FINOMEL EMULSION FOR INFUSION

2. What you need to know before you start using Finomel

Do not use Finomel:

• If you are allergic to fish proteins, egg, soy, and peanut, or to corn/corn products (see also the "Warnings and precautions" section below) or to any of the components of this medicine (see the list in section 6).
• If you have high levels of fat in the blood.
• If you have severe liver problems.
• If you have blood coagulation problems.
• If you have a disorder that prevents your body from processing amino acids.
• If you have severe kidney problems.
• If you have too much sugar in the blood.
• If you have an abnormally high amount of any of the electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus) in the blood.
• If you have problems receiving large volumes of liquids into the veins, such as acute pulmonary edema, hyperhydration, and decompensated heart problems.
• If you have any acute and severe health problems, such as severe post-traumatic conditions, uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis (bacteria in the blood), hypotonic dehydration, and hyperosmolar coma.

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 starting to use Finomel 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 glands located on top of the kidneys.
• heart failure
• lung disease
• fluid accumulation in the body (hyperhydration)
• insufficient amount of water in the body (dehydration)
• excess sugar in the blood (diabetes mellitus) without receiving treatment for it
• heart attack or shock due to sudden heart failure
• severe metabolic acidosis (blood too acidic)
• generalized infection (septicemia)

The infusion should be stopped immediately if any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, skin rash, or difficulty breathing. This medicine contains fish oil, soy oil, egg phosphatides, and glucose derived from corn, which may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soybean and peanut proteins.

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.

During the infusion, if you observe pain, burning, stiffness, swelling, or color change of the skin at the infusion site, or any leakage during the infusion, inform your doctor or nurse. The administration will be stopped immediately and restarted in another vein.

There is a risk of infection or sepsis (presence of bacteria or their toxins in the blood), especially when a tube (intravenous catheter) is placed in the vein. Your doctor will closely monitor you for signs of infection. The use of "aseptic techniques" (without germs) when placing and maintaining the catheter and preparing the nutritional formula can reduce the risk of infection.

Cases of fat overload syndrome have been described with similar products. A reduction or limitation of the body's ability to eliminate the fats contained in Finomel may cause a fat overload syndrome (see section 4: Possible side effects).

If you are severely malnourished and need to receive nutrition intravenously, it is recommended to start parenteral nutrition carefully and slowly.

Additional laboratory tests

Before starting the infusion, any metabolic disorders and water and electrolyte balance in your body should be corrected. To check the efficacy and safety of the administration, your doctor may perform laboratory and clinical tests while you are being given this medicine. Your doctor will monitor your condition and may change the dose or add another medication.

Children and adolescents

There is no experience with the use of Finomel in children and adolescents.

Other medicines and Finomel

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

Finomel contains calcium. It should not be administered together or through the same route with the antibiotic ceftriaxone, as particles may form. If the same device is used to administer these medicines successively, it should be rinsed well.

The olive and soy oils present in Finomel contain vitamin K. This usually does not affect blood-thinning medicines (anticoagulants), such as coumarin. However, if you take anticoagulants, you should tell your doctor.

The lipids 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 (they are generally eliminated after a period of 5 to 6 hours without receiving lipids).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. There are no data on the use of Finomel in pregnant or breastfeeding women. The use of this medicine during pregnancy and breastfeeding may be considered if your doctor determines that it is necessary.

Driving and using machines

This is not applicable, as the medicine is administered in the hospital.

3. How to use Finomel

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

This medicine is administered by intravenous infusion (drip) through a small tube, directly into a vein.

Your doctor will decide the dose that will be administered to you individually, depending on your body weight and functional status. A healthcare professional will administer Finomel to you.

Use in children

The safety and efficacy in children and adolescents under 18 years of age have not been established.

If you use more Finomel than you should

It is unlikely that you will receive too much medicine, as a healthcare professional will administer Finomel to you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with an unknown frequency:

• hypersensitivity reactions (which can give you symptoms such as swelling, fever, drop in blood pressure, skin rash, hives (red elevated spots), redness, headache;
• re-feeding syndrome (a disease that develops when you receive nutrition after long periods of fasting);
• high blood sugar levels (hyperglycemia);
• dizziness;
• headache;
• inflammation of the veins (thrombophlebitis);
• pulmonary embolism;
• breathing difficulties;
• nausea;
• vomiting;
• mild increase in body temperature;
• high levels of liver compounds in the blood (plasma);
• fat overload syndrome;
• loss of perfusion in the surrounding tissue (extravasation).

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 them 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 Finomel

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

Store in the overbag. Do not freeze.

Do not use this medicine after the expiry date which is stated on the label of the bag and the outer packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible particles in the solution or if the bag is damaged.

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 Content and Additional Information

Finomel Peri Composition

• The active principles are

• Other components are: glacial acetic acid, hydrochloric acid, egg phospholipids, glycerol, sodium oleate, all-rac-α-tocopherol, sodium hydroxide, water for injectable preparations.

Appearance of Finomel Peri and Container Content

The amino acid and glucose solutions are transparent, colorless or slightly yellowish and particle-free. The lipid emulsion is homogeneous and white in color.

After mixing the 3 chambers, the product has the appearance of a white emulsion.

Container sizes

4 bags of 1085 ml

4 bags of 1450 ml

4 bags of 2020 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Baxter SL

Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer:

Baxter SA

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:

Austria, Czech Republic, Germany, Greece, Ireland, Finomel Peri Poland, Spain, United Kingdom

Belgium, Luxembourg, Netherlands Periomegomel

Denmark, Finland, Iceland, Norway, Sweden Finomel Perifer

France Fosomelperi

Italy Finomel

Date of the last revision of this leaflet: December 2023

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

Finomel Peri is presented in a plastic bag with 3 compartments. Each bag contains a sterile and apyrogenic combination of 13% glucose solution, 10% amino acid solution with electrolytes, and 20% lipid emulsion.

After mixing the contents of the 3 compartments, the composition of the reconstituted emulsion is indicated in the following table:

• DOSAGE AND ADMINISTRATION

Dosage

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

The average daily needs in adults are:

• In patients with normal feeding status or mild catabolic stress: 0.6 to 0.9 g of amino acids/kg body weight/day (0.10 to 0.15 g of nitrogen/kg body weight/day).
• In patients with moderate to high metabolic stress, with or without malnutrition: 0.9 to 1.6 g of amino acids/kg body weight/day (0.15 to 0.25 g of nitrogen/kg body weight/day).
• In patients with special conditions (e.g., burns or marked anabolism), nitrogen needs may be even higher.

The maximum daily dose varies depending on the patient's clinical status and may change from day to day.

The administration rate should be gradually increased during the first hour.

The administration rate should be adjusted taking into account the dose being administered, daily volume intake, and the duration of perfusion.

The recommended perfusion time is 14 to 24 hours.

The regimen of 20 ml to 40 ml/kg body weight/day corresponds to 0.6-1.3 g of amino acids/kg body weight/day (corresponding to 0.10-0.21 g of nitrogen/kg body weight/day) and 14-27 kcal/kg body weight/day of total energy (11-22 kcal/kg body weight/day of non-protein energy).

The maximum perfusion rate for glucose is 0.25 g/kg body weight/h, for amino acids 0.1 g/kg body weight/h, and for lipids 0.15 g/kg body weight/h.

The perfusion rate should not exceed 3.0 ml/kg body weight/h (corresponding to 0.09 g of amino acids, 0.21 g of glucose, and 0.09 g of lipids/kg body weight/h).

The maximum recommended daily dose is 40 ml/kg body weight/day, which will provide 1.3 g of amino acids/kg body weight/day (corresponding to 0.21 g of nitrogen/kg body weight/day), 2.8 g of glucose/kg body weight/day, 1.2 g of lipids/kg body weight/day, and a total energy of 27 kcal/kg body weight/day (corresponding to 22 kcal/kg body weight/day of non-protein energy).

Pediatric population

No studies have been conducted with Finomel Peri in the pediatric population.

Patients with renal/hepatic impairment

Use with caution in patients with hepatic impairment, including cholestasis and/or elevated liver enzymes. Liver function parameters should be carefully monitored.

Administration

Intravenous use, perfusion in a peripheral or central vein.

To consult the instructions for reconstitution of the medicinal product before administration, see section E Special precautions for disposal and other handling.

If peripheral veins are used for perfusions, the osmolarity of the solutions should be taken into account, as thrombophlebitis may occur. The insertion site of the catheter should be evaluated daily to detect localized signs of thrombophlebitis.

To obtain information on mixing with other perfusions or blood before or during administration, see section C Incompatibilities.

• INCOMPATIBILITIES

This medicinal product should not be mixed with other medicinal products for which compatibility has not been documented.

Ceftriaxone should not be mixed or administered with intravenous solutions containing calcium, including Finomel Peri.

Finomel Peri should not be administered with blood through the same infusion line.

• OVERDOSE

In case of overdose, nausea, vomiting, chills, hyperglycemia, and electrolyte disturbances, as well as signs of hypervolemia or acidosis, may occur. In these cases, perfusion should be stopped immediately.

If hyperglycemia occurs, it should be treated according to the clinical situation, by administering adequate insulin and/or adjusting the perfusion rate. Similarly, an overdose could cause fluid overload, electrolyte imbalances, and hyperosmolarity.

If symptoms persist after discontinuing perfusion, hemodialysis, hemofiltration, or hemodiafiltration may be considered.

• SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

To open:

• Remove the protective overbag.
• Discard the sachet with the oxygen absorber.
• 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 in their respective chambers are transparent, colorless or slightly yellowish and free of visible particles, and if the lipid emulsion is a homogeneous, milky liquid.

To mix the chambers:

• 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). (Illustration 1)The non-permanent seals will disappear from the side closest to the entrances. Continue rolling until the seals are open about halfway along their length. (Illustration 2)
• Mix the bag by inverting it at least 3 times. (Illustration 3)
• The appearance after reconstitution is a homogeneous, milky emulsion.

After removing the protective cap from the medication port, compatible additives can be added through the medication port (see the subsection "Additions").

Remove the protective cap from the infusion port and connect the infusion equipment. Hang the bag on an infusion stand and perform the infusion using the usual technique. (Illustration 4)

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 air embolism.

Additions

No additions should be made to the bag without first checking compatibility, as the formation of precipitates or destabilization of the lipid emulsion could cause vascular occlusion.

Additions should be carried out under aseptic conditions.

Finomel Peri can be mixed with the following additives:

• multivitamin preparations
• multiple trace element preparations
• selenium
• zinc
• sodium salt
• potassium salt
• magnesium salt
• calcium salt
• phosphate salt

The following indicative compatibility table shows possible additions of products with multiple trace elements, such as Nutryelt, and multivitamin products, such as Cernevit, as well as generic electrolytes and trace elements in defined quantities. The addition of clinically necessary electrolytes and trace elements should take into account the quantities already included in the initial formulation of the bag.

Compatibility may vary between products from different sources, and healthcare professionals are advised to carry out the necessary checks when mixing Finomel Peri with other parenteral solutions.

Mix the contents of the bag well and visually inspect the mixture. There should be no signs of phase separation of the emulsion. The mixture is a homogeneous, white emulsion.

When making additions, the final osmolarity of the mixture should be measured before administration through a peripheral vein.