Olimel n9

OLIMEL N9, emulsion for infusion
Please read the package leaflet carefully before administration, 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 the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

1. What OLIMEL N9, emulsion for infusion is and what it is used for
2. Important information before administration of OLIMEL N9, emulsion for infusion
3. How to use OLIMEL N9, emulsion for infusion
4. Possible side effects
5. How to store OLIMEL N9, emulsion for infusion
6. Contents of the pack and other information

1. What OLIMEL N9, emulsion for infusion is and what it is used for

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

2. Important information before administering OLIMEL N9, infusion emulsion

When not to use OLIMEL N9, infusion emulsion:

• in premature infants, newborns, and children under 2 years of age;
• if the patient is allergic to eggs, soy, peanut proteins, corn/products containing corn (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).

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

Warnings and precautions
Before starting OLIMEL N9, discuss this with the physician or nurse.
Too rapid administration of 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 product contains soybean oil and egg-derived phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soy proteins and peanuts have been observed.
OLIMEL contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn-containing products (see section "When not to use OLIMEL N9, infusion emulsion:" above).
Breathing difficulties may also indicate the formation of small particles blocking blood vessels in the lungs (pulmonary emboli). If any breathing difficulties occur, inform the physician or nurse immediately. They will decide on appropriate actions.
Certain medications and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). The risk of infection or sepsis is particularly high after insertion of a 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 inserted into a vein) are, due to their clinical condition, at higher risk of developing infections. Maintaining aseptic technique (absence of microorganisms) during catheter insertion, handling, and preparation of the nutritional formulation (total parenteral nutrition) may reduce the risk of infection.
If the patient is severely malnourished and requires intravenous feeding, the physician should initiate treatment slowly. At the same time, the physician should closely monitor the patient to prevent sudden changes in fluid volume, vitamin concentrations, electrolytes, and minerals.
Before starting the infusion, correct any fluid and electrolyte imbalances and metabolic disorders in the patient. The physician will monitor the patient during therapy and may adjust the dosage or, if deemed appropriate, prescribe additional nutritional supplements such as vitamins, electrolytes, and trace elements.
In patients receiving intravenous nutritional therapy, liver function disorders have been reported, including difficulties in bile elimination (cholestasis), fat accumulation (hepatic steatosis), fibrosis, possibly leading to liver failure, as well as cholecystitis and gallstones. The causes of these disorders are believed to vary among different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, or yellowing of the skin or eyes, consult the physician to identify possible causes, contributing factors, and potential therapeutic and 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 gland dysfunction (adrenal insufficiency). Adrenal glands are triangular-shaped glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about fluid accumulation in the body (overhydration);
• about insufficient body 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 eliminate lipids contained in the administered preparation may result in 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 preparation will be stopped immediately and then resumed via another vein.
If blood glucose levels increase excessively, the physician should adjust the infusion rate of OLIMEL or administer a medication to normalize blood sugar levels (insulin).
OLIMEL may be administered via a catheter inserted into a large vein in the patient's chest (central vein).

Children and adolescents
When used in children under 18 years of age, particular caution must be exercised to ensure correct dosing. Due to children's increased susceptibility to infection risk, enhanced precautions are required. Vitamin and trace element supplementation is always necessary. Pediatric formulations and dosages must be used for children.

OLIMEL and other medicines
Inform the physician about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use.
Concomitant use of other medicines is generally not contraindicated. However, the physician should be informed about all recently taken medicines, including those available without prescription, to verify compatibility.
Inform the physician about taking or receiving:

• insulin,
• heparin.

OLIMEL must not be administered simultaneously with blood through the same infusion set.
Due to the risk of precipitate formation, OLIMEL must not be administered through the same infusion line or added to ampicillin (an antibiotic) or fosphenytoin (an anticonvulsant).
The oil and soybean oil present in OLIMEL contain vitamin K. This usually does not affect the action of anticoagulant drugs (blood thinners) such as coumarin. However, if the patient is taking anticoagulant medications, 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 lipids have been cleared from the patient's circulation (lipids are cleared from the blood 5 to 6 hours after fat administration).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult the physician before administration of this medicine.
There is insufficient experience regarding the use of OLIMEL N9 in pregnant or breastfeeding women. If necessary, administration of OLIMEL N9 during pregnancy and breastfeeding may be considered. OLIMEL N9 should be administered to pregnant or breastfeeding women only after careful consideration.

Driving and operating machinery
Not applicable.

3. How to use OLIMEL N9, infusion emulsion

Dosage
OLIMEL must be used only in adults and in children above the age of 2 years.
The medicine is an infusion emulsion administered via a catheter into a large vein in the patient's chest.
Before administration, OLIMEL should be at room temperature.
OLIMEL is intended for single use only.
Infusion of one bag usually lasts 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 over two years of age and adolescents
The dose and duration of treatment will be determined by the physician, depending on age, body weight, height, health status, and the body's ability to metabolize and utilize the components of OLIMEL N9.

Administration of a higher than recommended dose of OLIMEL N9, infusion emulsion
If the patient receives too high a dose or the infusion is administered 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, hyperosmolarity syndrome (excessive blood viscosity) may develop, and the lipids contained in the emulsion may increase blood triglyceride levels. Administration of OLIMEL at too high a rate or in excessive volume may cause nausea, vomiting, chills, headache, hot flushes, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such cases, the infusion must be stopped immediately.

In severe cases, the physician may need to subject the patient to temporary kidney dialysis to assist the kidneys in eliminating the excess drug.
To prevent such situations, the physician regularly monitors the patient's condition and checks blood parameters.
If in doubt regarding the use of the medicine, consult the physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any changes in your health condition during or after treatment, you should immediately inform your doctor or nurse.
Medical examinations performed by the physician during the patient's treatment 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 the use of OLIMEL preparation:
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 arterial blood pressure (hypertension).

Frequency — Unknown: frequency cannot be determined from available data

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

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

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

Frequency — Unknown: frequency cannot be determined from available data

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store OLIMEL N9, emulsion for infusion

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

6. Package contents and other information

What OLIMEL N9, 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), 20% (corresponding to 20 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).
Other components of the medicinal product are:

What OLIMEL N9, infusion emulsion looks like and what the packaging contains
OLIMEL 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, and the third compartment contains a glucose solution. The compartments are separated by impermeable seals. Before administration, the contents of each compartment must be mixed by folding the bag towards itself starting from the upper part 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 3-compartment bag is a multilayer plastic pouch. The inner (contact) layer of the bag is compatible with the components and permitted additives.
To prevent contact with oxygen in the air, the bag is packed in an oxygen-protective packaging with an oxygen-absorbing sachet.

Packaging sizes
1000 ml bag: 1 cardboard box containing 6 bags
1500 ml bag: 1 cardboard box containing 4 bags
2000 ml bag: 1 cardboard box containing 4 bags
1 bag of 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 Rene Branquart 80
7860 Lessines, Belgium

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
France, Portugal, Estonia, Poland, Lithuania, Bulgaria, Romania, Latvia, Czech Republic, Belgium, Spain, Slovakia, Netherlands, Luxembourg, Slovenia, Italy, Greece, Cyprus: OLIMEL N9

In some countries it is registered under a different trade name as described below:
Austria: ZentroOLIMEL 5,7 %
Germany: Olimel 5,7%
Denmark, Iceland, Sweden, Norway, Finland: Olimel N9
United Kingdom, Ireland, Malta: Triomel 9g/l nitrogen 1070 kcal/l
Hungary: Olimel 9 g/l nitrogén emulziós infúzió

Information intended exclusively for healthcare professionals:

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

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 sizes:

B. DOSAGE AND ADMINISTRATION
Dosage
OLIMEL is not recommended for use in children under 2 years of age due to its unsuitable composition and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).
The maximum daily dose specified below should not be exceeded. Due to the fixed composition of the multi-chamber bag, complete coverage of all the patient's nutritional requirements may not be achievable. 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) must take into account its impact on the dosing of all other nutrients provided by the OLIMEL medicinal product.

Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL, as well as on additional energy or protein intake 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,
• 20 to 40 kcal/kg,
• 20 to 40 ml fluid/kg or 1 to 1.5 ml per kcal consumed.

For the OLIMEL product, the maximum daily dose is defined based on amino acid intake: 35 ml/kg corresponds to 2.0 g amino acids/kg, 3.9 g glucose/kg, and 1.4 g lipids/kg. For a 70 kg patient, this would correspond to 2450 ml of OLIMEL per day, resulting in an intake of 140 g amino acids, 270 g glucose, and 98 g lipids (i.e., 2058 kcal non-protein energy and a total of 2622 kcal).
Typically, the infusion rate must be gradually increased during the first hour, after which the infusion rate should be appropriately adjusted according to the required dose, daily volume of the medicinal product, and duration of infusion.
For OLIMEL, the maximum infusion rate is 1.8 ml/kg/hour (except for IDPN, see below), corresponding to 0.10 g amino acids/kg/hour, 0.19 g glucose/kg/hour, and 0.07 g lipids/kg/hour.

Patients receiving intradialytic parenteral nutrition (IDPN): Intradialytic parenteral nutrition is intended for patients who are not in a state of severe malnutrition. The selection of the appropriate OLIMEL formulation and volume for use in IDPN should be based on the difference between spontaneous intakes, as estimated, for example, by dietary interview, and recommended intake. In addition, metabolic tolerance should be taken into account. For OLIMEL N9 in patients receiving IDPN, the maximum infusion rate per hour is 3.6 ml/kg/hour, corresponding to 0.2 g/kg/hour amino acids, 0.40 g/kg/hour glucose, and 0.14 g/kg/hour lipids administered over 4 hours.

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, as well as on additional energy or protein intake administered orally/enterally; therefore, the appropriate bag size should be selected accordingly.
Furthermore, daily requirements for fluids, nitrogen, and energy continuously decrease with age. Two age groups have been considered: 2 to 11 years and 12 to 18 years.
For the OLIMEL N9 product in both age groups, the limiting factor for the daily dose is the concentration of amino acids. In the 2 to 11-year age group, the limiting factor for the hourly administration rate is the glucose concentration. In the 12 to 18-year age group, the limiting factor for the hourly administration rate is the amino acid concentration. The resulting intake values 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.
Generally, in small children, it is recommended to start infusion with a low daily dose and gradually increase it to the maximum dosage (see above).
Method and duration of administration
For single use only.
It is recommended to use the contents of the bag immediately after opening and not to store it for subsequent infusions.
After mixing, a homogeneous milky-appearing emulsion is obtained.
Instructions for the preparation and use of the infusion emulsion, see section 6.6 of the SmPC.
Due to its high osmolarity, OLIMEL must be administered only via a central vein.
The recommended duration of infusion for the parenteral nutrition bag is from 12 to 24 hours.
Parenteral nutrition treatment may be continued as long as clinically indicated 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 final 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 taken into account. Excessive addition of calcium and phosphate, especially in the form of inorganic salts, may lead to precipitation of calcium phosphate.
Due to the risk of precipitation, the medicinal product OLIMEL 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 verified.
Due to the risk of pseudoagglutination, this product should not be administered before, during or after blood transfusion through the same infusion set.
D. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION
A summary of the steps for preparing OLIMEL for administration is shown 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, colourless or slightly yellow, practically free from visible particles, and the fat emulsion is homogeneous and milky in appearance.
Mixing solutions and emulsion
Before breaking the seals, 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 seals will break progressively from the port side. Continue rolling the bag until the seals are broken along half their length.
Mix thoroughly by rotating the bag at least three times.
After mixing, the product forms a homogeneous milky-appearing emulsion.
Additional components
The bag capacity is sufficient to allow addition of vitamins, electrolytes and trace elements.
All additives (including vitamins) should be introduced into the final emulsion (after breaking the seals and mixing the contents of the three chambers).
Vitamins may also be added to the chamber containing glucose prior to preparing the final emulsion (before breaking the seals and mixing the contents of the three chambers).
When adding additional components to products containing electrolytes, the amount of electrolytes already present in the bag must be taken into account.
Additional components must be added by qualified personnel under aseptic conditions.
Electrolytes may be added to the OLIMEL product according to the table below:

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

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

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

2. 3.

5. 6.

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

Extravasation
The catheter insertion site should be regularly monitored for signs of extravasation.
In case of extravasation, administration must be stopped immediately, while leaving the inserted catheter or cannula in place to allow immediate initiation of 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 product(s) mixed with OLIMEL, if applicable) and the extent/severity of potential tissue injury, appropriate specific countermeasures should be taken. Therapeutic management options may include non-pharmacological, pharmacological, and/or surgical intervention. In cases of extensive extravasation, consultation with a plastic surgeon should be sought within 72 hours.
The extravasation site should be monitored at least every four hours during the first 24 hours, and then once daily.
Infusion should not be restarted into the same central vein.

Baxter and Olimel are trademarks of Baxter International Inc.