OLIMEL N12E EMULSION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Olimel N12E emulsion for infusion

Read all of this leaflet carefully before this medicine is administered to you, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Olimel N12E and what is it used for
2. What you need to know before Olimel N12E is administered to you
3. How Olimel N12E will be administered to you
4. Possible side effects
5. Storage of Olimel N12E
6. Package contents and further information

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

Olimel N12E is an emulsion for infusion. It comes 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 feeding by mouth is not possible.

Olimel N12E should only be used under medical supervision.

2. What you need to know before Olimel N12E is administered to you

Olimel N12E must not be administered:

• To premature neonates, babies, and children under 2 years of age.
• If you are allergic to egg proteins, soybean, peanut, corn/maize products (see also "Warnings and precautions" below) or to any of the other components of this medicine (listed in section 6).
• If your body has problems using certain amino acids.
• If you have especially high levels of fat in the blood.
• If you have hyperglycemia (too much sugar in the blood).
• If you have an abnormally high level of some electrolyte (sodium, potassium, magnesium, calcium, and/or phosphorus) in the blood.

In all cases, your doctor will decide whether you should be given this medicine based on factors such as your age, weight, and clinical condition, along with the results of all tests performed.

Warnings and precautions

Talk to your doctor or nurse before Olimel N12E is administered to you.

Too rapid administration of total parenteral nutrition (TPN) solutions may cause injury or death.

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

Olimel N12E contains glucose derived from maize, which may cause hypersensitivity reactions if you are allergic to maize or maize products (see "Olimel N12E must not be administered" above).

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

The antibiotic called ceftriaxone must not be mixed or administered simultaneously with solutions containing calcium (including Olimel N12E) given by infusion into a vein. Both medicines must not be administered together, even through different lines or infusion sites.

However, Olimel N12E and ceftriaxone may be administered sequentially, one after the other, if infusion lines are used at 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 and calcium salt particles).

Certain medicines 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 tube (intravenous catheter) is placed in a vein. Your doctor will closely monitor you for signs of infection. Patients who require 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 of needing intravenous feeding, your doctor will start 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 water and salt balance in your body must be corrected. Your doctor will monitor your condition while you are being administered this medicine and may change the dose or add other nutrients, such as vitamins, electrolytes, and trace elements, if deemed necessary.

Cases of liver disorders, including problems with bile elimination (cholestasis), fat storage (hepatic steatosis), fibrosis, which may lead to liver failure, as well as cholecystitis and cholelithiasis, have been reported 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 causative and contributing factors and possible therapeutic and preventive measures.

Your doctor should be aware if you have:

• any severe kidney problem. You should also inform your doctor if you are receiving dialysis treatment (artificial kidney) or if you have any other type of treatment to clean the blood.
• any severe liver problem.
• any blood coagulation problem.
• 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.
• fluid accumulation in the body (hyperhydration).
• insufficient water in the body (dehydration).
• excess sugar in the blood (diabetes mellitus) without treatment for it.
• 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 being administered this medicine. If you are administered this medicine for several weeks, your blood will be regularly analyzed.

A decrease in the body's ability to eliminate the fats contained in this medicine may lead to a "fat overload syndrome" (see section 4 "Possible side effects").

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

If your blood sugar levels rise too high, your doctor will adjust the rate of administration of Olimel N12E or provide you with 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 of age, special attention will be paid to the administration of the correct dose. Additional precautions will also be taken due to the greater sensitivity of children to the risk of infection. Supplementation with vitamins and trace elements is always necessary. Pediatric formulations should be used.

Use of Olimel N12E with other medicines

Tell your doctor if you are taking or using, have recently taken or used, or might take or use any other medicine.

Simultaneous absorption of other medicines is generally not a contraindication. If you are taking other medicines, obtained with or without a prescription, you should consult your doctor in advance so that they can check if they are compatible.

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

• insulin.
• heparin.

Olimel N12E must not be administered simultaneously with blood through the same infusion line.

Olimel N12E contains calcium. It must not be administered together or through the same line with the antibiotic ceftriaxone, as particles may form. If the same device is used to administer these medicines sequentially, it must be thoroughly flushed.

Due to the risk of precipitation, Olimel N12E must not be administered through the same infusion line 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 medicines (anticoagulants) such as coumarin. 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 they have been eliminated from your bloodstream (usually after a period of 5 to 6 hours without receiving lipids).

Olimel N12E contains potassium. Special care should be taken in patients who are taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (medicines for high blood pressure), or immunosuppressants. These classes of medicines may increase potassium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before this medicine is administered to you.

There is no adequate experience with the use of Olimel N12E in pregnant or breastfeeding women. Olimel N12E may be used during pregnancy and breastfeeding if necessary. Olimel N12E should only be administered to pregnant or breastfeeding women after careful consideration.

Fertility

No adequate data are available.

Driving and using machines

Not applicable.

3. How Olimel N12E will be administered to you

Dose

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

This is an emulsion for infusion, i.e., for administration through a tube (catheter) into a vein in your chest.

Olimel N12E should 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, depending on your clinical condition.

Dose – Children over 2 years of age and adolescents

The doctor will decide on the dose and the duration for which the medicine will be administered, based on age, weight, height, clinical condition, and the body's ability to break down and use the ingredients of Olimel N12E.

If you have been administered too much Olimel N12E

If the dose administered is too high or the infusion is too rapid, the amino acid content may make your blood too acidic, and signs of hypervolemia (increased circulating blood volume) may occur. Your blood and urine glucose levels may rise, a hyperosmolar syndrome may develop, and the lipid content may increase your blood triglycerides. Administration of an infusion that is too rapid or a volume that is too high may cause nausea, vomiting, chills, headache, fever, excessive sweating (hyperhidrosis), and electrolyte disturbances. In this case, the infusion should be stopped immediately.

In some 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 further questions about the use of this product, ask your doctor.

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

4. Possible side effects

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

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

If any abnormal signs or symptoms of an allergic reaction, such as sweating, fever, chills, headache, skin rash, or difficulty breathing, develop, the infusion should be stopped immediately.

The following side effects have been reported with Olimel:

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

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

Frequency - unknown: cannot be estimated from available data

• Hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, macular, generalized rash), itching, flushing, difficulty breathing.
• Infusion site reactions, including pain, irritation, swelling/edema, redness (erythema)/heat, cell death (necrosis of the skin), or blisters/vesicles, inflammation, thickening, or oppression of the skin.
• Vomiting.

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

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

• Reduced ability to eliminate lipids (fat overload syndrome) associated with a sudden and severe worsening of the patient's medical condition. The following symptoms of fat overload syndrome are usually reversible when the lipid emulsion infusion is stopped:
• • Fever.
  • Decreased red blood cells, which can cause pale skin and weakness or difficulty breathing (anemia).
  • Low white blood cell count, which can increase the risk of infection (leucopenia).
  • Low platelet count, which can increase the risk of bruising and/or bleeding (thrombocytopenia).
  • Blood coagulation disorders affecting the blood's ability to clot.
  • High levels of fat in the blood (hyperlipidemia).
  • Fatty infiltration of the liver (hepatomegaly).
  • Worsening of liver function.
  • Central nervous system manifestations (e.g., coma).

Frequency - unknown: cannot be estimated from available data

• Allergic reactions.
• Abnormal blood tests for liver function.
• Problems with bile elimination (cholestasis).
• Increased liver size (hepatomegaly).
• 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.
• Formation of small particles that can lead to blockage of blood vessels in the lungs (pulmonary vascular precipitates), resulting in pulmonary vascular embolism and difficulty breathing (respiratory distress).

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olimel N12E

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and outer packaging after (MM/YYYY). The expiry date is the last day of the month indicated.

Do not freeze.

Store in the overbag.

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. Container Contents and Additional Information

Olimel N12E Composition

The active ingredients of each bag of the reconstituted emulsion are a 14.2% L-amino acid solution (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, chloride), a 17.5% lipid emulsion (corresponding to 17.5 g/100 ml of refined olive oil and refined soybean oil) and a 27.5% glucose solution (corresponding to 27.5 g/100 ml as glucose monohydrate) with calcium.

The other components are:

Appearance of Olimel N12E and Container Contents

Olimel N12E is an emulsion for infusion packaged in a 3-compartment bag. One compartment contains a lipid emulsion, another an amino acid solution with electrolytes, and the third a glucose solution 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 clear, colorless, or slightly yellowish.
• The lipid emulsion is homogeneous and has a milky appearance.

Appearance after reconstitution: Homogeneous milky emulsion.

The 3-compartment 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 avoid contact with oxygen in the air, the bag is packaged in an outer bag that acts as an oxygen barrier, which contains a sachet with an oxygen absorber.

Container Sizes

650 ml bag: 1 cardboard box with 10 bags

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

Only some container 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 under the following names:

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

Austria:

Germany:

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

Ireland, Malta, United Kingdom:

Hungary:

Date of Last Revision of this ProspectusApril 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

• Qualitative and quantitative composition

Olimel N12E is presented in the form of a 3-compartment bag. Each bag contains a glucose solution with calcium, a lipid emulsion, and an amino acid solution 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 bag size.

(a) Mixture 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 nutritional contributions for each bag size:

b Includes calories from purified egg phospholipids

c Includes phosphate provided by the lipid emulsion

• Dosage and Administration

Dosage

Olimel N12E is not recommended for use in children under 2 years of age, as neither the composition nor the volume is suitable (see sections 4.4, 5.1, and 5.2 of the Technical Data Sheet).

The maximum daily dose mentioned below should not be exceeded. Due to the invariant composition of the multicomponent bag, the ability to simultaneously meet all the patient's nutritional needs may not be possible. There may be clinical situations where 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 other nutrients of Olimel N12E should be taken into account. In these situations, healthcare professionals may consider adjusting the volume (dose) of Olimel N12E 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 N12E, as well as any additional energy or proteins administered orally or enterally. Therefore, the appropriate bag size should be chosen.

The average daily needs are:

• 0.16 to 0.35 g of nitrogen/kg of body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and level of catabolic stress. Special populations may require up to 0.4 g of nitrogen/kg of body weight (2.5 g of amino acids/kg).
• 20 to 40 kcal/kg.
• 20 to 40 ml of fluid/kg, or 1 to 1.5 ml per kcal 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. For a 70 kg patient, this would be equivalent to 1820 ml of Olimel N12E per day, which would provide 138 g of amino acids, 133 g of glucose, and 64 g of lipids (i.e., 1171 non-protein kcal and 1723 total kcal).

In 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. For a 70 kg patient, this would be equivalent to 2310 ml of Olimel N12E 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 kcal and 2187 total kcal).

Patients with Morbid Obesity: 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 corresponding to 2.5 g/kg of amino acids, 2.4 g/kg of glucose, 1.2 g/kg of lipids. For a 70 kg patient, this would be equivalent to 2310 ml of Olimel N12E 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 kcal and 2187 total kcal).

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

For Olimel N12E, the maximum infusion 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.

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, weight, and ability to metabolize the components of Olimel N12E, as well as any additional energy and proteins administered orally or enterally. Therefore, the appropriate bag size should be chosen.

In addition, daily fluid, 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 N12E, in the 2 to 11-year-old group, the concentrations of amino acids and magnesium are the limiting factors for the daily dose. In this age group, the concentration of amino acids is the limiting factor for the hourly rate. In the 12 to 18-year-old group, the concentrations of amino acids and magnesium are the limiting factors for the daily dose. In this age group, the concentration of amino acids is the limiting factor for the hourly rate. The resulting intakes are as follows:

a: Values recommended in the 2018 ESPGHAN/ESPEN/ESPR Guidelines

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

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

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

Form and Duration of Administration

For single use.

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

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

For instructions on the preparation and handling of the emulsion for infusion, see section 6.6 of the Technical Data Sheet.

Due to its high osmolality, Olimel N12E can only be administered through a central vein.

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

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

• Incompatibilities

No other medication or component should be added to the bag or the reconstituted emulsion without first confirming the compatibility and stability of the resulting preparation (in concentrations and conditions similar to those found in clinical use).

This is the stability of the lipid emulsion).

Incompatibilities may occur due to, for example, excessive acidity (low pH) or inadequate content 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

Olimel N12E contains calcium ions, which poses an additional risk of coagulation in anticoagulated/preserved blood with citrate, or its components.

Ceftriaxone must not be mixed or administered with intravenous solutions containing calcium, including Olimel N12E, through the same infusion line (e.g. Y connector) due to the risk of ceftriaxone precipitation with calcium salt (see sections 4.4 and 4.5 of the Technical Sheet). Ceftriaxone and calcium-containing solutions can be administered sequentially one after the other if infusion lines are used at different points, or if the infusion lines are replaced or if they are thoroughly flushed between infusions with physiological saline solution to avoid the formation of precipitates

Due to the risk of precipitation, Olimel N12E should not be administered through the same infusion line or mixed with ampicillin or fosphenytoin.

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

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

• Special precautions for disposal and other handling

In Table 1, an overview of the preparation steps for the administration of Olimel N12E is provided.

To open

Remove the protective overbag.

Discard the oxygen absorber packet.

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), if the amino acid solution and the glucose solution are clear, colorless or slightly yellowish, practically free of visible particles and if the lipid emulsion is a homogeneous liquid with a milky appearance.

Mixing of solutions and emulsion

Make sure the product is at room temperature when breaking the non-permanent seals.

Manually roll the bag over itself, starting from the top of the bag (hanger end). The non-permanent seals will disappear from the side close to the entrances. Continue rolling until the seals are open approximately halfway through their length.

Mix the bag by inverting it at least 3 times.

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

Additions

The bag has sufficient capacity for vitamins, electrolytes, and trace elements to be added.

Any addition (including vitamins) must be made to the reconstituted mixture (after breaking the non-permanent seals and mixing the contents of the three compartments).

Vitamins can also be added to the glucose compartment before reconstituting the mixture (before breaking the non-permanent seals and mixing the contents of the three compartments).

Additions must be carried out by qualified personnel under aseptic conditions.

The formulation of Olimel N12E can be supplemented with electrolytes, inorganic/organic phosphate and with commercially available multivitamin preparations (such as Cernevit) and multiple trace element products (such as Nutryelt). The maximum total levels for the additions listed in the table below have been demonstrated with stability data and should not be considered dosage recommendations. The addition should be dictated by the patient's clinical needs and should not exceed nutritional guidelines. The electrolytes already present in the bag should be taken into account when reaching the maximum total level.

Compatibility may vary between products from different sources, so healthcare professionals are recommended to perform the necessary checks when mixing Olimel N12 with other parenteral solutions.

Possible supplements for 1000 ml of Olimel N12E (for pediatric patients)

• Includes phosphate provided by the lipid emulsion.

• Pi inorganic phosphate; Po organic phosphate

• For all formats, the trace elements, vitamins, selenium, and zinc supplements can be the same as for 1L bags.

• Junyelt (Composition per vial: Zinc 15.30 µmol; Copper 3.15 µmol; Manganese 0.091 µmol; Iodine 0.079 µmol; Selenium 0.253 µmol)

• Multivitamins 1 vial in combination (Composition per vial: Vit. B1 (thiamine) 2.5 mg, Vit. B2 (riboflavin) 3.6 mg, Vit. B6 (pyridoxine) 4.00 mg, Vit. B5 (pantothenic acid) 15.0 mg, Vit. C (ascorbic acid) 100 mg, Vit. B8 (biotin) 0.06 mg, Vit. B9 (folic acid) 0.4 mg, Vit. B12 (cyanocobalamin) 0.005 mg, Vit. PP (nicotinamide) 40 mg) and 1 vial multivitamin (Composition per vial: Vit. A (as retinol palmitate) 2300 IU, Vit. D (as ergocalciferol) 400 IU, Vit. E (alpha-tocopherol) 6.4 mg, Vit. K (phytomenadione) 200 µg)

Possible supplements for 1000 ml of Olimel N12E (for adult patients)

• Includes phosphate provided by the lipid emulsion.

• Pi inorganic phosphate; Po organic phosphate

• For all formats, the trace elements, vitamins, selenium, and zinc supplements can be the same as for 1L bags. The addition of vitamins is per liter of emulsion.

• (Composition per vial: Zinc 153 µmol; Copper 4.7 µmol; Manganese 1.0 µmol; Fluoride 50 µmol; Iodine 1.0 µmol; Selenium 0.9 µmol; Molybdenum 0.21 µmol; Chromium 0.19 µmol; Iron 18 µmol)

• Cernevit (Composition per vial: Vit. A (as retinol palmitate) 3500 IU, Vit. D3 (cholecalciferol) 220 IU, Vit. E (alpha-tocopherol) 11.2 IU, Vit. C (ascorbic acid) 125 mg, Vit. B1 (thiamine) 3.51 mg, Vit. B2 (riboflavin) 4.14 mg, Vit. B6 (pyridoxine) 4.53 mg, Vit. B12 (cyanocobalamin) 6 µg, Vit. B9 (folic acid) 414 µg, Vit. B5 (pantothenic acid) 17.25 mg, Vit. B8 (biotin) 69 µg, Vit. PP (nicotinamide) 46 mg)

To make an addition:

• It must be carried out under aseptic conditions.
• Prepare the injection point of the bag.
• Puncture the injection point and inject the additives using an injection needle or a reconstitution device.
• Mix the contents of the bag and the additives.

Validity period after reconstitution:

The chemical and physical stability of use has been demonstrated for 7 days (between 2 °C and 8 °C) followed by 48 hours at a temperature not exceeding 30 °C.

From a microbiological point of view, after reconstitution, the product should be used immediately. If it is not used immediately, the conditions and times of storage in use, after reconstitution and before use, are the responsibility of the user and normally will not exceed 24 hours at 2 °C to 8 °C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

Validity period after addition of supplements:

For certain mixtures, the chemical and physical stability of use has been demonstrated for 7 days (between 2 °C and 8 °C) followed by 48 hours at a temperature not exceeding 30 °C.

From a microbiological point of view, any mixture should be used immediately. If it is not used immediately, the conditions and times of storage in use, after mixing and before use, are the responsibility of the user and normally will not exceed 24 hours at 2 °C to 8 °C, unless the addition of supplements has been carried out under controlled and validated aseptic conditions.

Preparation for infusion

It should be carried out under aseptic conditions.

Hang the bag.

Remove the plastic protector from the administration outlet.

Firmly insert the tip of the infusion equipment into the administration outlet.

Table 1: Preparation steps for the administration of Olimel N12E

Administration

For single use only.

Administer the product only after the non-permanent seals between the three compartments have been broken and the contents of the three compartments have been mixed.

Make sure the final emulsion for infusion shows no phase separation.

After opening the bag, the contents should be used immediately. The opened bag should never be stored for later infusion. Do not reconnect a partially used bag.

Do not connect bags in series to avoid the risk of gas embolism due to the gas present in the first bag.

All unused medication, materials that have come into contact with it, and all necessary devices should be discarded.

Extravasation

The catheter area should be regularly inspected to identify signs of extravasation.

If extravasation occurs, administration should be stopped immediately, keeping the cannula or catheter in place for immediate patient treatment. If possible, an aspiration should be performed through the inserted cannula/catheter to reduce the amount of fluid present in the tissues before removing the cannula/catheter.

Specific measures should be taken depending on the stage or extent of any injury caused by the extravasated product (including the products mixed with Olimel N12E).

Treatment options may include pharmacological, non-pharmacological, and/or surgical intervention. In the case of significant extravasation, a plastic surgeon should be consulted within the first 72 hours.

The extravasation area should be inspected at least every 4 hours during the first 24 hours and then once a day.

Infusion should not be resumed in the same central vein.