Olimel Peri N4e

Patient Information Leaflet: User Information

OLIMEL PERI N4E, infusion emulsion

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

• This leaflet should be kept for future reference, in case it needs to be read again.
• In case of any doubts, the doctor or nurse should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor or nurse should be informed. See section 4.

Table of Contents of the Leaflet

• 1. What OLIMEL PERI N4E infusion emulsion is and what it is used for
• 2. Important information before administering OLIMEL PERI N4E infusion emulsion
• 3. How to administer OLIMEL PERI N4E infusion emulsion
• 4. Possible side effects
• 5. How to store OLIMEL PERI N4E infusion emulsion
• 6. Package contents and other information

1. What OLIMEL PERI N4E infusion emulsion is and what it is used for

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

2. Important information before administering OLIMEL PERI N4E infusion emulsion

When not to use OLIMEL PERI N4E 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 the "Warnings and precautions" section 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 OLIMEL PERI N4E administration, the doctor or nurse should be consulted.
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 soy oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins.
The medicine OLIMEL PERI contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn products (see the "When not to use OLIMEL PERI N4E infusion emulsion" section 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, the doctor or nurse should be informed. They will decide on the appropriate action.
The antibiotic ceftriaxone should not be mixed or administered simultaneously with any calcium-containing solutions (including OLIMEL PERI) by intravenous drip.
These medicines should not be administered simultaneously, even through different infusion lines or injection sites.
However, OLIMEL PERI and ceftriaxone can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are replaced or thoroughly flushed with physiological saline solution between infusions to avoid precipitate formation (formation of calcium ceftriaxone particles).
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 inserting 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 prone to developing infections. 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 and needs to receive food through 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 adjust 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 removal (cholestasis), fat accumulation (fatty liver), fibrosis, possibly leading to liver failure, as well as gallbladder inflammation and gallstones. The causes of these disorders are believed 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;
• severe liver diseases;
• blood coagulation disorders;
• adrenal gland disorders (adrenal insufficiency). The adrenal glands are triangular glands located on top of the kidneys;
• heart failure;
• lung disease;
• fluid accumulation in the body (overhydration);
• insufficient fluid in the body (dehydration);
• untreated high blood sugar levels (diabetes);
• heart attack or shock caused by sudden heart failure;
• severe metabolic acidosis (too acidic blood);
• sepsis (blood infection);
• coma.

To check the effectiveness and safety of the medicine, the patient will undergo clinical and laboratory tests ordered by the doctor during treatment. If the medicine is administered for several weeks, the patient's blood will be regularly tested.
A decreased ability of the body to remove lipids contained in the administered preparation - may result in a so-called fat overload syndrome (see section 4 - "Possible side effects").
In case of pain, burning, or swelling at the infusion site or leakage of the infused fluid, the doctor or nurse should be informed.
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 OLIMEL PERI or administer a medicine to regulate blood sugar levels (insulin).
OLIMEL PERI can be administered through a tube (catheter) inserted into a vein in the patient's arm or into a large vein in the patient's chest (central vein).

Children and adolescents

In the case of use 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 amounts must be used.

OLIMEL PERI and other medicines

The doctor should be informed about all medicines currently being taken or used by the patient, as well as any medicines the patient plans to take or use.
Concomitant use of other medicines is usually not contraindicated. However, the doctor should be informed about all medicines taken recently, including those available without a prescription, to check their compatibility.
The doctor should be informed about the use or administration of:

• insulin,
• heparin.

OLIMEL PERI should not be administered simultaneously with blood through the same infusion set.
OLIMEL PERI 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, OLIMEL PERI should not be administered through the same infusion line or added to ampicillin (an antibiotic) or fosphenytoin (an antiepileptic drug).
The olive and soy oil present in the OLIMEL PERI preparation contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as coumarin. However, if the patient is taking anticoagulant medicines, they should inform their doctor.
The fats contained in the emulsion may interfere with the results of certain laboratory tests if the blood sample for testing is taken before the fats are removed from the patient's bloodstream (they are removed from the blood after 5 to 6 hours after fat administration).
OLIMEL PERI contains potassium. Particular caution should be exercised in patients taking diuretic medicines, ACE inhibitors, angiotensin II receptor antagonists (medicines used in hypertension), or immunosuppressive drugs. These types of medicines may cause an increase in blood potassium levels.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before administering this medicine.
There is limited experience with the use of OLIMEL PERI N4E in pregnant or breastfeeding women. If necessary, the use of OLIMEL PERI N4E during pregnancy and breastfeeding can be considered. OLIMEL PERI N4E should be administered to pregnant or breastfeeding women only after careful consideration.

Driving and operating machinery

Not applicable.

3. How to administer OLIMEL PERI N4E infusion emulsion

Dosage

OLIMEL PERI 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 vein in the arm or into a large vein in the patient's chest.
Before administration, OLIMEL PERI should be at room temperature.
OLIMEL PERI is for single use only.
The 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. This depends on the age, body weight, height, health status, and the body's ability to break down and utilize the components of OLIMEL PERI N4E.

Administration of a higher dose of OLIMEL PERI N4E infusion emulsion than recommended

In case 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 triglyceride levels in the blood. Administration of the infusion too quickly or in too large a volume may cause nausea, vomiting, chills, headache, flushing, excessive sweating, and electrolyte disturbances. In such a situation, the infusion should be stopped immediately.
In severe cases, the doctor may be forced to temporarily subject the patient to kidney dialysis to help the kidneys remove the excess medicine.
To prevent such situations, the doctor regularly monitors the patient's condition and checks blood parameters.
In case of doubts about the use of the medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any changes in the patient's condition during or after treatment, the doctor or nurse should be informed immediately.
Tests performed by the doctor during treatment 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.
During the use of OLIMEL PERI, the following side effects have been reported:
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, flushing, breathing difficulties;
• Infusion site reactions, which may lead to pain, irritation, swelling/edema, redness/warmth, 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 side effects have been reported:
Frequency - Very rare: may affect up to 1 in 10,000 people

• Fat overload syndrome, associated with a sudden deterioration in the patient's condition. The symptoms of fat overload syndrome usually resolve after discontinuation of the fat emulsion. o Fever o Decreased red blood cell count, which can cause paleness and be a 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, which affect the ability of blood to clot 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.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the doctor or nurse should be informed. 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
Al. Jerozolimskie 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 PERI N4E infusion emulsion

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the container and outer packaging (MM/RRRR). The expiry date refers to the last day of the month.
Do not freeze.
Store in protective packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What OLIMEL PERI N4E infusion emulsion contains

The active substances in each bag of the ready-to-use emulsion are: 6.3% (corresponding to 6.3 g/100 ml) L-amino acid solution (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), 15% (corresponding to 15 g/100 ml) fat emulsion (purified olive oil and purified soybean oil) and 18.75% (corresponding to 18.75 g/100 ml) glucose solution (as glucose monohydrate) with calcium.
Other ingredients of the medicine are:

What OLIMEL PERI N4E infusion emulsion looks like and what the pack contains

OLIMEL PERI is an infusion emulsion supplied in a triple-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 should be mixed by rolling the bag towards each other, starting from the top of the bag, until the welds open.

Appearance before mixing:

• The amino acid and glucose solutions are clear, colorless, or slightly yellow.
• The fat emulsion is homogeneous with a milky appearance.

Appearance after mixing:homogeneous emulsion with a milky appearance.
The triple-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 protective packaging that protects against oxygen ingress, with an oxygen absorber sachet.

Package sizes

1000 ml bag: 1 cardboard box with 6 bags
1500 ml bag: 1 cardboard box with 4 bags; 1 cardboard box with 5 bags
2000 ml bag: 1 cardboard box with 4 bags; 1 cardboard box with 5 bags
2500 ml bag: 1 cardboard box with 2 bags
1 bag of 1000 ml, 1500 ml, 2000 ml, and 2500 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Baxter Polska Sp. z o.o.
Ul. Kruczkowskiego 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, Bulgaria, Romania, Czech Republic, Belgium, Spain, Slovakia, Luxembourg, Slovenia, Hungary: PERIOLIMEL N4E
In some countries, it is registered under a different trade name, as described below:
Estonia, Poland, Lithuania, Latvia, Greece, Cyprus: OLIMEL PERI N4E
Netherlands: Olimel Perifeer N4E
Italy: OLIMEL Periferico N4E
Austria: PeriOLIMEL 2.5% with electrolytes
Germany: Olimel Peri 2.5% E
Denmark, Iceland, Sweden, Norway, Finland: Olimel Perifer N4E
United Kingdom, Ireland, Malta: Triomel Peripheral 4g/l nitrogen 700 kcal/l with electrolytes

Date of last revision of the leaflet: April 2025

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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 PERI is a triple-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, according to bag size:

B. DOSAGE AND ADMINISTRATION

Dosage

OLIMEL PERI 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).
The maximum daily dose should not be exceeded. Due to the fixed composition of the triple-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 PERI medicinal product.
Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL PERI, as well as the energy and protein components 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 OLIMEL PERI, the maximum daily dose has been determined based on the assumption of 40 ml of fluid/kg, which corresponds to 1 g of amino acids/kg, 3 g of glucose/kg, 1.2 g of fat/kg, 0.8 mmol of sodium/kg, and 0.6 mmol of potassium/kg. For a patient weighing 70 kg, this would correspond to 2800 ml of OLIMEL PERI per day, which is equivalent to 71 g of amino acids, 210 g of glucose, and 84 g of fat (i.e., 1680 non-protein kcal and a total of 1960 kcal).
Usually, the rate of administration should be increased gradually during the first hour, and then adjusted according to the dose, daily volume of the administered medicinal product, and infusion duration.
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 OLIMEL PERI, as well as the energy and protein components administered orally/enterally; therefore, the bag size should be chosen accordingly.
Additionally, 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 OLIMEL PERI N4E in both age groups, the limiting factor for the daily dose is the magnesium content. In the 2 to 11-year age group, the limiting factor for the hourly administration rate is the fat content. In the 12 to 18-year age group, the limiting factor for the hourly administration rate is the glucose content. The resulting intakes are presented below:

Usually, the rate of administration should be increased gradually during the first hour, and then adjusted according to the dose, daily volume of the administered medicinal product, and infusion duration.
Generally, 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).

Administration method and duration

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 preparation and administration of the infusion emulsion, see section 6.6 of the SmPC.
Due to the low osmolality of OLIMEL PERI, it can be administered into a peripheral or central vein.
The recommended infusion duration for a bag of parenteral nutrition 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

No other medicinal products or substances should be added 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 calcium and phosphate content ratio 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 PERI contains calcium ions, which pose an additional risk of clot formation in blood or blood component preparations containing citrate as an anticoagulant/preservative.
OLIMEL PERI should not be mixed or administered simultaneously with ceftriaxone through the same infusion line (e.g., through a Y-connector) due to the risk of calcium ceftriaxone salt precipitation (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 replaced or thoroughly flushed with physiological saline solution between infusions to avoid precipitate formation.
Due to the risk of precipitate formation, OLIMEL PERI should not be administered through the same infusion line or added to ampicillin or fosphenytoin.
Compatibility with solutions administered simultaneously through the same infusion set, catheter, or cannula should be checked.
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 steps for OLIMEL PERI before administration is presented in Figure 1.

Opening

Remove the protective bag.
Discard the oxygen absorber sachet.
Ensure that 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, and practically free from visible particles, and the fat emulsion is homogeneous with a milky appearance.

Mixing of solutions and emulsions

Before breaking the welds, ensure that 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 rotating the bag at least 3 times.
After mixing, the product has a homogeneous emulsion with a milky appearance.

Additional components

The bag volume 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 3 chambers).
When introducing additional components into products containing electrolytes, the amount of electrolytes already present in the bag should be taken into account.
Additional components must be introduced by qualified personnel under aseptic conditions.
Electrolytes can be added to OLIMEL PERI according to the following table:

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 additives is available on request.
When introducing additives, the final osmolality of the mixture should be measured before administration into a peripheral vein.
When introducing additional components, the following should be ensured:

• aseptic conditions are maintained,
• the injection site on the bag is prepared,
• the injection site is punctured and the additives are injected using a syringe needle or a device for preparing the medicinal product,
• the bag contents are mixed with the additives.

Preparation of Infusion

Control aseptic conditions.
Hang the bag.
Remove the plastic protector from the port for administering the medicinal product.
Definitely insert the needle of the infusion set into the port for administering the medicinal product.
Figure 1. Stages of preparation for administration of OLIMEL PERI.

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 infusion emulsion does not separate into phases.
After opening the bag, the contents must be used immediately. Do not store
an 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 in the first bag, do not connect bags in series.
Any unused product or waste and the entire infusion set should be
destroyed.
Extravasation
The site of catheter placement 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 procedures. If possible, before removing the inserted catheter/cannula, aspirate the fluid through the catheter/cannula to reduce the amount of fluid in the tissues. If extravasation occurs in a limb, the limb should be elevated.
Depending on the type of extravasated product (including products mixed with OLIMEL PERI, if applicable) and the degree/extent of potential injury, appropriate specific measures should be taken.
Options for therapeutic procedures may include non-pharmacological, pharmacological, and (or) surgical intervention. In case of large extravasation, a plastic surgeon should be consulted within 72 hours.
The site of extravasation 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 peripheral or central vein.
Baxter and Olimel Peri are trademarks of Baxter International Inc.