Leaflet: information for the user

OlimelN9E emulsion for perfusion

Read this leaflet carefully before you receive this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• Ifyouexperienceside effects,consultyourdoctor ornurseeven if they are not listed in this leaflet. See section 4.

1.What is Olimel N9E and what it is used for

2.What you need to know before you receive Olimel N9E

3.How you will be given Olimel N9E

4.Possible side effects

5.Storage of Olimel N9E

6.Contents of the pack and additional information

Olimelis a perfusion emulsion. It is presented in a bag with 3 chambers

One chamber contains a glucose solution with calcium, the second contains a lipid emulsion, and the third contains an amino acid solution with other electrolytes.

Olimelis used to feed adults and children over two years of age through a tube in a vein when normal oral feeding is not possible

Olimelshould only be used under medical supervision.

OlimelN9Eshould not be administered:

• to premature neonates, infants, and children under two years of age
• if you are hypersensitive (allergic) to egg proteins, soybean proteins, peanut proteins, corn/maize products (see also the section “Warnings and precautions” below) or to any of the other components of this medication (listed in section 6).
• if your body has problems using certain amino acids.
• if you have especially high levels of fats in your blood
• if you have hyperglycemia (too much sugar in your blood)
• if you have an abnormally high level of any electrolyte (sodium, potassium, magnesium, calcium, and/or phosphorus) in your blood

Your doctor will decide whether or not to administer this medication based on factors such as your age, weight, and clinical condition, along with the results of all the tests performed.

Warnings and precautions

Consult your doctor or nurse before this medication is administered to you.

The administration of too rapid solutions of total parenteral nutrition (TPN) may cause injuries or death.

The infusion should be stopped immediately if any abnormal signs or symptoms of an allergic reaction develop (such as sweating, fever, chills, headache, skin rash, or difficulty breathing). This medication contains soybean oil and egg phospholipids. Soy and egg proteins can cause hypersensitivity reactions. Cross-reactions between soybean and peanut proteins have been observed.

Olimel contains corn-derived glucose, which may cause hypersensitivity reactions if you are allergic to corn or corn products (see section “Olimel N9E should not be administered” above).

Difficulty breathing may also be a sign that small particles have formed in the lungs that block blood vessels (pulmonary vascular precipitates). If you experience any difficulty breathing, inform your doctor or nurse. They will decide on the course of action.

The antibiotic called ceftriaxone should not be mixed or administered simultaneously with solutions that contain calcium (including Olimel) administered through a vein.

These medications should not be administered together, not even through different lines or sites of infusion.

However, Olimel and ceftriaxone can be administered sequentially one after the other if used through separate infusion lines in different locations, or if the infusion lines are replaced or thoroughly flushed with physiological saline solution between infusions to prevent the formation of precipitates (formation of ceftriaxone and calcium salt particles).

Certain medications and diseases may increase the risk of developing infections or sepsis (bacteria in the blood). There is a risk of infection or sepsis especially when a catheter (intravenous catheter) is placed in a vein. Your doctor will closely monitor you for signs of infection.

Patients requiring parenteral nutrition (administration of nutrients through a tube inserted into a vein) may be more prone to infections due to their medical condition. The use of "aseptic techniques" (germ-free) when placing and maintaining the catheter and preparing the nutritional formula (TPN) can reduce the risk of infection.

If you are severely malnourished to the point where you need to receive intravenous nutrition, your doctor will initiate treatment slowly. Additionally, your fluid, vitamin, electrolyte, and mineral levels will be monitored to avoid sudden changes.

Before starting the infusion, any metabolic disorders and your body's water and salt balance will be corrected. Your doctor will monitor your condition while you receive this medication and may adjust the dose or add other nutrients, such as vitamins, electrolytes, and oligoelements if deemed necessary.

Cases of liver disorders have been reported, including problems with bile elimination (cholestasis), fat storage (hepatic steatosis), fibrosis, which may lead to liver insufficiency, as well as cholecystitis and cholelithiasis in patients receiving intravenous nutritional treatment. It is believed that the cause of these disorders is due to multiple factors and may differ between patients. If you experience symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, consult your doctor to identify possible contributing factors and potential therapeutic and preventive measures.

Your doctor should be aware if you have:

- any severe kidney problems. You should also inform your doctor if you are receiving dialysis (artificial kidney) treatment or have another type of treatment to clean your blood

- any severe liver problems

- any coagulation problems with your blood

- abnormal functioning of your adrenal glands (adrenal insufficiency). Your adrenal glands are triangular in shape and are located above your kidneys

- heart failure

- lung disease

- water accumulation in your body (hyperhydration)

- insufficient water in your body (dehydration)

- high levels of sugar in your blood (diabetes mellitus) without treatment

- heart attack or shock due to sudden heart failure

- severe metabolic acidosis (blood too acidic)

- generalized infection (septicemia)

- coma

Your doctor will perform laboratory and clinical tests to check the effectiveness and safety of the administration of this medication. If you receive this medication for several weeks, your blood will be analyzed regularly.

The decrease in your body's ability to eliminate the fats contained in this medication may lead to a "fat overload syndrome" (see section 4 “Possible adverse effects”).

If you notice pain, burning, or swelling at the infusion site or infusion leaks, inform your doctor or nurse. The administration will be stopped immediately and resumed in another vein.

If your blood sugar levels become too high, your doctor will adjust the infusion rate of Olimel or administer medication to control your blood sugar levels (insulin).

Olimel can only be administered through a tube (catheter) connected to a large vein in your chest (central vein).

Children and adolescents

If your child is under 18 years old, special attention will be given to the correct dosage administration. Additional precautions will also be taken due to the increased sensitivity of children to the risk of infection. Vitamin and oligoelement supplementation is always necessary. Pediatric formulations should be used.

Use of Olimel with other medications

Inform your doctor if you are taking or using, have taken or used recently, or may need to take or use any other medication.

The simultaneous absorption of other medications is generally not a contraindication. If you are taking other medications, obtained with a prescription or over-the-counter, you should consult your doctor in advance to check if they are compatible.

Inform your doctor if you are taking or receiving any of the following medications:

- insulin

- heparin

Olimel should not be administered simultaneously with blood through the same infusion route.

Olimel contains calcium. It should not be administered together or through the same infusion route with the antibiotic ceftriaxona because they may form particles. If the same device is used to administer these medications sequentially, it should be thoroughly flushed.

Due to the risk of precipitation, Olimel should not be administered through the same infusion route or mixed with the antibiotic ampicilina or the antiepileptic fosphenitoína.

The soybean and olive oils present in Olimel contain vitamin K. This usually does not affect blood-thinning medications (anticoagulants) such as warfarin. However, if you are taking anticoagulants, you should inform your doctor.

The lipids contained in this emulsion may interfere with the results of certain laboratory tests if the blood sample is taken before the lipids have been eliminated from your bloodstream (usually after a period of 5 to 6 hours without receiving lipids).

Olimel contains potassium. You should be cautious in patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (blood pressure medications), or immunosuppressants. These classes of medications may increase potassium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before receiving this medication.

There are no adequate experiences with the use of Olimel in pregnant women or breastfeeding women. Olimel can be used during pregnancy and breastfeeding if necessary. Olimel should only be administered to pregnant women or breastfeeding women after careful consideration.

Driving and operating machinery

Not applicable.

Dose

Olimelshould only be administered to adults and children over two years old.

Olimelis an emulsion for infusion, meaning it will be administered through a tube (catheter) into a large vein in your chest.

Olimelmust be at room temperature before use.

Olimelis for single use only.

Dose – Adults

Your doctor will determine the infusion rate based on your needs and clinical condition.

The administration may continue for as long as necessary, based on your clinical condition.

Dose – Children over two years old and adolescents

Your doctor will decide on the dose and duration of administration, based on age, weight, height, clinical condition, and the body's ability to break down and utilize the ingredients inOLIMEL.

If you have been administered moreOlimelN9E than you should have

If the administered dose is too high or the infusion rate is too fast, the amino acid content may make your blood too acidicand signs of hypervolemia (increased circulating blood volume) may occur.Your blood glucose and urine levels may increase, a hyperosmolar syndrome (excessive blood viscosity) may develop, and the lipid content may increase your blood triglycerides. A rapid or excessive infusion ofOlimelmay cause nausea, vomiting, chills, headache, heat, excessive sweating (hyperhidrosis), and electrolyte imbalances. In this case, the infusion should be stopped immediately.

In severe cases, your doctor may need to perform temporary renal dialysis to help your kidneys eliminate excess product.

To prevent these cases, your doctor will regularly monitor your condition and analyze your blood parameters.

If you have any other questions about the use of this product, ask your doctor.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915.620.420

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If you notice that you do not feel as you did before, inform your doctor or nurse immediately.

The tests your doctor will perform while you are taking this medicine should minimize the risk of side effects.

If any abnormal sign or symptom of an allergic reaction develops, such as sweating, fever, chills, headache, skin rash, or difficulty breathing, you should stop the infusion immediately.

The following side effects have been described withOlimel:

Frequency – common: may affect up to 1 in 10 people

• Accelerated heart rate (tachycardia).
• Decreased appetite.
• Increased level of fats in the blood (hypertriglyceridemia).
• Abdominal pain.
• Diarrhea.
• Nausea.
• High blood pressure (hypertension).

Frequency - Unknown: cannot be estimated from available data

• Allergic reactions that include sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, macular, generalized rash), itching, hot flashes, difficulty breathing
• Leaks of the infusion into the surrounding tissue (extravasation) may cause pain at the infusion site, irritation, swelling/edema, redness/heat, skin cell death (skin necrosis) or blisters/blisters, inflammation, thickening or constriction of the skin.
• Vomiting.

The following side effects have been described with other similar parenteral nutrition products:

Frequency - Very rare: may affect up to 1 in 10,000 people

• Reduced ability to eliminate fats (fatty acid overload syndrome) associated with a sudden and severe worsening of the patient's medical condition. The following symptoms of fatty acid overload syndrome are normally reversible when the infusion of the lipid emulsion is stopped:
• • Fever.
  • Decreased red blood cells, which may cause pale skin and produce weakness or difficulty breathing (anemia).
  • Low white blood cell count, which may increase the risk of infection (leucopenia).
  • Low platelet count, which may increase the risk of bleeding and/or hemorrhage (thrombocytopenia).
  • Coagulation disorders that affect the blood's ability to clot
  • Elevated levels of fats in the blood (hyperlipidemia).
  • Fatty liver filtration (hepatomegaly).
  • Worsening of liver function.
  • Manifestations of the central nervous system (e.g. coma).

Frequency- Unknown: cannot be estimated from available data

• Allergic reactions.
• Problems with bile elimination (cholestasis).
• Abnormal blood test results for liver function.
• Enlarged liver (hepatomegaly).
• Diseases associated with parenteral nutrition (see "Warnings and precautions" in section2).
• Jaundice.
• Decreased platelet count (thrombocytopenia).
• Increased levels of nitrogen in the blood (azotemia).
• Increased liver enzymes.
• The formation ofsmall particlesthat maylead to theobstruction of blood vessels in the lungs(vascular pulmonary precipitates)resulting inpulmonary embolismand difficulty breathing(difficulty breathing).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medication out of sight and reachof children.

Do not usethis medicationafter the expiration date that appears on the packaging and outer packaging (MM/YYYY).The expiration date is the last day of the month indicated.

Do not freeze.

Store in the overwrap.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment..

Composition ofOlimelN9E

The active ingredients of each bag of the reconstituted emulsion are a solution of L-amino acids at 14.2% (corresponding to 14.2 g/100 ml of alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (as lysine acetate), methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, aspartic acid, and glutamic acid) with electrolytes (sodium, potassium, magnesium, phosphate, acetate, and chloride), a lipid emulsion at 20% (corresponding to 20 g/100 ml of refined olive oil and refined soybean oil), and a solution of glucose at 27.5% (corresponding to 27.5 g/100 ml as monohydrated glucose) with calcium.

The other components are:

Appearance ofOlimeland contents of the packaging

Olimelis a three-compartment emulsion for perfusion conditioned in a 3-compartment bag. One compartment contains a lipid emulsion, another a solution of amino acids with electrolytes, and the third a solution of glucose with calcium. These compartments are separated by non-permanent seals. Before administration, the contents of the compartments must be mixed by rotating the bag from the top of the bag until thesealsare open.

Appearance before reconstitution:

• The amino acid and glucose solutions are transparent, colorless, or slightly yellowish.
• The lipid emulsion is homogeneous and white.

Appearance after reconstitution: Homogeneous milk-like emulsion.

The tricompartimental bag is a plastic bag with multiple layers. The inner layer (contact) of the bag is designed to be compatible with the components and authorized additives.

To prevent contact with air oxygen, the bag is packaged in an outer bag that acts as an oxygen barrier, which contains a sticker with an oxygen absorbent.

Package sizes

1000 ml bag: 1 carton box with 6 bags

1500 ml bag: 1 carton box with 4 bags

2000 ml bag: 1 carton box with 4 bags

1 bag of 1000 ml, 1500 ml, and 2000 ml

Only some package sizes may be commercially available.

Marketing authorization holder

Baxter S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Responsible for manufacturing

Baxter S.A., Boulevard René Branquart, 80, 7860 Lessines, Belgium

This medicinal product is authorized in the member states of the European Economic Area with the following names:

France, Portugal, Estonia, Poland, Lithuania, Bulgaria, Romania, Latvia, Czech Republic, Belgium, Spain, Slovak Republic, Netherlands, Luxembourg, Slovenia, Italy, Greece, Cyprus: OLIMEL N9E

In some countries, it is registered with different names as described below:

Austria: ZentroOLIMEL 5,7% mit Elektrolyten

Germany: Olimel 5,7% E

Denmark, Iceland, Sweden, Norway, Finland: Olimel N9E

United Kingdom, Ireland, and Malta: Triomel 9g/l nitrogen 1070 kcal/l with electrolytes

Hungary: Olimel 9 g/l nitrogén elektrolitokkal emulziós infúzió

Last review date of this leafletApril 2020

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

Pharmacotherapeutic group: parenteral nutrition solutions / combinations

ATC code: B05 BA10.

A.Qualitative and quantitative composition

Olimelis presented in the form of a 3-compartment bag. Each bag contains a solution of glucose with calcium, a lipid emulsion, and a solution of amino acids with other electrolytes.

After mixing the contents of the three compartments, the composition of the reconstituted emulsion is indicated in the following table for each size of the bag.

(a) Blend of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to a ratio of essential fatty acids / total fatty acids of 20%

The excipients are:

The reconstituted emulsion provides the following for each size of bag:

aIncludes phospholipid calories from purified egg

bIncludes phosphate provided by the lipid emulsion

B.Dosage and administration

Dosage

Not recommended for use in children under 2 years, as neither the composition nor the volume is suitable (see sections 4.4, 5.1, and 5.2 of the SmPC).

The maximum daily dose mentioned below should not be exceeded. Due to the invariable composition of the multichamber bag, the ability to meet the patient's needs for all nutrients may not be possible. There may be clinical situations where the patient requires varying amounts of nutrients that differ from the composition of the bag. In this situation, any adjustment of volume (dose) should take into account the resulting effect on the dosing of the remaining nutrients of OLIMEL.

Adults

The dose depends on the patient's energy expenditure, clinical status, body weight, and ability to metabolize the components of Olimel, as well as any additional energy or protein administered orally or enterally. Therefore, the appropriate size of the bag should be chosen.

The average daily needs are:

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

For Olimel, the maximum daily dose is defined by the intake of amino acids, 35 ml/kg, corresponding to 2.0 g/kg of amino acids, 3.9 g/kg of glucose, 1.4 g/kg of lipids, 1.2 mmol/kg of sodium, and 1.1 mmol/kg of potassium. For a 70 kg patient, this would correspond to 2450 ml of Olimel per day, providing 140 g of amino acids, 270 g of glucose, and 98 g of lipids, i.e., 2058 kcal of non-protein calories and 2622 kcal of total calories.

Normally, the administration rate should be increased gradually during the first hour and then adjusted according to the dose being administered, the daily intake of volume, and the duration of perfusion.

For Olimel, the maximum perfusion rate is 1.8 ml/kg/hour, corresponding to 0.10 g/kg/hour of amino acids, 0.19 g/kg/hour of glucose, and 0.07 g/kg/hour of lipids.

Children over 2 years and adolescents

No studies have been conducted in the pediatric population.

The dose depends on the patient's energy expenditure, clinical status, body weight, and ability to metabolize the components of Olimel, as well as any additional energy or protein administered orally or enterally. Therefore, the appropriate size of the bag should be chosen.

Additionally, daily needs for liquid, nitrogen, and energy decrease continuously with age: Two age groups are considered, one between 2 and 11 years, and another between 12 and 18 years.

For Olimel N9E, in the 2 to 11-year age group, magnesium concentration is the limiting factor for daily dose, while glucose concentration is the limiting factor for hourly rate. In the 12 to 18-year age group, amino acid and magnesium concentrations are the limiting factors for daily dose, and amino acid concentration is the limiting factor for hourly rate.The resulting intakes are as follows:

a: Recommended values in the 2018 ESPGHAN/ESPEN/ESPR Guidelines

Normally, the administration rate should be increased gradually during the first hour and then adjusted according to the dose being administered, the daily intake of volume, and the duration of perfusion.

In general, in the case of small children, it is recommended to initiate perfusion with a reduced daily dose and gradually increase it to the maximum dose (see above).

Form and duration of administration

For single use only.

Once the bag is opened, the contents should be used immediately and not stored for subsequent perfusions.

The appearance of the mixture after reconstitution is a homogeneous milk-like emulsion.

For instructions on preparation and handling of the emulsion for perfusion, see section 6.6 of the SmPC.

Due to its high osmolarity, Olimel can only be administered through a central vein.

The recommended duration of perfusion of a nutrition bag is between 12 and 24 hours.

Treatment with parenteral nutrition can continue for as long as the patient's clinical condition requires.

C.Incompatibilities

No other medication or drug should be added to any of the bag components or to the reconstituted emulsion without first confirming the compatibility and stability of the resulting preparation (in particular, the stability of the lipid emulsion).

Incompatibilities may occur due, for example, to excessive acidity (low pH) or inadequate cationic divalent content (Ca2+ and Mg2+), which can destabilize the lipid emulsion.

As with any parenteral nutrition mixture, the proportions of calcium and phosphate should be taken into account. Excessive addition of calcium and phosphate, especially in the form of mineral salts, may cause the formation of calcium phosphate precipitates.

Olimel contains calcium ions, which poses an additional risk of coagulation in anticoagulated/blood preserved with citrate, or its components.

Olimel should not be mixed or administered with ceftriaxone through the same perfusion line (e.g., Y connector) due to the risk of precipitation of ceftriaxone with calcium salt (see sections 4.4 and 4.5 of the SmPC). Ceftriaxone and solutions containing calcium can be administered sequentially one after the other if separate perfusion lines are used, or if the lines are changed or flushed.

Due to the risk of precipitation, Olimel should not be administered through the same perfusion line or mixed with ampicillin or fosphenytoin.

Check compatibility with solutions administered simultaneously through the same administration equipment, catheter, or cannula.

Olimel should not be administered before, simultaneously, or after blood through the same equipment due to the risk of pseudoagglutination.

D.Special precautions for disposal and other manipulations

A general overview of the preparation steps for the administration of Olimel is provided in Table 1.

To open

Remove the outer protective bag.

Discard the oxygen absorbent sticker.

Confirm the integrity of the bag and the non-permanent seals. Use it only if the bag is not damaged, the non-permanent seals are intact (i.e., the contents of the three compartments have not been mixed), the amino acid and glucose solutions are transparent, colorless, or slightly yellowish, practically free of visible particles, and the lipid emulsion is a homogeneous liquid with a milky appearance.

Mixing the solutions and emulsion

Ensure the product is at room temperature when the non-permanent seals are broken.

Roll the bag manually, starting from the top of the bag (the hanging loop). The non-permanent seals will disappear from the side closest to the inlets. Continue rolling until the seals are open approximately halfway down their length.