Leaflet: information for the user

Olimel N12E emulsion for infusion

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, ask your doctor or nurse.
• Ifyouexperienceside effects,consultyourdoctor ornurseeven if they are not listed in this leaflet. See section 4.

1.What Olimel N12E is and what it is used for

2.What you need to know before you receive Olimel N12E

3.How you will be given Olimel N12E

4.Possible side effects

5.Storage of Olimel N12E

6.Contents of the pack and additional information

Olimel N12Eis 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.

Olimel N12E is used to feed adults and children over 2 years of age through a tube in a vein when normal oral feeding is not possible

Olimel N12E should only be used under medical supervision.

Olimel N12E should not be administered:

• To premature neonates, infants, and children under two years of age
• If you are allergic to egg proteins, soybean proteins, peanut proteins, corn or corn products (see also the section “Warnings and precautions” below)
• If your body has problems using certain amino acids
• If you have an especially high level 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 Olimel N12E 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. The proteins from soy and egg can cause hypersensitivity reactions. Allergic cross-reactions have been observed between soybean proteins and peanut proteins.

Olimel N12E contains glucose derived from corn, which may cause hypersensitivity reactions if you are allergic to corn or corn products (see section “Olimel N12E should not be administered” above).

Difficulty breathing could 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 N12E) administered through a vein. Both medications should not be administered together, not even through different lines or sites of infusion.

However, Olimel N12E and ceftriaxone can be administered sequentially one after the other if used through separate infusion lines in different points, or if the infusion lines are replaced or thoroughly flushed with physiological saline solution between infusions to avoid the formation of precipitates (formation of ceftriaxone particles and calcium salt).

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 have a higher predisposition to infections due to their medical condition. The use of "aseptic techniques" (without germs) 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 feeding, your doctor will initiate treatment slowly. Additionally, you will be monitored to avoid sudden changes in your fluid levels, vitamins, electrolytes, and minerals.

Before starting the infusion, any metabolic disorders and the balance of water and salt in your body should be corrected. Your doctor will monitor your condition while you are receiving this medication and may change 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 (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, yellow discoloration of the skin or eyes, consult your doctor to identify possible contributing factors and therapeutic 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 blood clotting problems

- Abnormal functioning of the adrenal glands (adrenal insufficiency). The adrenal glands are triangular in shape and are located above the kidneys

- Heart failure

- Lung disease

- Excess water in the body (hyperhydration)

- Insufficient water in the body (dehydration)

- Excess sugar in the blood (diabetes mellitus) without treatment

- Heart attack or shock due to sudden heart failure

- Severe metabolic acidosis (blood too acidic)

- Generalized infection (septicemia)

- Coma

To check the effectiveness and safety of administration, your doctor will perform laboratory and clinical tests while you are receiving this medication. If you are receiving this medication for several weeks, your blood will be analyzed regularly.

The decrease in the 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 experience pain, burning, or swelling at the infusion site or infusion leaks, inform your doctor or nurse. The infusion 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 N12E or administer medication to control blood sugar levels (insulin).

Olimel N12E 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 dose 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 N12E 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 without one, 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 N12E should not be administered simultaneously with blood through the same infusion route.

Olimel N12E contains calcium. It should not be administered together or through the same infusion route with the antibiotic ceftriaxone 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 N12E should not be administered through the same infusion route or mixed with the antibiotic ampicillin or the antiepileptic fosphenytoin.

The olive and soybean oils present in Olimel N12E 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 N12E contains potassium. You should be particularly careful 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 N12E in pregnant women or breastfeeding women. Olimel N12E can be used during pregnancy and breastfeeding if necessary. Olimel N12E should only be administered to pregnant women or breastfeeding women after careful consideration.

Fertility

There are no available data.

Driving and operating machinery

Not applicable.

Dose

Olimel N12E should only be administered to adults and children over 2 years old.

It is an emulsion for infusion, meaning it is to be administered through a tube (catheter) into a vein in your chest.

Olimel N12E must be at room temperature before use.

Olimel N12E is for single use only.

Dose – Adults

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

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

Dose – Children over 2 years 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 of Olimel N12E.

If You Have Been GivenToo Much Olimel N12E

If the administered dose is too high or the infusion is too rapid, 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 lipid content may increase your blood triglycerides. A rapid or excessive infusion of Olimel N12E may 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 avoid 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, contact the Toxicology 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 with Olimel:

Frequent – frequent: 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.
• Elevated 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.
• The infusion leaks 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, skin thickening or compression.
• 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 usually 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.
  • Central nervous system manifestations (e.g. coma).

Frequency – Unknown: cannot be estimated from available data

• Allergic reactions.
• Abnormal blood test results for liver function.
• Problems with bile elimination (cholestasis).
• Enlarged liver (hepatomegaly).
• Diseases associated with parenteral nutrition (see "Warnings and precautions" in section 2).
• Jaundice.
• Decreased platelet count (thrombocytopenia).
• Elevated levels of nitrogen in the blood (azotemia).
• Increased liver enzymes.
• The formation of small particles that may lead to the obstruction of blood vessels in the lungs (pulmonary vascular precipitates) resulting in a pulmonary embolism and difficulty breathing (dyspnea).

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 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 packagingafter(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 of Olimel N12E

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), an emulsion of lipids at 17.5% (corresponding to 17.5 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 of Olimel N12E and contents of the package

Olimel N12E is a conditioned emulsion for perfusion 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 rolling the bag over itself from the top of the bag until the seals are open.

Appearance before reconstitution:

• The amino acid and glucose solutions are transparent, colorless, or slightly yellowish.
• The lipid emulsion is homogeneous and has a milky appearance.

Appearance after reconstitution: Homogeneous milky emulsion.

The tricompartimental bag is a plastic bag with multiple layers. The material of 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 overbag that acts as an oxygen barrier, which contains a sticker with an oxygen absorbent.

Package sizes

Bag of 650 ml: 1 carton box with 10 bags

Bag of 1000 ml: 1 carton box with 6 bags

Bag of 1500 ml: 1 carton box with 4 bags

Bag of 2000 ml: 1 carton box with 4 bags

1 bag of 650 ml, 1000 ml, 1500 ml, and 2000 ml

Only some package sizes may be marketed.

Marketing authorization holder

Baxter S.L.

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

Manufacturer

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:

Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Greece, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Romania, Slovenia, Slovakia, Spain: Olimel

Austria: ZentroOLIMEL 7.6% mit Elektrolyten

Germany: Olimel

Denmark, Iceland, Sweden, Norway, Finland, Poland, Portugal: Olimel

Ireland, Malta, United Kingdom: Triomel

Hungary: Olimel

Last revision 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

A.Qualitative and quantitative composition

Olimel N12E is 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 3 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 fatty acid essential/total fatty acids ratio of 20%

The excipients are:

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

b) Includes calories from egg phospholipids

c) Includes phosphate provided by the lipid emulsion

B.Dosage and administration

Dosage

It is not recommended to use Olimel N12E 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 multi-compartment bag, the ability to simultaneously meet the needs of all the patient's nutrients may not be possible.

There may be clinical situations in which the patient requires amounts of nutrients that vary from the composition of the bag.

In this situation, the impact of any volume adjustment (dose) and the resulting effect on the dosing of the rest of the nutrients of Olimel N12E should be taken into account.

In those situations, healthcare professionals may consider adjusting the volume (dose) of Olimel N12E in order to meet these greater needs.

Adults

The dose depends on the patient's energy expenditure, clinical status, body weight, and ability to metabolize the components of Olimel N12E, as well as the energy or protein administered orally or enterally.

The recommended daily doses 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 calorie expended.

For Olimel N12E, the maximum daily dose is defined by the intake of amino acids, 26 ml/kg, corresponding to 2.0 g/kg of amino acids, 1.9 g/kg of glucose, and 0.9 g/kg of lipids.

Continuous renal replacement therapy (CRRT): For Olimel N12E, the maximum daily dose is defined by the intake of amino acids, 33 ml/kg corresponding to 2.5 g/kg of amino acids, 2.4 g/kg of glucose, 1.2 g/kg of lipids.

Obese patients: the dose should be calculated based on the ideal body weight. For Olimel N12E, the maximum daily dose is defined by the intake of amino acids, 33 ml/kg of ideal body weight corresponds to 2.5 g/kg of amino acids, 2.4 g/kg of glucose, 1.2 g/kg of lipids.

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

The maximum perfusion rate is 1.3 ml/kg/hour, corresponding to 0.10 g/kg/hour of amino acids, 0.10 g/kg/hour of glucose, and 0.05 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 N12E, as well as the energy and protein administered orally or enterally.

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

For Olimel N12E, in the 2 to 11-year-old group, amino acid and magnesium concentrations are the limiting factors for the daily dose. In this age group, amino acid concentration is the limiting factor for the hourly rate. In the 12 to 18-year-old group, amino acid and magnesium concentrations are the limiting factors for the daily dose. In this age group, amino acid concentration is the limiting factor for the 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, daily intake volume, and perfusion duration.

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

The maximum perfusion rate is 2.6 ml/kg/hour in children aged 2 to 11 years and 1.6 ml/kg/hour in children aged 12 to 18 years.

Administration and duration

For single use only.

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