Leaflet: information for the user

Olimel N12 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, consult your doctor or nurse.
• Ifyouexperienceadverse effects,consultyourdoctor ornurseeven if the adverse effects are not listed in this leaflet. See section 4.

1.What Olimel N12 is and what it is used for

2.What you need to know before you receive Olimel N12

3.How you will be given Olimel N12

4.Adverse effects

5.Storage of Olimel N12

6.Contents of the pack and additional information

Olimel N12is a perfusion emulsion. It is presented in a bag with 3 chambers.

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

Olimel N12 is used to feed adults and children over two years of age through a tube in a vein when normal oral feeding is not possible.

Olimel N12 should only be used under medical supervision.

Olimel N12 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 especially high levels of fat in your blood.
• if you have hyperglycemia (too much sugar 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 N12 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 soy oil and egg phospholipids. Soy and egg proteins can cause hypersensitivity reactions. Cross-reactions between soybean and peanut proteins have been observed.

Olimel N12 contains corn-derived glucose, which may cause hypersensitivity reactions if you are allergic to corn or corn products (see section “Olimel N12 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.

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 should initiate treatment slowly. Additionally, you will be monitored to avoid sudden changes in your fluid, vitamin, electrolyte, and mineral levels.

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

Your doctor should know 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 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 experience pain, burning, or swelling at the infusion site or infusion leaks, inform your doctor or nurse. The infusion will be stopped immediately and restarted in another vein.

If your blood sugar levels become too high, your doctor will adjust the infusion rate of Olimel N12 or administer medication to control blood sugar levels (insulin).

Olimel N12 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 administration of the correct dose. 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 N12 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 N12 should not be administered simultaneously with blood through the same infusion route.

Due to the risk of precipitation, Olimel N12 should not be administered through the same infusion route or mixed with the antibiotic ampicillin or the antiepileptic fosphenytoin.

The soy and olive oils present in Olimel N12 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 the lipids).

Pregnancy and lactation

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

No adequate experiences have been reported with the use of Olimel N12 in pregnant women or breastfeeding women. Olimel N12 can be used during pregnancy and lactation if necessary. Olimel N12 should only be administered to pregnant women or breastfeeding women after careful consideration.

Fertility

No adequate data are available.

Driving and operating machinery

Not applicable.

Dose

Olimel N12 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 N12 must be at room temperature before use.

Olimel N12 is for single use only.

Dose – Adults

Your doctor will determine the 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 N12.

If You Have Been GivenToo Much Olimel N12

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 triglycerides in your blood.A rapid infusion or excessive volume of Olimel N12 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 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 with Olimel:

Frequent – frequent: may affect up to 1 in 10 people

• Accelerated heart rate (tachycardia).
• Decreased appetite.
• Increased levels 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.
• Leakage 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, 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).
  • Blood clotting 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).
• Liver diseases associated with parenteral nutrition (see "Warnings and precautions" in section 2).
• Jaundice.
• Decreased platelet count (thrombocytopenia).
• Increased 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 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 packagingafter(MM/YYYY).The expiration date is the last day of the month indicated.

Do not freeze.

Store in the overwrap.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medications. In this way, you will help protect the environment

Composition of Olimel N12

The active ingredients in 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), 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).

The other components are:

Appearance of Olimel N12 and contents of the package

Olimel N12 is a conditioned emulsion for perfusion in a 3-compartment bag. One compartment contains a lipid emulsion, another a solution of amino acids, and the third a solution of glucose. 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 authorized components and additives.

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

Packaging 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 packaging sizes may be marketed.

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:

Belgium, Czech Republic, France, Greece, Italy, Luxembourg, Netherlands, Slovenia, Spain: Olimel

Austria: ZentroOLIMEL 7.6%

Germany: Olimel

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

Ireland, Malta, United Kingdom: Triomel

Last review date of this leaflet: April 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 N12 is presented in the form of a 3-compartment bag.

Each bag contains a glucose solution, a lipid emulsion, and an amino acid solution

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 ratio of essential fatty acids to total fatty acids of 20%

The excipients are:

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

a) Includes calories from egg yolk phospholipids

b) Includes 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 Technical Dossier).

The maximum daily dose mentioned below should not be exceeded.

Due to the invariable composition of the multi-compartment bag, it may not be possible to simultaneously meet the patient's needs for all nutrients.

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 remaining nutrients of Olimel N12 should be taken into account.

In those situations, healthcare professionals may consider adjusting the volume (dose) of Olimel N12 in order to meet these greater needs.

In adults

The dose depends on the patient's energy expenditure, clinical status, body weight, and ability to metabolize the components of Olimel N12, 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:

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

For Olimel N12, 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.

For a 70 kg patient, this would correspond to 1820 ml of Olimel N12 per day, which would provide 138 g of amino acids, 133 g of glucose, and 64 g of lipids (i.e., 1171 non-protein calories and 1723 total calories).

In continuous renal replacement therapy (CRRT): For Olimel N12, 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, and 1.2 g/kg of lipids.

For a 70 kg patient, this would be equivalent to 2310 ml of Olimel N12 per day, which would result in an intake of 175 g of amino acids, 169 g of glucose, and 81 g of lipids (i.e., 1486 non-protein calories and 2187 total calories).

In obese patients: the dose should be calculated based on the ideal body weight.

For Olimel N12, 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, and 1.2 g/kg of lipids.

For a 70 kg patient, this would be equivalent to 2310 ml of Olimel N12 per day, which would result in an intake of 175 g of amino acids, 169 g of glucose, and 81 g of lipids (i.e., 1486 non-protein calories and 2187 total calories).

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

For Olimel N12, the maximum perfusion rate is 1.3 ml/kg/hour (except for NPID, see below), 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.

Patients with parenteral nutrition intradialytic (NPID): NPID is intended for malnourished patients who are not acute.

The selection of the appropriate formulation and volume of Olimel to use in NPID should be guided by the gap between estimated spontaneous intakes, for example, through dietary interview, and recommended intakes.

Additionally, the patient's metabolic tolerance should be taken into account.

For Olimel N12, in patients with NPID, the maximum perfusion rate per hour is 2.7 ml/kg/hour, corresponding to 0.2 g/kg/hour of amino acids, 0.2 g/kg/hour of glucose, and 0.09 g/kg/hour of lipids administered over 4 hours.

In 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 N12, as well as any additional energy or protein administered orally or enterally.

Therefore, the appropriate size of the bag should be chosen.

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

For Olimel N12, in the 2-11 year age group, the concentration of amino acids is the limiting factor for the daily dose and for the hourly rate. In the 12-18 year age group, the concentration of amino acids is the limiting factor for the daily dose and 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 based on the dose being administered, the daily intake of volume, and the duration of the 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).

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

Form and duration of administration

For single use only.

Once the bag is opened, it is recommended to use its contents immediately and not to store it for subsequent perfusions.

The appearance of the mixture after reconstitution is a homogeneous emulsion similar to milk.

For instructions on preparing and handling the emulsion for perfusion, see section 6.6 of the Technical Dossier.

Due to its high osmolarity, Olimel N12 can only be administered through a central vein.

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

The treatment with parenteral nutrition can continue for as long as the patient's clinical status requires.

C.Incompatibilities

No other medication or additive should be added to the bag or to the reconstituted emulsion without first confirming its compatibility and stability (in particular, the stability of the lipid emulsion).

Incompatibilities may occur due, for example, to excessive acidity (low pH) or inadequate levels of divalent cations (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, can cause the formation of calcium phosphate precipitates.

Due to the risk of precipitation, Olimel N12 should not be administered through the same perfusion route or mixed with ampicillin or fosphenytoin.

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

Olimel N12 should not be administered before, simultaneously, or after blood through the same equipment due to the risk of pseudoagglut