Olimel n12e

OLIMEL N12E, infusion emulsion
Please read the following information carefully before administering the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Table of contents

1. What OLIMEL N12E, infusion emulsion is and what it is used for
2. Important information before administration of OLIMEL N12E, infusion emulsion
3. How to use OLIMEL N12E, infusion emulsion
4. Possible side effects
5. How to store OLIMEL N12E, infusion emulsion
6. Contents of the pack and other information

1. What OLIMEL N12E, infusion emulsion is and what it is used for

OLIMEL N12E is an infusion emulsion. The medicine is supplied in a three-compartment bag.
The first compartment contains a glucose solution with calcium, the second compartment contains a fat emulsion, and the third compartment contains an amino acid solution with other electrolytes.
OLIMEL N12E is used for intravenous nutrition in adults and children above 2 years of age when oral nutrition is not suitable.
OLIMEL N12E may only be administered under medical supervision.

2. Important information before administering OLIMEL N12E, emulsion for infusion

When not to use OLIMEL N12E, 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 electrolyte (sodium, potassium, magnesium, calcium, and/or phosphorus).

In every case, the decision to administer the medicine will be made by the physician based on factors such as the patient's age, body weight, and overall health status, including results of diagnostic tests.

Warnings and precautions

Before starting administration of OLIMEL N12E, discuss this with the physician 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 must be stopped immediately. The medicine contains soybean oil and egg-derived phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soy proteins and peanut proteins have been observed.

OLIMEL N12E 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 N12E, emulsion for infusion" above).

Breathing difficulties may also indicate the formation of small particles blocking blood vessels in the lungs (pulmonary vascular precipitates). If any breathing difficulties occur, inform the physician or nurse immediately. They will decide on appropriate actions.

The antibiotic ceftriaxone must not be mixed or administered simultaneously with any calcium-containing solutions (including OLIMEL N12E) given by intravenous infusion.
These medicines must not be administered simultaneously even through different infusion lines or at different infusion sites.
However, OLIMEL N12E and ceftriaxone may be administered sequentially if the infusion lines are inserted at different sites, or if they are replaced or thoroughly flushed with physiological saline solution between infusions to prevent precipitation (formation of calcium ceftriaxone salt particles).

Certain medicines and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particularly high risk of infection or sepsis after placement of a tube (intravenous catheter) 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 into a vein) are, due to their underlying condition, at increased risk of developing infections. Maintaining sterile procedures (absence of microorganisms) during catheter placement, handling, and preparation of the nutrition solution (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. At the same time, the physician should closely monitor the patient to prevent sudden changes in fluid volume, and in concentrations of vitamins, electrolytes, and minerals.

Before starting the infusion, any disturbances in water-electrolyte balance and metabolic disorders should be corrected. The physician will monitor the patient during therapy and may adjust the dosage or, if appropriate, prescribe additional nutritional supplements such as vitamins, electrolytes, and trace elements.

Liver function disorders, including impaired bile excretion (cholestasis), fat accumulation (hepatic steatosis), fibrosis (possibly leading to liver failure), gallbladder inflammation, and gallstones, have been reported in patients receiving intravenous nutritional therapy. The causes of these disorders may 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). The adrenal glands are triangular-shaped glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about fluid retention in the body (overhydration);
• about insufficient body water (dehydration);
• about untreated high blood glucose levels (diabetes);
• about myocardial infarction or shock caused by sudden heart failure;
• about severe metabolic acidosis (excessively acidic blood);
• about generalized infection (sepsis);
• about coma.

To assess the effectiveness and safety of the medicine, the patient will undergo clinical and laboratory tests as ordered by the physician during administration. If the medicine 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 medicine may lead to the so-called "fat overload syndrome" (see section 4 – "Possible side effects").

If pain, burning, or swelling occurs at the infusion site during infusion, or if leakage of the infused fluid occurs, inform the physician or nurse immediately. Administration of the medicine will be stopped immediately and then resumed into another vein.

If blood glucose levels rise excessively, the physician should adjust the infusion rate of OLIMEL N12E or administer insulin to the patient to normalize blood sugar levels.

OLIMEL N12E may 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 is required to ensure correct dosing. Due to children's increased susceptibility to infection risk, enhanced precautions must also be taken. Vitamin and trace element supplementation is always required. Pediatric formulations and dosages must be used for children.

OLIMEL N12E 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 prescription, so their compatibility can be checked.

Inform the physician about the use or administration of:

• insulin,
• heparin.

OLIMEL N12E must not be administered simultaneously with blood through the same infusion set.
OLIMEL N12E contains calcium. It must 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 precipitation, OLIMEL N12E must not be administered through the same infusion line or mixed with ampicillin antibiotic or the anticonvulsant fosphenytoin.

The olive oil and soybean oil present in OLIMEL N12E contain vitamin K. This usually does not affect the action of anticoagulant medicines (blood thinners) such as coumarins. However, if the patient is taking anticoagulant medicines, they should inform the physician.

The lipids contained in the emulsion may interfere with the results of certain laboratory tests if blood samples are taken before the lipids have been cleared from the patient's circulation (lipids are cleared from the blood 5 to 6 hours after lipid administration).

OLIMEL N12E contains potassium. Particular caution is required in patients taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used for hypertension), or immunosuppressive medicines. These types of medicines may cause increased blood potassium levels.

Pregnancy, breastfeeding, and effects on fertility

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 N12E in pregnant or breastfeeding women. If necessary, administration of OLIMEL N12E during pregnancy and breastfeeding may be considered. OLIMEL N12E should be administered to pregnant or breastfeeding women only after careful consideration.

Fertility
Insufficient data available.

Driving and operating machinery
Not applicable.

3. How to use OLIMEL N12E, infusion emulsion

Dosage
OLIMEL N12E must be used only in adults and in children above the age of 2 years.
The medicine is an infusion emulsion administered through a catheter into a large vein in the patient's chest.
Before administration, OLIMEL N12E should be at room temperature.
OLIMEL N12E is intended for single use only.
Infusion of one bag usually lasts between 12 and 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 administration 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 N12E.

Administration of a higher than recommended dose of OLIMEL N12E, infusion emulsion
If too high a dose is administered or the infusion is given too rapidly, 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, and a hyperosmolarity syndrome (excessively high blood viscosity) may occur. The lipids contained in the emulsion may increase blood triglyceride levels. Administration of OLIMEL N12E at an excessive 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.
Occasionally, in severe cases, the physician may need to subject the patient to kidney dialysis for a period of time to assist the kidneys in eliminating the excess medicine.
To prevent such situations, the physician will regularly monitor the patient's condition and check blood parameters.
If you have any doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any changes in your health during or after treatment, you should immediately inform your doctor or nurse.
Tests performed by the doctor during administration of the medicine to the patient should minimize the risk of adverse reactions.
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 reactions have been reported during administration of OLIMEL:

Frequency — Common: may affect up to 1 in 10 people

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

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

• Hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, nodular, vesicular, macular, generalized rash), itching, hot flushes, breathing difficulties;
• Leakage of infusion into surrounding tissue (extravasation) which may lead to pain, irritation, swelling/edema, redness (erythema)/warming, tissue cell death (skin necrosis), or blisters/bulbous lesions, inflammation, thickening or tightness of the skin at the infusion site;
• Vomiting.

When using similar medicines for parenteral nutrition, the following adverse reactions 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 stopping the lipid emulsion infusion:
  • fever;
  • reduced number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anemia);
  • low number of white blood cells, which may increase the risk of infections (leukopenia);
  • low number of platelets, which may increase the risk of bruising and/or bleeding (thrombocytopenia);
  • coagulation disorders affecting the blood's ability to clot;
  • high blood fat levels (hyperlipidemia);
  • fatty deposits in the liver (hepatomegaly);
  • impaired liver function;
  • 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;
• Impaired bile excretion (cholestasis);
• Enlarged liver (hepatomegaly);
• Liver disorders associated with parenteral nutrition (see "Warnings and precautions" in section 2);
• Jaundice;
• Decreased platelet count (thrombocytopenia);
• Increased nitrogen levels in the blood (azotemia);
• Elevated liver enzyme activity;
• Formation of small particles which may cause blockage of blood vessels in the lungs (pulmonary vessel deposits), leading to pulmonary embolism and breathing difficulties (respiratory failure).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine OLIMEL N12E, infusion emulsion

Keep this medicine out of 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 packaging.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What OLIMEL N12E, infusion emulsion contains
The active substances in each bag of ready-to-use emulsion are: 14.2% (corresponding to 14.2 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),
17.5% (corresponding to 17.5 g/100 ml) fat emulsion (purified olive oil and purified soybean oil), and
27.5% (corresponding to 27.5 g/100 ml) glucose solution (as glucose monohydrate) with calcium.
The other ingredients are:

What OLIMEL N12E infusion emulsion looks like and what the packaging contains
OLIMEL N12E is an infusion emulsion supplied in a three-compartment bag. The first compartment contains a fat emulsion, the second compartment contains an amino acid solution with electrolytes, and the third compartment contains a glucose solution with calcium. The compartments are separated by non-permeable seals. Before administration, the contents of each compartment must be mixed by folding 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 fat emulsion is homogeneous with a milky appearance.

Appearance after mixing: homogeneous emulsion with a milky appearance.
The three-compartment bag is a multilayer plastic bag. 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 a protective packaging, shielding it from oxygen exposure, with an oxygen-absorbing sachet.

Pack sizes
650 ml bag: 1 cardboard box containing 10 bags; 1 cardboard box containing 5 bags
1000 ml bag: 1 cardboard box containing 6 bags
1500 ml bag: 1 cardboard box containing 4 bags; 1 cardboard box containing 5 bags
2000 ml bag: 1 cardboard box containing 4 bags; 1 cardboard box containing 5 bags
1 bag of 650 ml, 1000 ml, 1500 ml and 2000 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 Warsaw
Poland

Manufacturer
BAXTER S.A.
Boulevard René Branquart 80
7860 Lessines
Belgium

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Romania, Slovenia, Slovakia, Spain: OLIMEL N12E
Austria: ZentroOLIMEL 7,6 % mit Elektrolyten
Germany: Olimel 7,6 % E
Denmark, Iceland, Sweden, Norway, Finland, Poland, Portugal: Olimel N12E
Ireland, Malta, United Kingdom: TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes

Information intended exclusively for medical professionals:

A. QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL N12E is supplied as 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-to-use emulsion after mixing the contents of the three chambers:

The excipients are:

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

B. DOSAGE AND ADMINISTRATION
Dosage
OLIMEL N12E is not recommended for use in children under 2 years of age due to its inappropriate 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. Due to the fixed composition of the multi-chamber bag, it may not be possible to simultaneously meet all of the patient's nutritional requirements. 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 it will have on the dosing of all other nutrients in the medicinal product OLIMEL N12E. In such instances, healthcare professionals may consider adjusting the volume (dose) of the medicinal product OLIMEL N12E to meet increased requirements.

Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL N12E, as well as on additional energy components or proteins administered orally/enterally; therefore, the appropriate bag size should be selected accordingly.

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. Specific patient populations may require up to 0.4 g nitrogen/kg body weight (2.5 g amino acids/kg).
• 20 to 40 kcal/kg,
• 20 to 40 ml fluid/kg or 1 to 1.5 ml per kcal consumed.

For the product OLIMEL N12E, the maximum daily dose is defined based on amino acid intake: 26 ml/kg corresponds to 2.0 g amino acids/kg, 1.9 g glucose/kg, and 0.9 g lipids/kg. For a patient weighing 70 kg, this would correspond to 1820 ml of OLIMEL N12E per day, representing an intake of 138 g amino acids, 133 g glucose, and 64 g lipids (i.e., 1171 non-protein kcal and a total of 1723 kcal).

In continuous renal replacement therapy (CRRT): For the product OLIMEL N12E, the maximum daily dose is defined based on amino acid intake: 33 ml/kg corresponds to 2.5 g amino acids/kg, 2.4 g glucose/kg, and 1.2 g lipids/kg. For a patient weighing 70 kg, this would correspond to 2310 ml of OLIMEL N12E per day, representing an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1486 non-protein kcal and a total of 2187 kcal).

In patients with pathological obesity: The dose should be calculated based on ideal body weight (IBW). For the product OLIMEL N12E, the maximum daily dose is defined based on amino acid intake: 33 ml/kg IBW corresponds to 2.5 g amino acids/kg, 2.4 g glucose/kg, and 1.2 g lipids/kg. For a patient weighing 70 kg, this would correspond to 2310 ml of OLIMEL N12E per day, representing an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1486 non-protein kcal and a total of 2187 kcal).

Typically, the infusion rate must be gradually increased during the first hour, after which the infusion rate should be appropriately adjusted according to dose, daily volume of the medicinal product administered, and duration of infusion.
For the product OLIMEL N12E, the maximum infusion rate is 1.3 ml/kg/hour, corresponding to 0.10 g amino acids/kg/hour, 0.10 g glucose/kg/hour, and 0.05 g lipids/kg/hour.

Children over 2 years of age and adolescents
No studies have 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 N12E, 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 progressively decrease with age. Two age groups have been considered: 2 to 11 years and 12 to 18 years.
For the product OLIMEL N12E, in the 2 to 11-year age group, the limiting factors for the daily dose are the concentrations of amino acids and magnesium. In this age group, the hourly administration rate is limited by the concentration of amino acids. In the 12 to 18-year age group, the limiting factors for the daily dose are the concentrations of amino acids and magnesium. In this age group, the hourly administration rate is limited by the concentration of amino acids. The resulting intake recommendations are presented below:

The rate of administration should usually be gradually increased during the first hour, and then adjusted according to the dose administered, the daily volume of the medicinal product and the duration of the infusion.
In general, for small children, it is recommended to start the infusion with a low daily dose and gradually increase it to the maximum dosage (see above).
The maximum rate of administration in children aged 2 to 11 years is 2.6 ml/kg/hour, and in children aged 12 to 18 years is 1.6 ml/kg/hour.

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 for subsequent infusions.
After mixing, a homogeneous milky-appearing mixture is obtained.
Instructions for the preparation and use of infusion emulsions are described in section 6.6 of the SmPC.
Due to the high osmolarity of OLIMEL N12E, it must be administered exclusively via a central vein.
The recommended duration of infusion for the parenteral nutrition bag is 12 to 24 hours.
Parenteral nutrition treatment may be continued as long as clinically indicated by the patient's condition.

C. PHARMACEUTICAL INCOMPATIBILITIES
Do not add any medicinal products or substances to any of the bag 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 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 N12E contains calcium ions, posing 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 N12E, 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 sequentially if infusion lines are inserted at different sites or are replaced or thoroughly flushed with physiological saline solution between infusions to prevent precipitation.
Due to the risk of precipitate formation, OLIMEL N12E must 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 must 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 N12E for administration are illustrated in Figure 1.

Opening
Remove the protective bag.
Discard the sachet containing the oxygen absorber.
Ensure that the bag and seals are undamaged. Use only if the bag is intact and the seals are unbroken (i.e., the contents of the three chambers have not been mixed), the amino acid and glucose solutions are clear, colorless or slightly yellow, practically free of visible particles, and the fat emulsion is homogeneous and milky in appearance.

Mixing of solutions and emulsion
Before breaking the seals, ensure the product is at room temperature.
Starting from the top of the bag (at the handle), roll the bag with both hands. The seals will disappear starting from the port side. Continue rolling the bag 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 the addition of vitamins, electrolytes, and trace elements.
All additions (including vitamins) should be introduced into the ready-to-use emulsion (after breaking the seals and mixing the contents of the three chambers).
Vitamins may also be added to the chamber containing glucose before preparing the final emulsion (before breaking the seals and mixing the contents of the three chambers).
Additional components must be added by qualified personnel under aseptic conditions.
Electrolytes, inorganic/organic phosphates, commercially available multivitamin products (e.g., Cernevit), and products containing multiple trace elements (e.g., Nutryelit) may be added to OLIMEL N12E. The maximum total concentrations of the additional components listed in the table below are based on stability data and should not be interpreted as dosing recommendations. Supplementation should be based on the patient's clinical needs and should not exceed nutritional guidelines. When reaching the maximum total concentration, the amount of electrolytes already present in the bag must be taken into account.
Compatibility with products from different sources may vary, and healthcare professionals should perform appropriate checks when mixing OLIMEL N12E with other parenteral nutrition solutions.

When adding additional components, the following should be observed:

• Maintain aseptic conditions,
• Prepare the injection site on the bag,
• Puncture the injection site and inject the additional components using a syringe needle or a device for preparation of medicinal products,
• Mix the contents of the bag with the added components.

Shelf life after mixing
Chemical and physical stability in use has been demonstrated for 7 days when stored at 2°C to 8°C, followed by 48 hours of storage at a temperature not exceeding 30°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions prior to use, and storage should not exceed 24 hours at a temperature of 2°C to 8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.

Shelf life after addition of additional components
After addition of additional components, chemical and physical stability in use has been demonstrated for 7 days when stored at 2°C to 8°C, followed by 48 hours of storage at a temperature not exceeding 30°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions prior to use, and storage should not exceed 24 hours at a temperature of 2°C to 8°C, unless the addition of additional components was performed under controlled and validated aseptic conditions.

Preparation of infusion
Maintain aseptic conditions.
Hang the bag.
Remove the plastic protector from the medicinal product administration port.
Firmly insert the infusion set spike into the medicinal product administration port.

Figure 1. Steps in preparing OLIMEL product for administration

Administration
For single use only.
Administer the product only after breaking the seals separating the 3 chambers and mixing their contents.
Ensure that no phase separation occurs in the ready-to-use infusion emulsion.
After opening the bag, the contents must be used immediately. Do not store an opened bag for subsequent infusion. 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 product residues, waste, and the entire infusion set must be destroyed.

Extravasation
The catheter insertion site should be regularly monitored for signs of extravasation.
In case of extravasation, administration of the product must be stopped immediately, leaving the inserted catheter or cannula in place to allow immediate initiation of therapeutic measures. If possible, aspirate fluid through the catheter/cannula before removing it to reduce the amount of fluid in the tissues.
Depending on the type of extravasated product (including mixed product(s) with OLIMEL N12E, if applicable) and the extent/severity of potential injury, appropriate specific countermeasures should be taken. Therapeutic management options may include non-pharmacological treatment, pharmacological treatment, and (or) surgical intervention. In cases of significant extravasation, consultation with a plastic surgeon should occur within 72 hours.
The extravasation site should be monitored at least every four hours during the first 24 hours, and then once daily.
Infusion should not be resumed into the same central vein.

Baxter and Olimel are trademarks of Baxter International Inc.