Prospect: information for the user

Finomel emulsion for perfusion

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• Ifyouexperienceadverse effects,consultyour doctor or nurse,even if the adverse effects are not listed in this prospect. See section 4.

1.What Finomel is and for what it is used

2.What you need to know before starting to use Finomel

3.How to use Finomel

4.Possible adverse effects

5.Storage of Finomel

6.Contents of the package and additional information

Finomelcontains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes).

Finomelis used to feed adults when normal oral feeding is insufficient or not possible.

No use Finomel:

• If you are allergic to fish proteins, egg proteins, soy proteins, peanut proteins, corn or corn products (see also the section “Advertencias y precauciones” below), or any of the components of this medication (see the list in section 6).
• If you have high levels of fats in your blood.
• If you have severe liver problems.
• If you have severe blood clotting 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 your blood.
• If you have an abnormally high level of any of the electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus) in your blood.
• If you have difficulty receiving large volumes of liquids into your 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, severe metabolic acidosis, severe sepsis (bacteria in the blood), hypotonic dehydration, and coma hyperosmolar.

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

Advertencias y precauciones

Consult your doctor or nurse before starting to use Finomel if you have:

-any severe kidney problems. You should also inform your doctor if you are receiving dialysis (artificial kidney) treatment or if you 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-shaped glands located at the top of the kidneys.

-heart failure

-lung disease

-fluid accumulation in the body (hyperhydration)

-insufficient water in the body (dehydration)

-excessive sugar in the blood (diabetes mellitus) without receiving treatment for it

-heart attack or shock due to sudden cardiac failure

-severe metabolic acidosis (blood too acidic)

-generalized infection (septicemia)

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

Difficulty breathingcould also be a sign thatsmall particles have formed in the lungsthat block the blood vessels (vascular precipitatesin the lungs).If you experienceanydifficulty breathing,inform your doctor or nurse.They will decide on the course of action.

During the infusion, if you observe pain, burning, stiffness, swelling, or a change in skin color 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 catheter (intravenous catheter) is placed in the vein. Your doctor will closely monitor you for signs of infection. The use of "aseptic techniques" (germ-free) when placing and maintaining the catheter and preparing the nutritional formula can reduce the risk of infection.

Cases of lipid 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 lipid overload syndrome (see section 4: Possible side effects).

If you are severely malnourished to the point where you need to receive intravenous nutrition, it is recommended to initiate parenteral nutrition carefully and slowly.

Additional laboratory tests

Before starting the infusion, any metabolic disorders and the balance of water and electrolytes in your body should be corrected. To check the effectiveness and safety of the administration, your doctor may perform laboratory and clinical tests while you are receiving this medication. 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 medications and Finomel

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

Finomel contains calcium. It should not be administered together or through the same route with the antibiotic ceftriaxone because they may form particles.If the samedevice is used to administerthese medications in succession, it should bethoroughly cleaned.

The olive and soy oils present in Finomel 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 eliminatedfrom your bloodstream(they are usually eliminated after a period of 5 to 6 hours without receiving the lipids).

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before taking this medication. There is no information on the use of Finomel in pregnant women or breastfeeding women. This medication may be considered for use during pregnancy and lactation if your doctor determines it is necessary.

Driving and operating machinery

No, as the medication is administered in the hospital.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

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

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

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 medication, as a healthcare professional will administer Finomel.

Like all medications, this medication may produce adverse effects, although not all people will experience them. The following adverse effects have been reported with an unknown frequency:

• allergic reactions (which may cause symptoms such as swelling, fever, low blood pressure, skin eruptions, red raised patches, redness, headache;
• re-feeding syndrome (a disease that develops when you receive nutrition after long periods of fasting);
• high blood sugar concentrations (hyperglycemia);
• dizziness;
• headache;
• inflammation of the veins (thrombophlebitis);
• pulmonary embolism;
• difficulty breathing;
• nausea;
• vomiting;
• mild increase in body temperature;
• high concentrations in the blood (plasma) of liver compounds;
• steatosis syndrome;
• loss of perfusion in surrounding tissue (extravasation).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medication out of the sight and reachof children.

Store in the overwrap. Do not freeze.

Do not usethis medicationafter the expiration date that appears on the label of the bag and the outer packaging after CAD.The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Finomel Peri

• The active principles are

• The 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 contents of the container

The amino acid and glucose solutions are transparent, colorless or slightly yellowish and free of particles. 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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Baxter SL

Camilo Pouet Street, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Responsible for manufacturing:

Baxter SA

René Branquart Boulevard 80

7860 Lessines

Belgium

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

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

Belgium, Luxembourg, NetherlandsPeriomegomel

Denmark, Finland, Iceland, Norway, SwedenFinomel Perifer

FranceFosomelperi

ItalyFinomel

Last review date of this leaflet: December 2023

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

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This information is intended solely for healthcare professionals

A. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

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

B. POSOLOGÍA Y FORMA DE ADMINISTRACIÓN

Posología

The dose must be individualized according to the patient's energy expenditure, clinical condition, body weight and ability to metabolize the components of Finomel Peri, as well as the energy or protein administered orally or enterally. Therefore, the appropriate bag size must be chosen.

The average daily needs in adults are::

• In patients with normal nutritional 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 severe 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 according to the patient's clinical condition and may change from day to day.

The infusion rate must be increased gradually during the first hour.

The infusion rate must be adjusted taking into account the dose administered, the daily intake of volume and the duration of the infusion.

The recommended infusion 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 infusion 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 infusion rate must 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 recommended maximum 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 insufficiency

Use with caution in patients with hepatic insufficiency, including cholestasis and/or elevated liver enzymes. Liver function parameters must be closely monitored.

Form of administration

Intravenous use, infusion in a peripheral or central vein.

To consult the reconstitution instructions of the medicinal product before administration, see section E Precautions for special disposal and other manipulations.

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

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

C. INCOMPATIBILIDADES

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

This medicinal product must not be mixed or administered with ceftriaxone through the same infusion route.

Finomel Peri must not be administered with blood through the same infusion route.

D. SOBREDOSIS

In the event of overdose, nausea, vomiting, chills, hyperglycemia and electrolyte imbalances, as well as signs of hypervolemia or acidosis, may occur. In these cases, the infusion must be stopped immediately.

If hyperglycemia occurs, treatment must be carried out according to the clinical situation, with the administration of appropriate insulin and/or adjustment of the infusion rate. In addition, an overdose could cause fluid overload, electrolyte imbalances and hyperosmolarity.

If symptoms persist after stopping the infusion, hemodialysis, hemofiltration or hemodiafiltration may be considered.

E. PRECAUCIONES ESPECIALES DE ELIMINACIÓN Y OTRAS MANIPULACIONES

To open:

• Remove the protective overbag.
• Dispose of the absorbent oxygen sachet.
• Use it only if the bag is not damaged, the non-permanent seals are intact (i.e., the contents of the three compartments have not been mixed), the amino acid and glucose solutions in their respective chambers are transparent, colorless or slightly yellowish and free of visible particles, and the lipid emulsion is a homogeneous liquid with a milky appearance.

To mix the chambers:

• Ensure that the product is at room temperature when the non-permanent seals are broken.
• Roll the bag manually onto itself, starting from the top of the bag (extremity of the hanger).(Illustration 1)The non-permanent seals will disappear from the side closest to the inlets. Continue rolling it until the seals open approximately halfway along its length.(Illustration 2)
• Mix the bag by inverting it at least 3 times.(Illustration 3)
• The appearance after reconstitution is a homogeneous white emulsion.

After removing the protective cap from the medication port, additives compatible with the product may be added through the medication port (see the subsection "Additives").

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

After opening the bag, the contents must be used immediately. The opened bag must never be stored for subsequent infusion.

Do not reconnect a partially used bag. Do not connect bags in series to avoid gas embolism.

Adiciones

Additives must not be made to the bag without first checking compatibility, as the formation of precipitates or destabilization of the lipid emulsion may cause vascular occlusion.

Additives must be carried out in aseptic conditions.

Finomel Peri may be mixed with the following additives:

• multivitamin preparations
• preparations of multiple oligoelements
• selenium
• zinc
• sodium chloride
• potassium chloride
• magnesium chloride
• calcium chloride
• phosphate (organic, as sodium glycerophosphate)
• or
• phosphate (mineral, as potassium phosphate)

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

Compatibility may vary between products from different sources and it is recommended that healthcare professionals carry out the necessary checks when mixingFinomel Periwith 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 additives, the final osmolarity of the mixture must be measured before administering it through a peripheral vein.