Olimel n5e

OLIMEL N5E, emulsion for infusion
Please read the following information carefully before administration of the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Table of contents of the leaflet

1. What OLIMEL N5E, emulsion for infusion is and what it is used for
2. Important information before administration of OLIMEL N5E, emulsion for infusion
3. How to use OLIMEL N5E, emulsion for infusion
4. Possible adverse reactions
5. How to store OLIMEL N5E, emulsion for infusion
6. Contents of the pack and other information

1. What OLIMEL N5E, emulsion for infusion is and what it is used for

OLIMEL is an emulsion for infusion. The preparation is supplied in a three-compartment bag.
The first compartment contains a glucose solution with calcium, the second — a fat emulsion, and the
third — an amino acid solution with other electrolytes.
OLIMEL is used for intravenous nutrition administered through a tube in adults and children over 2
years of age, when oral nutrition is not appropriate.
OLIMEL may only be used under medical supervision.

2. Important information before administering OLIMEL N5E, emulsion for infusion

When not to use OLIMEL N5E, emulsion for infusion:

• in premature infants, newborns, and children under 2 years of age;
• if the patient is allergic to eggs, soy, peanut proteins, corn/corn-containing products (see also section “Warnings and precautions” below), or to any of the other components of this medicine (listed in section 6);
• if administration of certain amino acids causes an abnormal reaction in the patient;
• if the patient has markedly elevated blood lipid levels;
• if the patient has hyperglycemia (excessively high blood sugar levels);
• if the patient has abnormally high blood levels of any electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus).

In each case, the physician will make the decision to administer the drug based on factors such as the patient's age, body weight, and overall health status, including results of performed tests.
Warnings and precautions
Before starting OLIMEL N5E, discuss this with the doctor or nurse.
Infusing parenteral nutrition solutions too rapidly may result in injury or death of the patient.
If unusual signs or symptoms of an allergic reaction occur (such as sweating, fever, chills, headache, skin rash, or breathing difficulties), the infusion must be stopped immediately. The product contains soybean oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-reactivity between soy proteins and peanut proteins has been observed.
OLIMEL contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn-containing products (see section “When not to use OLIMEL N5E, emulsion for infusion” above).
Breathing difficulties may also indicate the formation of small particles blocking blood vessels in the lungs (pulmonary vessel deposits). If any breathing difficulties occur, inform the doctor or nurse immediately. They will decide on appropriate actions.
The antibiotic ceftriaxone must not be mixed or administered simultaneously with any solutions containing calcium (including OLIMEL) given by intravenous infusion. These drugs must not be administered simultaneously even through separate infusion lines or different infusion sites. However, OLIMEL and ceftriaxone may be administered sequentially if infusion lines are inserted at different sites, replaced, or thoroughly flushed with saline solution between infusions to prevent precipitation (formation of calcium ceftriaxone salt particles).
Certain medications and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). The risk of infection or sepsis is particularly high after insertion of a catheter (intravenous line) into the patient's vein. The physician will closely monitor the patient for any signs of infection. Patients requiring parenteral nutrition (administration of nutrients via a tube placed in a vein) are, due to their clinical condition, at increased risk of developing infections. Maintaining aseptic technique (ensuring absence of microorganisms) during catheter insertion, handling, and preparation of the nutritional formulation (total parenteral nutrition) may reduce the risk of infection.
If the patient is severely malnourished and requires intravenous feeding, the physician should initiate treatment slowly. The physician should also closely monitor the patient to prevent sudden changes in fluid volume, vitamin, electrolyte, and mineral concentrations.
Before starting the infusion, any disturbances in water-electrolyte balance and metabolic disorders in the patient should be corrected. The physician will monitor the patient during therapy and may adjust the dosage or, if deemed appropriate, prescribe additional nutritional supplements such as vitamins, electrolytes, and trace elements.
In patients receiving intravenous nutritional therapy, liver function disorders have been reported, including impaired bile excretion (cholestasis), fat accumulation (hepatic steatosis), fibrosis (possibly leading to liver failure), as well as cholecystitis and gallstones. The causes of these disorders are believed to vary among different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, or yellowing of the skin or eyes (jaundice), contact the physician to identify possible causes, contributing factors, and potential therapeutic or preventive measures.
Inform the physician:

• about severe kidney diseases. Also inform the physician if the patient is undergoing dialysis (artificial kidney) or other blood purification methods;
• about severe liver diseases;
• about blood coagulation disorders;
• about adrenal dysfunction (adrenal insufficiency). Adrenal glands are triangular-shaped glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about fluid accumulation in the body (overhydration);
• about insufficient body fluid (dehydration);
• about untreated high blood glucose levels (diabetes);
• about myocardial infarction or shock caused by acute heart failure;
• about severe metabolic acidosis (excessively acidic blood);
• about systemic infection (sepsis);
• about coma.

To monitor the efficacy and safety of the drug, the patient will undergo clinical and laboratory tests ordered by the physician during treatment. If the drug is administered for several weeks, the patient's blood will be tested regularly.
Reduced ability of the body to clear lipids contained in the administered preparation may lead to so-called fat overload syndrome (see section 4 – “Possible side effects”).
If pain, burning, swelling at the infusion site, or leakage of infused fluid occurs during infusion, notify the doctor or nurse immediately. Infusion will be stopped immediately and resumed into another vein.
If blood glucose levels rise excessively, the physician should adjust the infusion rate of OLIMEL or administer insulin to normalize blood sugar levels.
OLIMEL may be administered through a catheter inserted into a large vein in the patient's chest (central vein).
Children and adolescents
When used in children under 18 years of age, particular caution is required to ensure correct dosing. Due to children's increased susceptibility to infection, enhanced precautions must be taken. Vitamin and trace element supplementation is always required. Pediatric formulations and dosages must be used for children.
OLIMEL and other medicines
Inform the physician about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use.
Concurrent use of other medicines is generally not contraindicated. However, it is essential to inform the physician about all recently taken medicines, including those available without a prescription, to verify compatibility.
Inform the physician about the use or administration of:

• insulin,
• heparin.

OLIMEL must not be administered simultaneously with blood through the same infusion set.
OLIMEL contains calcium. It must not be administered together with the antibiotic ceftriaxone or through the same line, as particles may form. If these drugs are administered sequentially using the same device, it must be thoroughly flushed.
Due to the risk of precipitation, OLIMEL should not be administered through the same infusion line or mixed with ampicillin (an antibiotic) or fosphenytoin (an anticonvulsant).
The olive oil and soybean oil present in OLIMEL contain vitamin K. This usually does not affect the action of anticoagulant drugs (blood thinners) such as coumarin. However, if the patient is taking anticoagulants, they should inform the physician.
Lipids in the emulsion may interfere with results of certain laboratory tests if blood samples are taken before lipids are cleared from the patient's circulation (lipids are cleared from blood within 5 to 6 hours after administration).
OLIMEL contains potassium. Particular caution is required in patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (medicines used for hypertension), or immunosuppressive drugs. These drugs may cause increased blood potassium levels.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the physician before receiving this medicine.
There is insufficient experience regarding the use of OLIMEL N5E in pregnant or breastfeeding women. If necessary, administration of OLIMEL N5E may be considered during pregnancy and breastfeeding. OLIMEL N5E should be administered to pregnant or breastfeeding women only after careful consideration.
Driving and operating machinery
Not applicable.

3. How to use OLIMEL N5E, infusion emulsion

Dosage
OLIMEL must be used only in adults and children above the age of 2 years.
The medicine is an infusion emulsion administered via a catheter into a large vein in the patient's chest.
Before administration, OLIMEL should be at room temperature.
OLIMEL is intended for single use only.
Infusion of one bag usually lasts from 12 to 24 hours.

Dosage – Adults
The infusion rate will be determined by the physician according to the patient's needs and clinical condition.
The medicine may be administered for as long as necessary, depending on the patient's clinical status.

Dosage – Children above two years of age and adolescents
The dose and duration of treatment will be determined by the physician, depending on age, body weight, height, health status, and the body's ability to metabolize and utilize the components of OLIMEL N5E.

Overdose of OLIMEL N5E, infusion emulsion
In case of administration of an excessive dose or too rapid infusion, the amino acids contained in the product may contribute to increased blood acidity and symptoms of hypervolemia (increased circulating blood volume). Blood and urinary glucose levels may rise, hyperosmolarity syndrome (excessive blood viscosity) may develop, and the lipids contained in the emulsion may increase blood triglyceride levels. Administration of OLIMEL at too high an infusion rate or in excessive volume may cause nausea, vomiting, chills, headache, hot flushes, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such cases, the infusion must be stopped immediately.

In severe cases, the physician may need to initiate temporary kidney dialysis to assist the patient's kidneys in eliminating the excess medicine.

To prevent such situations, the physician regularly monitors the patient's condition and checks blood parameters.
If you have any doubts regarding the use of the medicine, consult your physician.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any changes in your condition during or after treatment, you should inform your doctor or nurse immediately.
Examinations performed by the doctor during the patient's treatment should minimize the risk of adverse effects.
If any unusual signs or symptoms of an allergic reaction occur, such as excessive sweating, fever, chills, headache, skin rash, or breathing difficulties, the infusion should be stopped immediately.

The following adverse effects have been reported during the use of OLIMEL preparation:
Frequency — Common: may affect up to 1 in 10 people

• Increased heart rate (tachycardia);
• Decreased appetite;
• Increased blood fat levels (hypertriglyceridemia);
• Abdominal pain;
• Diarrhea;
• Nausea;
• Increased arterial blood pressure (hypertension).

Frequency — Not known: frequency cannot be estimated from the available data

• Hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, macular, generalized rash), itching, hot flushes, breathing difficulties;
• Infusion leakage into surrounding tissue (extravasation) may lead to pain, irritation, swelling/edema, redness (erythema)/warmth, tissue cell death (skin necrosis), or blisters/bullae, inflammation, thickening or tightening of the skin at the infusion site;
• Vomiting.

During the use of similar parenteral nutrition preparations, the following adverse effects have been reported:
Frequency — Very rare: may affect up to 1 in 10,000 people

• Reduced ability to clear lipids (fat overload syndrome) associated with sudden deterioration in the patient's condition. The symptoms of fat overload syndrome listed below usually resolve after discontinuation of the fat emulsion infusion:
  o Fever
  o Decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anemia)
  o Low number of white blood cells, which may increase the risk of infections (leukopenia)
  o Low platelet count, which may increase the risk of bruising and/or bleeding (thrombocytopenia)
  o Coagulation disorders affecting the blood's ability to clot
  o High blood fat levels (hyperlipidemia)
  o Fatty infiltrations in the liver (hepatomegaly)
  o Worsening liver function
  o Central nervous system symptoms (e.g. coma).

Frequency — Not known: frequency cannot be estimated from the available data

• Allergic reactions;
• Abnormal blood test results indicating liver function abnormalities;
• Problems with bile excretion (cholestasis);
• Enlargement of the liver (hepatomegaly);
• Liver diseases associated with parenteral nutrition (see section 2, "Warnings and precautions");
• Jaundice;
• Decreased platelet count (thrombocytopenia);
• Increased blood nitrogen levels (azotemia);
• Elevated liver enzyme activity;
• Formation of small particles that may cause blockage of blood vessels in the lungs (pulmonary vessel precipitates), leading to pulmonary embolism and breathing difficulties (respiratory failure).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store OLIMEL N5E, infusion emulsion

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and outer packaging (MM/YYYY). The expiry date refers to the last day of the specified month.
Do not freeze.
Store in the original outer packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the package and other information

What OLIMEL N5E, infusion emulsion contains
The active substances in each bag of ready-to-use emulsion are: 8.2% (corresponding to 8.2 g/100 ml)
solution of L-amino acids (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (as lysine acetate), methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, aspartic acid, glutamic acid) with electrolytes (sodium, potassium, magnesium, phosphates, acetates, chlorides), 20% (corresponding to 20 g/100 ml) fat emulsion (purified olive oil and purified soybean oil), and 28.75% (corresponding to 28.75 g/100 ml) glucose solution (as glucose monohydrate) with calcium.
Other components of the medicine are:

What OLIMEL N5E, infusion emulsion looks like and what the packaging contains
OLIMEL is an infusion emulsion supplied in a three-chamber bag. The first chamber contains a lipid emulsion, the second chamber contains an amino acid solution with electrolytes, and the third chamber contains a glucose solution with calcium. The chambers are separated from each other by impermeable seals. Before administration, the contents of each chamber should be mixed by squeezing the bag towards itself, starting from the top of the bag, until the seals open.

Appearance before mixing:

• Amino acid and glucose solutions are clear, colourless or slightly yellow.
• The lipid emulsion is homogeneous with a milky appearance.

Appearance after mixing: homogeneous emulsion with a milky appearance.
The three-chamber bag is a multilayer plastic pouch. The inner (contact) layer of the bag is compatible with the components and permitted additives.
To prevent contact with oxygen present in the air, the bag is packed in an oxygen-protective packaging with an oxygen-absorbing sachet.

Pack sizes
1500 ml bag: 1 cardboard box containing 4 bags
2000 ml bag: 1 cardboard box containing 4 bags
2500 ml bag: 1 cardboard box containing 2 bags
1 bag of 1500 ml, 2000 ml and 2500 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Polska Sp. z o.o.
Ul. Kruczkowskiego 8
00-380 Warszawa
Poland

Manufacturer
BAXTER S.A.
Boulevard Rene Branquart 80
7860 Lessines, Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:
France, Portugal, Estonia, Poland, Lithuania, Bulgaria, Romania, Latvia, Czech Republic, Belgium, Spain, Slovakia, Netherlands, Luxembourg, Slovenia, Italy, Greece, Cyprus: OLIMEL N5E

In some countries it is registered under a different trade name as described below:
Austria: ZentroOLIMEL 3,3 % mit Elektrolyten
Germany: Olimel 3,3% E
Denmark, Iceland, Sweden, Norway, Finland: Olimel N5E
United Kingdom, Ireland, Malta: Triomel 5g/l nitrogen 990 kcal/l with electrolytes

Information intended exclusively for healthcare professionals:

Pharmacotherapeutic group: parenteral nutrition solutions / mixtures
ATC code: B05 BA10.
A. QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL is provided in a three-compartment bag.
Each bag contains a glucose solution with calcium, a fat emulsion, and an amino acid solution with other electrolytes:

Composition of the ready emulsion after mixing the contents of the three chambers:

The excipients are:

Nutritional values of the ready-to-use emulsion, according to bag sizes:

B. DOSAGE AND ADMINISTRATION
Dosage
OLIMEL is not recommended for use in children under 2 years of age due to its unsuitable composition and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).
The maximum daily dose specified below must not be exceeded. Because of the fixed composition of the multi-chamber bag, it may not be possible to meet all of the patient's nutritional requirements simultaneously. There may be clinical situations in which patients require different amounts of nutrients than those contained in the fixed-composition bag. In such cases, any change in volume (dose) should take into account the impact this will have on the dosing of all other nutrients provided by the medicinal product OLIMEL.

Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL, as well as on additional energy components or proteins administered orally/enterally; therefore, the appropriate bag size should be selected accordingly.
The average daily requirements are:

• 0.16 to 0.35 g nitrogen/kg body weight (1–2 g amino acids/kg), depending on the patient's nutritional status and degree of catabolism,
• 20 to 40 kcal/kg,
• 20 to 40 mL fluid/kg or 1 to 1.5 mL per kcal consumed.

For the OLIMEL product, the maximum daily dose is defined as 40 mL fluid/kg, corresponding to 1.3 g amino acids/kg, 4.6 g glucose/kg, 1.6 g lipids/kg, 1.4 mmol sodium/kg, and 1.2 mmol potassium/kg. For a 70 kg patient, this would correspond to 2800 mL of OLIMEL per day, representing an intake of 92 g amino acids, 322 g glucose, and 112 g lipids (i.e., 2408 non-protein kcal and a total of 2772 kcal).
Typically, the infusion rate should be gradually increased during the first hour, after which the infusion rate should be appropriately adjusted according to the required dose, daily volume of the medicinal product, and duration of infusion.
For the OLIMEL product, the maximum infusion rate is 2.1 mL/kg/hour, corresponding to 0.07 g amino acids/kg/hour, 0.24 g glucose/kg/hour, and 0.08 g lipids/kg/hour.

Children over 2 years of age and adolescents
Studies have not been conducted in the pediatric population.
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL, as well as on additional energy components or proteins administered orally/enterally; therefore, the appropriate bag size should be selected accordingly.
Furthermore, daily requirements for fluids, nitrogen, and energy continuously decrease with age. Two age groups have been considered: 2 to 11 years and 12 to 18 years.
For the OLIMEL N5E product in both age groups, magnesium concentration is the limiting factor for the daily dose. In the 2 to 11-year age group, glucose and lipid concentrations are the limiting factors for the hourly administration rate. In the 12 to 18-year age group, glucose concentration is the limiting factor for the hourly administration rate. The resulting intake recommendations are presented below:

Typically, the infusion rate should be gradually increased during the first hour, and then adjusted according to the administered dose, daily volume of the medicinal product and duration of infusion.
Generally, in small children, it is recommended to start with a low daily dose and gradually increase it to the maximum dosage (see above).
Method and duration of administration
For single use only.
It is recommended to use the contents of the bag immediately after opening and not to store it for subsequent infusions.
After mixing, a homogeneous milky-appearing emulsion is obtained.
Instructions for the preparation and use of the infusion emulsion are described in section 6.6 of the SmPC.
Due to its high osmolarity, OLIMEL must be administered only via a central vein.
The recommended duration of infusion for the parenteral nutrition bag is from 12 to 24 hours.
Parenteral nutrition treatment may be continued as long as clinically indicated.
C. PHARMACEUTICAL INCOMPATIBILITIES
Do not add any medicinal products or substances to any of the bag components or to the final emulsion without prior confirmation of their compatibility and stability of the resulting product (especially the stability of the fat emulsion).
Incompatibilities may occur, for example, due to excessive acidity (low pH) or inappropriate content of divalent cations (Ca and Mg), which may destabilize the fat emulsion.
As with the preparation of other parenteral nutrition mixtures, the ratio of calcium and phosphate content should be considered. Excessive addition of calcium and phosphate, particularly in the form of inorganic salts, may lead to precipitation of calcium phosphate.
OLIMEL contains calcium ions, which pose an additional risk of clot formation in blood products or blood components containing citrate as an anticoagulant/preservative.
Ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium, including OLIMEL, through the same infusion line (e.g. via a Y-connector) due to the risk of precipitation of ceftriaxone-calcium salts (see sections 4.4 and 4.5 of the SmPC). Ceftriaxone and calcium-containing solutions may be administered consecutively if infusion lines are inserted at different sites or are replaced or thoroughly flushed with physiological saline between infusions to prevent precipitation.
Due to the risk of precipitation, the medicinal product OLIMEL should not be administered through the same infusion line or mixed with ampicillin or fosphenytoin.
Compatibility with solutions administered simultaneously through the same infusion set, catheter or cannula should be verified.
Due to the risk of pseudoagglutination, this product should not be administered before, during or after blood transfusion through the same infusion set.
D. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION
The steps for preparing OLIMEL for administration are illustrated in Figure 1.
Opening
Remove the outer protective bag.
Discard the sachet containing the oxygen absorber.
Check that the bag and seals are undamaged. Use only if the bag is intact, the seals are unbroken (i.e. the contents of the three compartments have not been mixed), the amino acid and glucose solutions are clear, colorless or slightly yellowish, practically free from visible particles, and the fat emulsion is homogeneous and milky-appearing.
Mixing of solutions and emulsion
Ensure the product is at room temperature before breaking the seals.
Starting from the top of the bag (at the handle), roll the bag downward with both hands. The seals will disappear progressively from the port side. Continue rolling until the seals are broken halfway along their length.
Mix thoroughly by rotating the bag at least three times.
After mixing, the product forms a homogeneous milky-appearing emulsion.
Additional components
The bag capacity is sufficient to allow addition of vitamins, electrolytes and trace elements.
All additives (including vitamins) should be added to the final emulsion (after breaking the seals and mixing the contents of the three compartments).
Vitamins may also be added to the glucose compartment before preparing the final emulsion (before breaking the seals and mixing the contents of the three compartments).
When adding additional components to products containing electrolytes, the amount of electrolytes already present in the bag must be taken into account.
Additional components must be added by qualified personnel under aseptic conditions.
Electrolytes may be added to OLIMEL according to the table below:

Trace elements and vitamins:
Stability has been demonstrated after addition of commercially available vitamin and trace element products
(containing up to 1 mg of iron).
Compatibility with other additional components is available upon request.
When adding components, the following steps should be taken:

• maintain aseptic conditions,
• prepare the injection site on the bag,
• puncture the injection site and inject the additional components using a syringe or a drug preparation device,
• mix the contents of the bag thoroughly after addition of components.

Infusion preparation
Maintain aseptic conditions.
Hang the bag.
Remove the plastic protector from the medication port.
Firmly insert the infusion set spike into the medication port.
Figure 1. Steps for preparing OLIMEL for administration.

2. 3.

5. 6.

Administration
For single use only.
Administer the product only after breaking the seals between the 3 chambers and thoroughly mixing their contents.
Ensure that no phase separation occurs in the final infusion emulsion.
After opening, the bag contents must be used immediately. Do not store an opened bag for subsequent infusions.
Do not reconnect partially used bags.
To avoid the risk of air embolism caused by gas present in the first bag, do not connect bags in series.
Any unused portion of the product, waste material, and the entire infusion set must be discarded.

Extravasation
The catheter insertion site should be regularly monitored for signs of extravasation.
In case of extravasation, administration must be stopped immediately, while leaving the inserted catheter or cannula in place to allow immediate initiation of appropriate medical management.
If possible, before removing the catheter/cannula, aspirate fluid through it to reduce the amount of fluid in the tissues.
Depending on the type of extravasated product (including any product(s) mixed with OLIMEL, if applicable) and the extent/severity of potential tissue injury, appropriate specific countermeasures should be taken.
Management options may include non-pharmacological treatment, pharmacological treatment, and/or surgical intervention.
In cases of extensive extravasation, consultation with a plastic surgeon should be sought within 72 hours.
The extravasation site should be monitored at least every four hours during the first 24 hours, and then once daily.
Do not restart infusion into the same central vein.

Baxter and Olimel are trademarks of Baxter International Inc.