid 20% must be protected from light until administration is completed.

Pharmaceutical incompatibilities
Additional substances should be added to Intralipid 20% under aseptic conditions. Electrolyte solutions alone should not be added to Intralipid 20%. Only medicinal products, nutritional solutions, or electrolyte solutions with documented compatibility should be added. Information on compatibility with other solutions and additives, as well as on storage times of prepared mixtures, is available on request.

Storage conditions
Store below 25°C. Do not freeze.

Storage after addition of other nutritional substances
Mixing in a plastic bag (not containing phthalates): mixtures prepared under aseptic and validated conditions should be used within 7 days of preparation. The nutritional mixture bag may be stored for no more than 6 days in a refrigerator at 2 to 8°C, followed by infusion within 24 hours.

Disposal of unused medicinal product
Any unused residues or waste of the medicinal product should be disposed of in accordance with local regulations.

Special precautions for disposal and preparation of the medicinal product for administration
When used in newborns and children under 2 years of age, protect from light until administration is completed. Exposure of Intralipid 20% to light, particularly after addition of trace elements and/or vitamins, leads to formation of peroxides and other degradation products, which can be minimized by providing protection from light.

Instructions for preparing the Biofine-type bag for use
((included only with Biofine-type bags))

The bag wall damage indicator (Oxalert) A should be checked before removing the outer bag. If the indicator is black, the outer bag is damaged and the product must be destroyed.

Remove the outer bag by tearing the seal at the top and pulling along the package. The bag wall damage indicator A and the oxygen absorber B should be removed.

If adding additional substances, remove the single-use closure plug marked with an arrow, protecting the white port for administration of these substances.
If no additional substances are added – proceed to point 5.

Insert the needle and administer additional substances (with documented compatibility) through the center of the injection site. Use syringes with needles 18 to 23 G in diameter and maximum length of 40 mm.

Use an infusion device without an air vent or close the air inlet if the device has one. Follow the infusion device user manual. Use an infusion device with a diameter specified in ISO 8536-4 standard, 5.6 ± 0.1 mm.

Remove the single-use closure plug protecting the blue infusion port.

Hold the base of the infusion port. Insert the infusion device spike into the infusion port and gently screw it in until fully inserted.

Hang the bag using the designated hole and start the infusion.