Olimel N5e

Patient Information Leaflet: User Information

OLIMEL N5E, infusion emulsion

Read the leaflet carefully before administering the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

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

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

2. Important information before administering OLIMEL N5E, infusion emulsion

When not to use OLIMEL N5E, infusion emulsion:

• -in premature infants, newborns, and children under 2 years of age;
• -if the patient is allergic to eggs, soy, peanut proteins, corn/corn products (see also "Warnings and precautions" below) or any of the other ingredients of this medicine (listed in section 6);
• -if the use of certain amino acids causes an abnormal reaction in the patient's body;
• -if the patient has a particularly high level of fats in the blood;
• if the patient has hyperglycemia (too high blood sugar levels);
• if the patient's blood has an abnormally high content of any of the electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus).

In each case, the doctor will decide on the administration of the medicine based on factors such as age, body weight, and the patient's health status, including the results of tests performed.

Warnings and precautions

Before starting the administration of OLIMEL N5E, discuss it with your doctor or nurse.
Too rapid administration of total parenteral nutrition solutions 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 should be stopped immediately. The medicine contains soybean oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins.
The OLIMEL medicine contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn products (see "When not to use OLIMEL N5E, infusion emulsion" above).
Breathing difficulties may also be a sign that small particles blocking blood vessels in the lungs (pulmonary embolism) have formed. If any breathing difficulties occur, tell your doctor or nurse. They will decide on the appropriate action.
The antibiotic ceftriaxone should not be mixed or administered simultaneously with any calcium-containing solutions (including OLIMEL) by intravenous drip.
These medicines should not be administered simultaneously even through different infusion lines or infusion sites.
However, OLIMEL and ceftriaxone can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are exchanged or thoroughly flushed with physiological saline solution between infusions to avoid precipitate formation.
Certain medicines and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis after the insertion of a tube (central venous catheter) into the patient's vein. The doctor will closely monitor the patient to detect any signs of infection. Patients requiring parenteral nutrition (administration of nutrients through a tube inserted into a vein) are, due to their clinical condition, more susceptible to infection. Using aseptic procedures during catheter placement, handling, and preparation of the nutrition mixture (total parenteral nutrition) can reduce the risk of infection.
If the patient is severely malnourished, so that they need to receive food into a vein, the doctor should start treatment slowly. At the same time, the doctor should closely monitor the patient to prevent sudden changes in fluid volume, vitamin, electrolyte, and mineral levels.
Before starting the infusion, the patient's water and electrolyte balance and metabolic disorders should be corrected. The doctor will monitor the patient during therapy and may change the dosage or prescribe additional nutritional supplements such as vitamins, electrolytes, and trace elements if necessary.
In patients receiving intravenous nutrition therapy, liver function disorders have been reported, including difficulties in bile elimination (cholestasis), fat accumulation (fatty liver), fibrosis, possibly leading to liver failure, as well as gallbladder inflammation and gallstones. The causes of these disorders are considered to be different in different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, they should consult a doctor to identify possible causes and therapeutic measures.
The doctor should be informed:

• about severe kidney diseases. The doctor should also be informed if the patient is undergoing dialysis (artificial kidney) or other blood purification methods;
• about severe liver diseases;
• about blood coagulation disorders;
• about adrenal gland disorders (adrenal insufficiency). The adrenal glands are triangular glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about water accumulation in the body (overhydration);
• about insufficient water in the body (dehydration);
• about untreated high blood sugar levels (diabetes);
• about heart attack or shock caused by sudden heart failure;
• about severe metabolic acidosis (too acidic blood);
• about sepsis (generalized infection);
• about coma.

To check the effectiveness and safety of the medicine, the patient will undergo clinical and laboratory tests ordered by the doctor during the administration of the medicine. If the medicine is administered for several weeks, the patient's blood will be regularly tested.
A reduced ability of the body to eliminate lipids contained in the administered preparation may result in a so-called fat overload syndrome (see section 4 - "Possible side effects").
In the event of pain, burning, or swelling at the infusion site or leakage of the infused fluid during infusion, the doctor or nurse should be notified.
The administration of the preparation will be stopped immediately and then resumed in a different vein.
If blood sugar levels increase excessively, the doctor should adjust the rate of administration of the OLIMEL preparation or administer a medicine that regulates blood sugar levels (insulin).
OLIMEL can be administered through a tube (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 should be exercised to administer the correct dose of the preparation. Due to the increased susceptibility of children to the risk of infection, increased precautions should also be taken. Vitamin and trace element supplementation is always required. For children, pediatric compositions and quantities must be used.

OLIMEL and other medicines

Tell your doctor about all medicines you are taking or using now or recently, and about medicines you plan to take or use.
Concomitant use of other medicines is usually not contraindicated. However, you should inform your doctor about all medicines taken recently, including those available without a prescription, to check their compatibility.
Inform your doctor about taking or receiving:

• insulin,
• heparin.

Do not administer the OLIMEL medicine simultaneously with blood through the same infusion set.
OLIMEL contains calcium. It should not be administered together with the antibiotic ceftriaxone or through the same tube, as particles may form. If these medicines are administered sequentially using the same device, it should be thoroughly flushed.
Due to the risk of precipitate formation, the OLIMEL medicine should not be administered through the same infusion line or added to ampicillin (antibiotic) or fosphenytoin (antiepileptic medicine).
The olive and soybean oil present in the OLIMEL preparation contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as coumarin. However, if you are taking anticoagulant medicines, you should inform your doctor.
The fats contained in the emulsion may interfere with the results of some laboratory tests if the blood sample for the test is taken before the fats are eliminated from the patient's bloodstream (they are eliminated from the blood after 5 to 6 hours after fat administration).
OLIMEL contains potassium. Particular caution should be exercised in patients taking diuretic medicines, ACE inhibitors, angiotensin II receptor antagonists (medicines used in hypertension), or immunosuppressive medicines. These types of medicines may cause an increase in potassium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
There is limited experience with the use of OLIMEL N5E in pregnant or breastfeeding women. If necessary, the use of OLIMEL N5E during pregnancy and breastfeeding can be considered. OLIMEL N5E should be administered to pregnant or breastfeeding women only after careful consideration.

Driving and using machines

Not applicable.

3. How to use OLIMEL N5E, infusion emulsion

Dosage

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

Dosage - adults

The rate of administration, according to the patient's needs and clinical condition, will be determined by the doctor.
The medicine can be used for as long as necessary, depending on the patient's clinical condition.

Dosage - children over 2 years of age and adolescents

The dose of the medicine and the duration of administration are determined by the doctor, depending on the age, body weight, height, health status, and the body's ability to break down and utilize the components of the OLIMEL N5E preparation.

Administration of a higher dose of OLIMEL N5E, infusion emulsion than recommended

In the event of administration of too high a dose of the medicine or too rapid infusion, the contained amino acids may contribute to an increase in blood acidity and the occurrence of symptoms of hypervolemia (increased blood volume). Blood sugar levels and urine sugar levels may increase, and a hyperosmolar syndrome (excessive blood viscosity) may occur, and the fats contained in the emulsion may increase the level of triglycerides in the blood. Administration of an infusion that is too rapid or too large in volume may cause nausea, vomiting, chills, headache, heat strokes, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such a situation, the infusion should be stopped immediately.
In some severe cases, to support the patient's kidneys in eliminating the excess medicine, the doctor may be forced to subject the patient to temporary kidney dialysis.
To prevent such situations, the doctor regularly monitors the patient's condition and checks blood parameters.
In case of doubts related to the use of the medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any changes in your well-being during treatment or after its completion, tell your doctor or nurse immediately.
Tests performed by the doctor during the use of the medicine by the patient should minimize the risk of side 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 side effects have been reported during the use of the OLIMEL preparation:
Frequency - Common: may affect up to 1 in 10 people

• rapid heartbeat (tachycardia);
• decreased appetite;
• increased fat levels in the blood (hypertriglyceridemia);
• abdominal pain;
• diarrhea;
• nausea;
• increased blood pressure (hypertension).

Frequency - Unknown: frequency cannot be estimated from the available data

• hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, maculopapular, generalized rash), itching, heat strokes, breathing difficulties;
• infusion site extravasation (leakage of the infused fluid into the surrounding tissue) may lead to pain, irritation, swelling/edema, redness (erythema)/heat, tissue necrosis (skin necrosis) or blisters/bullae, inflammation, thickening or tightening of the skin at the infusion site;
• vomiting.

The following side effects have been reported during the use of similar parenteral nutrition preparations:
Frequency - Very rare: may affect up to 1 in 10,000 people

• Fat overload syndrome associated with sudden worsening of the patient's condition. The symptoms of fat overload syndrome usually resolve after discontinuation of the fat emulsion infusion. o Fever o Decreased red blood cell count, which can cause pale skin and be the cause of weakness or shortness of breath (anemia) o Low white blood cell count, which can increase the risk of infection (leukopenia) o Low platelet count, which can increase the risk of bruising and/or bleeding (thrombocytopenia) o Coagulation disorders that affect blood clotting ability o High fat levels in the blood (hyperlipidemia) o Fatty liver deposits (hepatomegaly) o Impaired liver function o Central nervous system symptoms (e.g., coma).

Frequency - Unknown:frequency cannot be estimated from the available data

• -allergic reactions;
• abnormal liver function test results;
• bile excretion problems (cholestasis);
• liver enlargement (hepatomegaly);
• liver diseases related to parenteral nutrition (see "Warnings and precautions" in section 2);
• jaundice;
• low platelet count (thrombocytopenia);
• high blood nitrogen levels (azotemia);
• increased liver enzyme activity;
• formation of small particles that can block blood vessels in the lungs (pulmonary embolism) leading to respiratory failure (respiratory failure).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store OLIMEL N5E, infusion emulsion

Store 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/RRRR). The expiry date refers to the last day of the given month.
Do not freeze.
Store in a protective packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What OLIMEL N5E, infusion emulsion contains

The active substances in each bag of the ready-to-use emulsion are: 8.2% (corresponding to 8.2 g/100 ml) L-amino acid solution (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (in the form of 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 (in the form of glucose monohydrate) with calcium.
Other ingredients of the medicine are:

What OLIMEL N5E, infusion emulsion looks like and contents of the pack

OLIMEL is an infusion emulsion supplied in a three-chamber bag. The first chamber contains the fat emulsion, the second chamber contains the amino acid solution with electrolytes, and the third chamber contains the glucose solution with calcium. The chambers are separated from each other by non-permeable welds.
Before administration, the contents of the individual chambers must be mixed by rolling the bag towards each other, starting from the top of the bag, until the welds open.
Appearance after mixing: a homogeneous emulsion with a milky appearance.
The three-chamber bag is a multi-layer plastic bag. The inner (contact) layer of the bag is compatible with the ingredients and permitted additives.
To prevent contact with oxygen in the air, the bag is packaged in a protective packaging that protects against oxygen access with an oxygen absorber sachet.

Pack sizes

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

Marketing authorization holder and manufacturer

Marketing authorization holder
Baxter Polska Sp. z o.o.
Kruczkowskiego Street 8
00-380 Warsaw
Manufacturer
BAXTER S.A.
Boulevard Rene Branquart 80
7860 Lessines, Belgium

This medicinal product is authorized in the Member States of the European Economic Area 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% with electrolytes
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

Date of last revision of the leaflet: 21.04.2020

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Information intended for healthcare professionals only:

Pharmacotherapeutic group: parenteral nutrition solutions/mixtures
ATC code: B05 BA10.

A. QUALITATIVE AND QUANTITATIVE COMPOSITION

OLIMEL has a three-chamber bag.
Each bag contains a glucose solution with calcium, a fat emulsion, and an amino acid solution with other electrolytes:

The composition of the ready-to-use emulsion after mixing the contents of the three chambers:

Excipients are:

Nutritional values of the ready-to-use emulsion, depending on the bag size:

B. DOSAGE AND ADMINISTRATION

Dosage

OLIMEL is not recommended for use in children under 2 years of age due to the inappropriate composition and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).
Do not exceed the recommended maximum daily dose. Due to the fixed composition of the multi-chamber bag, it may not be possible to meet all the nutritional needs of the patient at the same time. There may be clinical situations where patients require different amounts of nutrients than those contained in the bag with a fixed composition. In such a situation, any change in volume (dose) should take into account the impact on the dosing of all other nutrients in the OLIMEL medicine.
Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of the OLIMEL medicine, as well as on the energy and protein components additionally administered orally/enterally; therefore, the bag size should be chosen accordingly.
The average daily requirement is:

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

For the OLIMEL medicine, the maximum daily dose is determined based on the assumption of 40 ml of fluid/kg, which corresponds to 1.3 g of amino acids/kg, 4.6 g of glucose/kg, 1.6 g of fat/kg, 1.4 mmol of sodium/kg, and 1.2 mmol of potassium/kg. For a patient weighing 70 kg, this would correspond to 2800 ml of the OLIMEL medicine per day, which means the intake of 92 g of amino acids, 322 g of glucose, and 112 g of fat (i.e., 2408 non-protein kcal and a total of 2772 kcal).
Usually, the infusion rate should be gradually increased during the first hour and then adjusted according to the dose, daily volume of the administered medicine, and infusion duration.
The maximum infusion rate for the OLIMEL medicine is 2.1 ml/kg/h, which corresponds to 0.07 g of amino acids/kg/h, 0.24 g of glucose/kg/h, and 0.08 g of fat/kg/h.
Children over 2 years of age and adolescents
No studies have been conducted in the pediatric population.
Dosage is dependent on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of the OLIMEL medicine, as well as on the energy and protein components additionally administered orally/enterally; therefore, the bag size should be chosen accordingly.
In addition, daily requirements for fluids, nitrogen, and energy decrease with age. Two age groups have been considered: 2 to 11 years and 12 to 18 years.
For the OLIMEL N5E medicine in both age groups, the limiting factor for the daily dose is the magnesium concentration. In the 2 to 11-year-old age group, the limiting factors for the hourly infusion rate are the glucose and fat concentrations. In the 12 to 18-year-old age group, the limiting factor for the hourly infusion rate is the glucose concentration. The resulting intakes are presented below:

Usually, the infusion rate should be gradually increased during the first hour and then adjusted according to the dose, daily volume of the administered medicine, and infusion duration.
As a rule, in small children, it is recommended to start the infusion with a small daily dose and gradually increase it to the maximum dose (see above).

Method and duration of administration

For single use only.
After opening, the contents of the bag should be used immediately and not stored for subsequent infusions.
After mixing, a homogeneous mixture with a milky appearance is obtained.
Instructions for preparing and administering the infusion emulsion, see section 6.6 of the SmPC.
Due to the high osmolality of OLIMEL, it can only be administered into a central vein.
The recommended infusion duration for a parenteral nutrition bag is from 12 to 24 hours.
Treatment with parenteral nutrition can be continued for as long as the patient's clinical condition requires.

C. PHARMACEUTICAL INCOMPATIBILITIES

Do not add any medicinal products or substances to any of the bag's components or to the ready-to-use emulsion without prior confirmation of their compatibility and stability of the resulting product (especially the stability of the fat emulsion).
Incompatibilities may arise, for example, due to excessive acidity (low pH) or inappropriate calcium and magnesium ion content, 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, especially in the form of inorganic salts, may cause the formation of calcium phosphate precipitates.
OLIMEL contains calcium ions, which pose an additional risk of clot formation in blood or blood component preparations containing citrate as an anticoagulant/preservative.
Do not mix or administer ceftriaxone simultaneously with calcium-containing intravenous solutions, including the OLIMEL preparation, through the same infusion line (e.g., through a Y-connector) due to the risk of precipitation of calcium ceftriaxone (see sections 4.4 and 4.5 of the SmPC). Ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are exchanged or thoroughly flushed with physiological saline solution between infusions to avoid precipitate formation.
Due to the risk of precipitate formation, the OLIMEL medicine should not be administered through the same infusion line or added to ampicillin (antibiotic) or fosphenytoin (antiepileptic medicine).
Check compatibility with solutions administered simultaneously through the same infusion set, catheter, or cannula.
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

A review of the preparation stages for the administration of OLIMEL is presented in Figure 1.

Opening

Remove the protective bag.
Discard the oxygen absorber sachet.
Make sure the bag or welds are not damaged. Use only if the bag is undamaged and the welds are intact (i.e., the contents of the 3 chambers have not been mixed), the amino acid and glucose solutions are clear, colorless, or slightly yellow, practically free from visible particles, and the fat emulsion is homogeneous with a milky appearance.

Mixing the solutions and emulsion

Before breaking the welds, make sure the product is at room temperature.
Starting from the top of the bag (at the handle), roll the bag with both hands. The welds will disappear from the port side. Continue rolling the bag until the welds are broken halfway through their length.
Mix by turning the bag at least 3 times.
After mixing, the product has a homogeneous emulsion with a milky appearance.

Adding other components

The bag's capacity is sufficient to allow the addition of vitamins, electrolytes, and trace elements.
Any additives (including vitamins) should be introduced into the ready-to-use emulsion (after breaking the welds and mixing the contents of the 3 chambers).
Vitamins can also be added to the glucose chamber before preparing the ready-to-use emulsion (before breaking the welds and mixing the contents of the three chambers).
When introducing additional components into products containing electrolytes, consider the amount of electrolytes already present in the bag.
Additional components must be introduced by qualified personnel under aseptic conditions.
Electrolytes can be added to the OLIMEL medicine according to the following table:

Trace elements and vitamins:
Stability has been demonstrated after the addition of commercially available vitamin and trace element products (containing up to 1 mg of iron).
Compatibility with other additives is available on request.
When introducing additional components, ensure:

• aseptic conditions,
• preparation of the injection site on the bag,
• puncture of the injection site and injection of the additives using a syringe needle or a device for preparing the medicinal product,
• mixing of the bag contents with the additives.

Preparing the infusion

Ensure aseptic conditions.
Suspend the bag.
Remove the plastic protector from the administration port.
Firmly insert the infusion set needle into the administration port.
Figure 1. Stages of preparation for the administration of OLIMEL.

2. 3.

5. 6.

Administration

For single use only.
Administer the product only after breaking the welds separating the 3 chambers and mixing their contents.
Ensure that the ready-to-use emulsion for infusion does not separate into phases.
After opening the bag, the contents must be used immediately. Do not store
the opened bag for the next infusion. Do not reconnect partially used bags.
To avoid the possibility of air embolism caused by the presence of gas
contained in the first bag, do not connect bags in series.
Any unused product residues or waste and the entire infusion set should be
destroyed.
Extravasation
The site of catheter insertion should be regularly monitored for signs of extravasation.
In case of extravasation, administration of the preparation should be immediately discontinued, leaving the inserted catheter or cannula in place to immediately initiate therapeutic measures. If
possible, before removing the inserted catheter/cannula, aspiration of fluid through the
catheter/cannula should be performed to reduce the amount of fluid in the tissues.
Depending on the type of extravasated product (including products mixed with OLIMEL, if applicable) and the degree/extent of potential injury, appropriate specific measures should be taken. Treatment options may include non-pharmacological, pharmacological, and (or) surgical intervention. In case of large extravasation, a plastic surgeon should be consulted within 72 hours.
The extravasation site should be monitored at least every four hours during the first
24 hours, and then once a day.
Infusion should not be resumed in the same central vein.
Baxter and Olimel are trademarks of Baxter International Inc.