Olimel N9

Patient Information Leaflet: User Information

OLIMEL N9, infusion emulsion

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

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

Table of Contents of the Leaflet

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

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

OLIMEL is an infusion emulsion. The preparation is supplied in a triple-chamber bag.
In the first chamber, there is a glucose solution, in the second - a fat emulsion, and in the third -
a solution of amino acids.
OLIMEL is used for intravenous nutrition through a tube in adults and children over 2 years old, when oral nutrition is not appropriate.
OLIMEL should 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/corn products (see also "Warnings and precautions" below) or any of the other ingredients of this medicine (listed in section 6);
• if the use of certain amino acids causes an abnormal reaction in the patient's body;
• if the patient has a particularly high level of fats in the blood;
• if the patient has hyperglycemia (too high blood sugar level).

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 N9 administration, discuss it with your doctor or nurse.
Too rapid administration of total parenteral nutrition solutions may result in injury or death of the patient.
If unusual signs or symptoms of an allergic reaction occur (such as sweating, fever, chills, headache, skin rash, or breathing difficulties), the infusion should be stopped immediately. The medicine contains soybean oil and phospholipids from egg yolk. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins.
The OLIMEL medicine contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn products (see "When not to use OLIMEL N9 infusion emulsion" above).
Breathing difficulties may also be a sign that small particles have formed that can block blood vessels in the lungs (pulmonary embolism). If any breathing difficulties occur, the doctor or nurse should be informed. They will decide on the appropriate action.
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 when inserting, handling the catheter, and preparing the nutrition preparation (complete 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, vitamin, electrolyte, and mineral levels.
Before starting the infusion, the patient's water and electrolyte balance and metabolic disorders should be corrected. The doctor will monitor the patient during therapy and may change the dosage or prescribe additional nutritional preparations such as vitamins, electrolytes, and trace elements if necessary.
In patients receiving intravenous nutrition therapy, liver function disorders have been reported, including difficulty in removing bile (cholestasis), fat accumulation (fatty liver), fibrosis, which can lead to liver failure, as well as gallbladder inflammation and gallstones. The causes of these disorders are thought to be different in different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, they should consult a doctor to identify possible causes and therapeutic measures.
The doctor should be informed:

• about severe kidney diseases. The doctor should also be informed if the patient is undergoing dialysis (artificial kidney) or other blood purification methods;
• about severe liver diseases;
• about blood coagulation disorders;
• about adrenal insufficiency (adrenal gland failure). The adrenal glands are triangular glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about fluid accumulation in the body (overhydration);
• about insufficient fluid in the body (dehydration);
• about untreated high blood sugar levels (diabetes);
• about heart attack or shock caused by sudden heart failure;
• about severe metabolic acidosis (too acidic blood);
• about generalized infection (sepsis);
• about 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 reduced 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").
If pain, burning, or swelling occurs at the infusion site or if the infused fluid leaks during infusion, the doctor or nurse should be informed. The administration of the preparation will be stopped immediately and then resumed in a different vein.
If the blood sugar level increases excessively, the doctor should adjust the rate of administration of the OLIMEL preparation or administer a medicine that balances blood sugar levels (insulin).
OLIMEL can be administered through a tube (central venous catheter) inserted into a large vein in the patient's chest.

Children and adolescents

When used in children under 18 years of age, particular caution should be exercised to administer the correct dose of the preparation. Due to the increased susceptibility of children to the risk of infection, increased precautions should also be taken. Vitamin and trace element supplementation is always required. For children, pediatric compositions and quantities must be used.

OLIMEL and other medicines

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

• insulin,
• heparin.

Do not administer the OLIMEL medicine simultaneously with blood through the same infusion set.
Due to the risk of precipitate formation, the OLIMEL medicine should not be administered through the same infusion line or added to ampicillin (an antibiotic) or phenytoin (an antiepileptic drug).
The olive and soybean oil present in the OLIMEL preparation contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as coumarin. 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).

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 taking this medicine.
There is limited experience with the use of OLIMEL N9 in pregnant or breastfeeding women. If necessary, the use of OLIMEL N9 during pregnancy and breastfeeding can be considered. OLIMEL N9 should only be administered to pregnant or breastfeeding women after careful consideration.

Driving and using machines

Not applicable.

3. How to administer OLIMEL N9 infusion emulsion

Dosage

OLIMEL should only be used in adults and children over 2 years of age.
The medicine is an infusion emulsion administered through a tube (central venous catheter) into a large vein in the patient's chest.
Before administration, OLIMEL should be at room temperature.
OLIMEL 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, depending on the patient's age, body weight, height, health status, and ability to break down and utilize the components of the OLIMEL N9 preparation.

Administration of a higher dose of OLIMEL N9 infusion emulsion than recommended

In the event of administering too high a dose of the medicine or too rapid infusion, the contained amino acids may contribute to increased blood acidity and the occurrence of symptoms of hypervolemia (increased blood volume). Blood sugar levels and urine may increase, and hyperosmolar syndrome (excessive blood viscosity) may occur, and the fats contained in the emulsion may increase triglyceride levels in the blood. Taking the infused preparation too quickly or in excessive volume may cause nausea, vomiting, chills, headache, heat strokes, excessive sweating, and electrolyte disturbances. In such a situation, the infusion should be stopped immediately.
In some severe cases, to support the patient's kidneys in removing excess medicine, the doctor may be forced to temporarily perform kidney dialysis.
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, consult a doctor.

4. Possible side effects

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

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

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

• Hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, maculopapular, generalized rash), itching, heat strokes, and breathing difficulties;
• Infusion leakage into surrounding tissue (extravasation) may lead to pain, irritation, swelling/edema, redness/heating, skin necrosis, or blisters, inflammation, thickening, or contraction of the skin at the infusion site;
• Vomiting.

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

• Fat overload syndrome associated with sudden deterioration of 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 pale skin and be the cause of weakness or shortness of breath (anemia) o Low white blood cell count, which can increase the risk of infection (leukopenia) o Low platelet count, which can increase the risk of bruising and/or bleeding (thrombocytopenia) o Coagulation disorders that affect 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);
• enlarged liver (hepatomegaly);
• liver disease associated with parenteral nutrition (see "Warnings and precautions" in section 2);
• jaundice;
• decreased platelet count (thrombocytopenia);
• increased 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 you experience any side effects, including any not listed in this leaflet, you should inform your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 N9 infusion emulsion

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

6. Contents of the pack and other information

What OLIMEL N9 infusion emulsion contains

The active substances in each bag of the ready-to-use emulsion are: 14.2% (corresponding to 14.2 g/100 ml) L-amino acid solution (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (in the form of lysine acetate), methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, aspartic acid, glutamic acid), 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 (in the form of glucose monohydrate).
Other ingredients of the medicine are:

What OLIMEL N9 infusion emulsion looks like and what the pack contains

OLIMEL 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, and the third chamber contains the glucose solution.
The chambers are separated from each other by non-permeable welds. Before administration, the contents of the individual chambers must be mixed by rolling the bag towards each other, starting from the top of the bag, until the welds open.

Appearance 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 3-chamber bag is a multi-layer plastic bag. The inner (contact) layer of the bag is compatible with the ingredients and permitted additives.
To prevent contact with oxygen in the air, the bag is packaged in a protective package that protects against oxygen access with an oxygen absorber sachet.

Pack sizes

1000 ml bag: 1 cardboard box with 6 bags
1500 ml bag: 1 cardboard box with 4 bags
2000 ml bag: 1 cardboard box with 4 bags
1 bag with a capacity of 1000 ml, 1500 ml, and 2000 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, 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 nitrogen emulsion for infusion

Date of last revision of the leaflet: 21.04.2020 --------------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

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

A. QUALITATIVE AND QUANTITATIVE COMPOSITION

OLIMEL has a triple-chamber bag.
Each bag contains a glucose solution, a fat emulsion, and an amino acid solution:

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 sizes:

B. DOSAGE AND ADMINISTRATION

Dosage

OLIMEL is not recommended for use in children under 2 years of age due to the inappropriate composition and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).
Do not exceed the recommended maximum daily dose. Due to the constant 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 medicine.
Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of the OLIMEL product, as well as on the energy and protein components additionally administered orally/enterally, so the bag size should be chosen accordingly.
The average daily requirement is:

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

For the OLIMEL product, the maximum daily dose is determined based on the assumption of amino acids, 35 ml/kg corresponding to 2.0 g of amino acids/kg, 3.9 g of glucose/kg, and 1.4 g of fat/kg. For a patient weighing 70 kg, this would correspond to 2450 ml of the OLIMEL product per day, which means the intake of 140 g of amino acids, 270 g of glucose, and 98 g of fat (i.e., 2058 kcal of non-protein energy and a total of 2622 kcal).
Usually, the rate of administration should be increased gradually during the first hour, and then the infusion rate should be adjusted according to the dose, daily volume of the administered product, and infusion duration.
For the OLIMEL product, the maximum infusion rate is 1.8 ml/kg/h (except for IDPN, see below),
which corresponds to
0.10 g of amino acids/kg/h,
0.19 g of glucose/kg/h, and
0.07 g of fat/kg/h.
Patients receiving intradialytic parenteral nutrition (IDPN):Intradialytic parenteral nutrition is intended for patients who are not severely malnourished. The choice of the appropriate composition of the OLIMEL product and the volume to be used for IDPN should be based on the difference between spontaneous intake, as estimated, for example, in a dietary interview, and the recommended intake. Additionally, metabolic tolerance should be taken into account. In the case of OLIMEL N9 in patients receiving IDPN, the maximum infusion rate per hour is 3.6 ml/kg/h, which corresponds to 0.2 g/kg/h of amino acids, 0.40 g/kg/h of glucose, and 0.14 g/kg/h of fat administered over 4 hours.
Children over 2 years of age and adolescents
No studies have been conducted in the pediatric population.
Dosage is dependent on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of the OLIMEL product, as well as on the energy and protein components additionally administered orally/enterally, so the bag size should be chosen accordingly.
Additionally, daily fluid, nitrogen, and energy requirements decrease with age. Two age groups have been considered, from 2 to 11 years and from 12 to 18 years.
For the OLIMEL N9 product in both age groups, the limiting factor for the daily dose is the amino acid concentration. In the 2 to 11-year-old age group, the limiting factor for the hourly infusion rate is the glucose concentration. In the 12 to 18-year-old age group, the limiting factor for the hourly infusion rate is the amino acid concentration. The resulting intakes are presented below:

Usually, the infusion rate should be increased gradually during the first hour, and then adjusted according to the dose, daily volume of the administered product, and infusion duration.
For younger 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.
It is recommended to use the product immediately after opening and not to store it for subsequent infusions.
After mixing, a homogeneous mixture with a milky appearance is obtained.
Instructions for preparing and administering the infusion emulsion are provided in section 6.6 of the SmPC.
Due to the high osmolality of OLIMEL, it can only be administered into a central vein.
The recommended infusion duration for the parenteral nutrition bag is from 12 to 24 hours.
Treatment with parenteral nutrition can be continued for as long as the patient's clinical condition requires.

C. PHARMACEUTICAL INCOMPATIBILITIES

Do not add any medicinal products or substances to any of the bag's components or to the ready-to-use emulsion without prior confirmation of their compatibility and stability of the resulting product (especially the stability of the fat emulsion).
Incompatibilities may arise, for example, due to excessive acidity (low pH) or inappropriate calcium and magnesium ion content, which may destabilize the fat emulsion.
As with the preparation of other parenteral nutrition mixtures, the 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.
Due to the risk of precipitate formation, the OLIMEL medicine should not be administered through the same infusion line or added to ampicillin or phenytoin.
Check the compatibility with solutions administered simultaneously through the same infusion set, catheter, or cannula.
Due to the risk of pseudoagglutination, this product should not be administered before, during, or after blood transfusion through the same infusion set.

D. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION

Opening

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

Mixing the solutions and emulsion

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

Adding other components

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

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

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

Preparing the infusion

Maintain aseptic conditions.
Suspend the bag.
Remove the plastic protector from the administration port.
Firmly insert the infusion set needle into the administration port.
Figure 1. Steps to prepare OLIMEL for administration.

2. 3.

5. 6.

Administration

For single use only.
Administer the product only after breaking the welds separating the 3 chambers and mixing their contents.
Ensure that the ready-to-use emulsion does not separate into phases.
After opening the bag, the contents must be used immediately. Do not store the opened bag for subsequent infusions. 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 disposed of.
Extravasation
The site of catheter insertion should be regularly monitored for signs of extravasation.
In case of extravasation, stop the administration of the preparation immediately, leaving the inserted catheter or cannula in place to immediately initiate therapeutic measures. If possible, before removing the inserted catheter/cannula, aspirate the fluid through the catheter/cannula to reduce the amount of fluid in the tissues.
Depending on the type of extravasated product (including products mixed with the OLIMEL product, if applicable) and the degree/extent of potential injury, appropriate specific measures should be taken. Treatment options may include non-pharmacological, pharmacological, and/or surgical intervention. In case of large extravasation, consult a plastic surgeon within 72 hours.
Monitor the extravasation site at least every 4 hours during the first 24 hours, and then once a day.
Do not resume infusion in the same central vein.
Baxter and Olimel are trademarks of Baxter International Inc.