Intralipid 200 mg/ml emulsion for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
INTRALIPID 200 mg/ml emulsion for infusion
Purified soybean oil
Read the entire leaflet carefully before starting to use the medicine:
the same symptoms, as it may harm them.
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In this leaflet:
- What INTRALIPID 200 mg/ml is and what it is used for
- Before using INTRALIPID 200 mg/ml
- How to use INTRALIPID 200 mg/ml
- Possible side effects
- How to store INTRALIPID 200 mg/ml
- Additional information for healthcare professionals
1. What INTRALIPID 200 mg/ml is and what it is used for
INTRALIPID 200 mg/ml is a lipid emulsion for intravenous infusion. It is supplied in plastic bags with overpouch in sizes of 100 ml, 250 ml, and 500 ml. It belongs to a group of medicines called intravenous solutions for parenteral nutrition.
INTRALIPID is indicated in patients requiring intravenous nutritional support to provide energy and essential fatty acids. INTRALIPID is also indicated in patients with essential fatty acid deficiency (EFAD) who cannot maintain or restore a normal essential fatty acid pattern through oral intake.
2. BEFORE USING INTRALIPID 200 mg/ml
Do not use INTRALIPID 200 mg/ml:
INTRALIPID is contraindicated in patients with acute shock and in patients with severe hyperlipidemia. Severe hepatic insufficiency. Hemophagocytic syndrome.
Hypersensitivity (allergy) to egg, soybean, or peanut protein, or to any of the active substances or excipients.
Take special care with INTRALIPID 200 mg/ml:
INTRALIPID should be administered with caution in patients with lipid metabolism disorders such as renal insufficiency, decompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (if hypertriglyceridemia is present), and sepsis. When administering INTRALIPID to patients in these conditions, strict monitoring of serum triglyceride concentrations is mandatory.
This product contains soybean oil and egg phospholipids, which may very rarely cause allergic reactions. Cross-allergic reactions between soybean 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 receiving long-term parenteral nutrition, platelet count, liver function tests, and serum triglyceride concentrations should be monitored.
INTRALIPID may interfere with certain laboratory determinations (bilirubin, lactate dehydrogenase, oxygen saturation, Hb, etc.) if blood samples are taken before lipids have been adequately cleared from the bloodstream. Lipids are cleared after a lipid-free period of 5–6 hours in most patients.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until the end of administration. Exposure of INTRALIPID to ambient light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the product from light exposure.
Use with other medicines:
Some drugs, such as insulin, may interfere with the body's lipase system. However, this type of interaction has only minor clinical significance.
Heparin, at therapeutic doses, causes a transient increase in plasma lipolysis, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.
Soybean oil contains vitamin K1, which should be taken into account in patients receiving coumarin derivatives, as these interfere with vitamin K1.
This medicine must not be mixed with other products unless compatibility data are available.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medicine.
No adverse effects have been reported during pregnancy and breastfeeding.
Driving and using machines:
Effects on the ability to drive and use machinery are not expected.
3. HOW TO USE INTRALIPID 200 mg/ml
Follow exactly the instructions for administration of Intralipid 200 mg/ml given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Due to the risk of microbial contamination, an opened container must be infused within a maximum of 24 hours.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until the end of administration (see section 2).
Dosage and method of administration
The capacity to eliminate INTRALIPID determines the dosage and infusion rate. See below, Lipid clearance.
DOSAGE
1 g of triglycerides corresponds to 5 ml of INTRALIPID 200 mg/ml.
Adults. The recommended maximum dose is 3 g of triglycerides/kg body weight/day. When administering at this upper limit, INTRALIPID provides 70% of energy requirements, even in patients with significantly increased energy needs. The infusion rate for INTRALIPID must not exceed 500 ml over 5 hours.
Neonates and children. The recommended dosage range in neonates 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 preterm infants and low-birth-weight neonates, INTRALIPID should preferably be infused continuously over 24 hours. The initial dose should be 0.5–1 g/kg body weight/day, followed by gradual increments of 0.5–1 g/kg body weight/day up to 2 g/kg body weight/day. The dose may be increased up to 4 g/kg body weight/day only under close monitoring of serum triglyceride concentrations, liver function tests, and oxygen saturation. The rates indicated are maximum rates and must not be exceeded in order to compensate for missed doses.
Essential fatty acid deficiency (EFAD). To prevent or correct essential fatty acid deficiency, 4–8% of non-protein energy should be provided as INTRALIPID in order to supply sufficient amounts of linoleic and linolenic acids. If EFAD is associated with stress, the amount of INTRALIPID required to correct the deficiency may be substantially higher.
LIPID CLEARANCE
Adults. The capacity to clear lipids must be closely monitored in patients with the conditions mentioned in 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-clearance period of 5–6 hours. Blood cells are then separated from plasma by centrifugation. If the plasma is opalescent, infusion should be postponed. The sensitivity of this method may result in undetected hypertriglyceridemia. Therefore, it is recommended that serum triglyceride concentrations be determined in patients likely to have altered lipid tolerance.
Neonates and children. The capacity to clear lipids must be regularly monitored in neonates and children. Measurement of serum triglyceride levels is the only reliable method.
If you use more INTRALIPID 200 mg/ml than you should:
See section “POSSIBLE ADVERSE EFFECTS”, “Lipid overload syndrome”. Severe overdose of lipid emulsions containing triglycerides may, especially if carbohydrates are not simultaneously administered, lead to acidosis.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, INTRALIPID can cause adverse effects, although not everybody experiences them.
Infusion of INTRALIPID may cause an increase in body temperature and, less frequently, chills, tremors, and nausea/vomiting (incidence < 1%).
Reports of other adverse reactions associated with INTRALIPID infusions are extremely rare, with less than one adverse report per million infusions.
MedDRA System Organ Class | Frequency | Adverse Reaction |
General disorders and administration site conditions | Uncommon (more than 1 in 1,000, less than 1 in 100) Very rare (less than 1 in 10,000) | Headache, increased body temperature, chills, shivering, fatigue Anaphylactic reaction (allergic reaction) |
Cardiac disorders | Very rare (less than 1 in 10,000) | Circulatory effects e.g. hyper/hypotension (high/low blood pressure) |
Gastrointestinal disorders | Uncommon (more than 1 in 1,000, less than 1 in 100) | Abdominal pain, nausea, vomiting |
Hepatobiliary disorders | Very rare (less than 1 in 10,000) | Transient increase in liver function tests |
Musculoskeletal and connective tissue disorders | Very rare (less than 1 in 10,000) | Abdominal pain |
Platelet, bleeding and coagulation disorders | Very rare (less than 1 in 10,000) | Thrombocytopenia (reduced platelet count) |
Red blood cell disorders | Very rare (less than 1 in 10,000) | Hemolysis (breakdown of red blood cells), reticulocytosis (increased reticulocytes) |
Reproductive system disorders, male | Very rare (less than 1 in 10,000) | Priapism (prolonged penile erection) |
Skin and subcutaneous tissue disorders | Very rare (less than 1 in 10,000) | Rash, urticaria |
Thrombocytopenia has been reported in children receiving prolonged treatment with INTRALIPID. Transient increases in liver function tests have also been observed after prolonged intravenous nutrition with or without INTRALIPID. Increased cholesterol levels have been observed in children following prolonged treatment with INTRALIPID. The reasons for this are currently unclear.
Lipid overload syndrome. Impaired ability to eliminate INTRALIPID may lead to a lipid overload syndrome as a result of overdosage. However, this syndrome may also occur at recommended infusion rates, associated with sudden changes in the patient's clinical condition, such as impaired renal function or infection. Lipid overload syndrome is characterized by hyperlipidemia, fever, lipid infiltration, multi-organ dysfunction, and coma. All symptoms are generally reversible if the INTRALIPID infusion is discontinued.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of INTRALIPID 200 mg/ml
Store below 25°C. Do not freeze.
Keep out of the reach and sight of children.
Do not use INTRALIPID after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Do not use INTRALIPID if you notice that the container is damaged. For the bag: after inspection of the integrity indicator, the overpouch must be removed.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).
6. ADDITIONAL INFORMATION
Composition of INTRALIPID 200 mg/ml
1 ml of emulsion contains:
The active substance is:
Purified soybean oil 200 mg
The other components are: purified egg phospholipids, glycerol (anhydrous), water for
injectable preparations.
Appearance of the product and contents of the container
Infusion bag: the bag consists of an inner bag (primary packaging) with an overpouch. Between the inner bag and the overpouch, an oxygen absorber and an integrity indicator (Oxalert) are placed.
The overpouch, oxygen absorber, and integrity indicator must be discarded after opening the overpouch. The integrity indicator (OxalertTM) reacts with free oxygen and changes color if the overpouch has been compromised.
Pack sizes: 100 ml, 250 ml, and 500 ml bags.
10 bags of 250 ml
12 bags of 500 ml
Only certain pack types or sizes may be marketed.
All components of the packaging materials are latex-free and PVC-free.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Fresenius Kabi España S.A.U
C/ Marina 16-18, Torre Mapfre 08005 Barcelona
Manufacturer:
Fresenius Kabi AB
Rapsgatan 7, 751 82 Uppsala
Sweden
This summary of product characteristics was approved in October 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es
This information is intended solely for healthcare professionals
Instructions for use/handling
Do not use unless the packaging remains intact. For the bag: after inspecting the integrity indicator, remove the overpouch.
Additions must be made aseptically. Do not add isolated electrolyte solutions to INTRALIPID. Only medicinal, nutritional, or electrolyte solutions with documented compatibility may be added directly. Compatibility data are available from the manufacturer for several mixtures. Any remaining contents of opened bags must be discarded and not stored for future use.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete.
Special storage precautions
After addition of other nutritional components
Mixture in plastic bag (phthalate-free film): mixtures prepared aseptically in a controlled and validated aseptic environment should be used within 7 days of preparation. Mixtures may be stored for up to 6 days under refrigeration (2–8°C), followed by a maximum infusion period of 24 hours.
Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with trace elements or vitamins, may have adverse effects on clinical outcomes in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, INTRALIPID must be protected from ambient light until administration is complete.
Special precautions for disposal and other handling:
When used in newborns and children under 2 years of age, the product must be protected from light exposure until administration is complete. Exposure of INTRALIPID to ambient light, particularly after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the product from light.
Instructions for use
Fresenius Kabi infusion bags
- Inspect the integrity indicator (Oxalert TM) A before removing the overpouch. If the
indicator is black, oxygen has entered the overpouch and the product must be rejected.
- Remove the overpouch by tearing at the notch and pulling downward along the container. The
Oxalert bag A and oxygen absorber B must be discarded.
- If additives are required, break the white additive port at the arrow-shaped mark (A). If no additives are required, proceed to step 5.
- Insert the needle horizontally through the center of the membrane of the additive port and inject the additives (with known compatibility). Use syringes with needles of gauge 18–23 and a maximum length of 40 mm.
- Use an infusion set without an air inlet or close the air inlet of the infusion set. Follow the infusion set manufacturer's instructions. Use a spike with a diameter specified in ISO 8536-4: 5.6 +/- 0.1 mm.
- Break the blue infusion port at the arrow-shaped mark.
- Hold the base of the infusion port. Insert the spike into the infusion port with a slight wrist rotation until the spike is fully inserted.
- Hang the bag on the hanger using the perforated notch and begin infusion.
