Patient Information

INTRALIPID 200 mg/ml Infusion Emulsion

Purified Soybean Oil

In this leaflet:

1. What INTRALIPID 200 mg/ml is and what it is used for
2. Before using INTRALIPID 200 mg/ml
3. How to use INTRALIPID 200 mg/ml
4. Possible side effects
5. Storage of INTRALIPID 200 mg/ml
6. Additional information for healthcare professionals

INTRALIPID 200 mg/ml is a lipid emulsion for intravenous infusion. It is presented in plastic bags with an outer bag of 100 ml, 250 ml, and 500 ml. It belongs to the group of medications called intravenous solutions for parenteral nutrition.

INTRALIPID is indicated for patients who require intravenous nutrition for the provision of energy and essential fatty acids. INTRALIPID is also indicated for patients with essential fatty acid deficiency (EFAD) who cannot maintain or restore a normal pattern of essential fatty acids through oral intake.

No use INTRALIPID 200 mg/ml:

INTRALIPID is contraindicated in patients with acute shock and in patients with severe hyperlipemia. Severe liver insufficiency. Hemophagocytic syndrome.

Hypersensitivity (allergy) to egg protein, soy, or peanut or to any of the active principles or excipients.

Tenga especial cuidado con INTRALIPID 200 mg/ml:

INTRALIPID should be administered with caution in cases of lipid metabolism alterations such as renal insufficiency, in uncompensated diabetes mellitus, pancreatitis, liver function alteration, hypothyroidism (if there is hypertriglyceridemia) and sepsis. If INTRALIPID is administered to patients in these situations, it is mandatory to perform a strict control of the serum triglyceride concentration.

This product contains soy oil and egg phospholipids, which very rarely may cause allergic reactions. Cross-reactions between soy and peanut have been observed.

INTRALIPID should be administered with caution to neonates and premature infants with hyperbilirubinemia and in cases of possible pulmonary hypertension. In neonates, and particularly in premature infants, with long-term parenteral nutrition, the platelet count, liver function test, and serum triglyceride concentration should be monitored.

INTRALIPID may interfere with certain laboratory determinations (bilirubin, lactate dehydrogenase, oxygen saturation, Hb, etc), if the blood sample is taken before the lipids have been adequately eliminated from the bloodstream. Lipids are eliminated after a lipid-free period of 5-6 hours, in most patients.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from exposure to light until the end of administration. Exposure of INTRALIPID to ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from exposure to light.

Uso de otros medicamentos:

Some medications such as insulin may interfere with the body's lipase system. However, this type of interaction has only minor clinical importance.

Heparin, at therapeutic doses, produces a transient increase in plasma lipolysis, leading to a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.

Soy oil contains vitamin K1, which should be taken into account in patients undergoing treatment with coumarin derivatives, as these interfere with vitamin K1.

This medication should not be mixed with other products unless compatibility data are available.

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those acquired without a prescription.

Embarazo y lactancia:

Consult your doctor or pharmacist before using any medication.

No adverse effects have been reported during pregnancy and lactation.

Conducción y uso de máquinas:

No effects are expected on the ability to drive and use machinery.

Follow exactly the administration instructions for Intralipid 200 mg/ml as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Due to the risk of microbiological contamination, an open container must be infused within a maximum of 24 hours.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration (see section 2).

Dosage and method of administration

The ability to eliminate INTRALIPID must determine the dosage and infusion rate. See later,Elimination of lipids.

DOSAGE

1 g of triglycerides corresponds to 5 ml of INTRALIPID 200 mg/ml.

Adults.The maximum recommended dose is 3 g of triglycerides/kg body weight/day. Administering this upper limit, INTRALIPID provides 70% of the energy requirements, even in patients with highly increased energy requirements. The infusion rate for INTRALIPID must not exceed 500 ml in 5 hours.

Newborns and children.The recommended dose range in newborns and children is 0.5-4 g of triglycerides/kg body weight/day. The infusion rate must not exceed 0.17 g of triglycerides/kg body weight/hour (4 g in 24 hours). In premature and low-birth-weight newborns, INTRALIPID should be infused preferably continuously for 24 hours. The initial dose should be 0.5-1 g/kg body weight/day followed by a successive increase of 0.5-1 g/kg body weight/day to 2 g/kg body weight/day. The dose can be increased to 4 g/kg body weight/day only under close monitoring of serum triglyceride levels, liver function tests, and oxygen saturation. The indicated rates are the maximum rates and must not be exceeded to compensate for undosed amounts.

Essential fatty acid deficiency (EFAD).To prevent or correct an essential fatty acid deficiency, 4-8% of non-protein energy should be provided as INTRALIPID to supply sufficient amounts of linoleic and linolenic acid. If EFAD is associated with stress, the amount of INTRALIPID required to correct the deficiency may be substantially higher.

ELIMINATION OF LIPIDS

Adults.The ability to eliminate lipids must be closely monitored in patients with the conditions mentioned in the section “BEFORE USING INTRALIPID 200 mg/ml,” and in patients receiving INTRALIPID for more than one week. This is done by collecting a blood sample after a lipid-free clearance period of 5-6 hours. Blood cells are then separated from plasma by centrifugation. If the plasma is opalescent, the infusion must be postponed. The sensitivity of this method may cause hypertriglyceridemia to go unnoticed. Therefore, it is recommended that serum triglyceride concentrations be determined in patients who are likely to have altered lipid tolerance.

Newborns and children.The ability to eliminate lipids must be controlled regularly in newborns and children. The determination of serum triglyceride levels is the only reliable method.

If you use more INTRALIPID 200 mg/ml than you should:

See the section “POSSIBLE ADVERSE EFFECTS,” “Lipid overload syndrome.” Severe overdose of lipid emulsions containing triglycerides may, especially if carbohydrates are not administered simultaneously, lead to acidosis.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, INTRALIPID may cause side effects, although not everyone will experience them.

INTRALIPID infusion may cause an increase in body temperature and, less frequently, chills, tremors, and nausea/vomiting (<1%).

Reports of other adverse reactions related to INTRALIPID infusions are extremely rare, less than one adverse report per million infusions.

Thrombocytopenia associated with prolonged treatment with INTRALIPID has been reported in children. A transient increase in liver function tests has also been detected after prolonged intravenous nutrition with or without INTRALIPID. Elevated cholesterol levels have been observed in children after prolonged treatment with INTRALIPID. The reasons are not clear at present.

Lipid Overload Syndrome.A altered ability to eliminate INTRALIPID may lead to lipid overload syndrome as a result of overdose. However, this syndrome can also appear at recommended infusion rates associated with sudden changes in the patient's clinical condition, such as altered renal function or infection. Lipid overload syndrome is characterized by hyperlipemia, fever, lipid infiltration,alterations in various organs, and coma. All symptoms are generally reversible if INTRALIPID perfusion is stopped.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Store at a temperature below 25º C. Do not freeze.

Keep out of the reach and sight of children.

Do not use INTRALIPID after the expiration date that appears on the packaging after the CAD initials. The expiration date is the last day of the month indicated.

Do not use INTRALIPID if you observe that the packaging is damaged. For the bag: after inspecting the integrity indicator, the overbag should be removed.

Medicines should not be disposed of through drains or in the trash. Ask your doctor how to dispose of the packaging and unused medicines. This will help protect the environment.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from exposure to light until the end of administration (see section 2).

Composition of INTRALIPID 200 mg/ml

1 ml of emulsion contains:

The active ingredient is:

Purified soybean oil200 mg

The other components are: purified egg phospholipids, anhydrous glycerol, water for

parenteral preparations.

Aspect of the product and contents of the package

Infusion bag:The bag consists of an inner bag (primary packaging) with an outer bag. Between the inner bag and the outer bag, an oxygen absorber and an integrity indicator (Oxalert)

The outer bag, the oxygen absorber, and the integrity indicator must be discarded after opening the outer bag. The integrity indicator (OxalertTM) reacts with free oxygen and changes color in case of alteration of the outer bag.

Package sizes: bags of 100 ml, 250 ml, and 500 ml.

10 bags of 250 ml

12 bags of 500 ml

Only some types or sizes of packaging may be commercially available.

All components of the packaging materials are latex-free and PVC-free.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder: Fresenius Kabi España S.A.U

C/ Marina 16-18, Torre Mapfre 08005 Barcelona

Responsible manufacturer:

Fresenius Kabi AB

Rapsgatan 7, 751 82 Uppsala

Sweden

This leaflet was approved in October 2019.

Detailed and updated information on this medication is available on the website of the

Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for medical professionals or healthcare professionals

Instructions for use/manipulation

Use only if the packaging remains intact. For the bag: after inspecting the integrity indicator, the outer bag must be removed.

Admixtures must be added aseptically. Do not perform isolated addition of electrolyte solutions to INTRALIPID. Only solutions of medicine, nutrition, or electrolytes, whose compatibility has been documented, can be added directly. There are compatibility data available from the manufacturer for several mixtures. The remaining content of the opened bags must be discarded and not be preserved for subsequent use.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration.

Special precautions for storage

After addition of other nutritional elements

Mix in plastic bag (phthalate-free film): the aseptically prepared mixtures in a controlled and validated aseptic area must be used within 7 days after preparation. The mixtures can be stored for up to 6 days under refrigeration (2-8°C), followed by a maximum perfusion period of 24 hours.

Exposure to light of parenteral nutrition solutions for intravenous use, especially after mixing with oligoelements or vitamins, may have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, INTRALIPID must be protected from ambient light until the end of administration.

Special precautions for disposal and other manipulations:

When used in newborns and children under 2 years, it must be protected from exposure to light until the end of administration. Exposure of INTRALIPID to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from exposure to light.

Instructions for use

Fresenius Kabi infusion bags

1.Inspect the integrity indicator (Oxalert TM ) A before removing the outer bag. If the

indicator is black, oxygen has entered the outer bag and the product must be rejected.

2.Remove the outer bag by tearing along the perforation and pulling downwards along the packaging. The

bags Oxalert A and the oxygen absorber B must be discarded.

3.If additives are required, break the white addition port by the arrow mark (A). If no additives are required, go to point 5.

4.Insert the needle horizontally through the center of the addition port membrane and

inject the additives (of known compatibility). Use syringes with 18-23 gauge needles and a maximum length of 40 mm.

5.Use a perfusion device without air entry or close the air entry of the perfusion device. Follow the instructions for use of the perfusion device. Use a tip with the specified diameter in the ISO 8536-4, 5,6 +/- 0.1 mm standard.

1. Break the blue perfusion port by the arrow mark

1. Hold the base of the perfusion port. Insert the tip through the perfusion port
   by rotating the wrist slightly until the tip is inserted completely.

8.Hang the bag on the hanger by the perforated hole and start the perfusion.