Finomel

Leaflet accompanying the packaging: Information for the user

Finomel, infusion emulsion

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Finomel and what is it used for
• 2. Important information before using Finomel
• 3. How to use Finomel
• 4. Possible side effects
• 5. How to store Finomel
• 6. Contents of the pack and other information

1. What is Finomel and what is it used for

Finomel contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fats) and salts (electrolytes). Finomel is used for nutrition in adults when normal oral nutrition is not sufficient or appropriate.

2. Important information before using Finomel

When not to use Finomel:

• if you are allergic to fish, eggs, soy, peanut proteins or corn/corn products (see also "Warnings and precautions" below) or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of fat in your blood;
• if you have severe liver disease;
• if you have blood clotting disorders;
• if you have a disease that prevents your body from processing amino acids;
• if you have severe kidney disease;
• if you have too high blood sugar levels;
• if you have abnormally high levels of any of the electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in your blood;
• if you have problems when taking large volumes of fluid into your veins, such as acute pulmonary edema, overhydration and uncontrolled heart failure;
• if you have any acute and severe health disorder, such as severe traumatic disorders, uncontrolled diabetes, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis (bacteria in the blood), hypotonic dehydration and hyperosmolar coma.

In each case, your doctor will decide whether to administer the medicine based on factors such as age, body weight and clinical condition, including the results of any tests performed.

Warnings and precautions

Before starting treatment with Finomel, you should discuss with your doctor or nurse if you have:

• severe kidney disease. You should also inform your doctor if you are undergoing dialysis (artificial kidney) or other methods of blood purification;
• severe liver disease;
• blood clotting disorders;
• adrenal insufficiency (adrenal gland failure). The adrenal glands are triangular glands located on top of the kidneys;
• heart failure;
• pulmonary disease;
• fluid accumulation in the body (overhydration);
• insufficient water in the body (dehydration);
• uncontrolled high blood sugar levels (diabetes);
• heart attack or shock due to sudden heart failure;
• severe metabolic acidosis (too acidic blood);
• severe infection (sepsis).

If unusual signs or symptoms of an allergic reaction occur, such as fever, chills, skin rash or difficulty breathing, the infusion should be stopped immediately. The medicine contains fish oil, soy oil and egg yolk phospholipids and glucose derived from corn, which may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins. Difficulty breathing may also be a sign that small particles are blocking blood vessels in the lungs (pulmonary embolism). If you experience any difficulty breathing, you should tell your doctor or nurse. They will decide on the appropriate action. If pain, burning, stiffness, swelling or discoloration of the skin occurs at the infusion site or if the infused fluid leaks, you should inform your doctor or nurse. The administration of the medicine will be stopped immediately and then resumed in a different vein. There is a particular risk of infection or sepsis (presence of bacteria or their toxins in the blood) after inserting a tube (central venous catheter) into the patient's vein. Your doctor will closely monitor you to detect any signs of infection. Using "aseptic technique" (absence of microorganisms) when inserting and maintaining the catheter and when preparing the medicine for infusion can reduce the risk of infection. With the use of similar medicines, the occurrence of fat overload syndrome has been reported. Reduced or limited ability of the body to eliminate fats contained in Finomel may result in so-called "fat overload syndrome" (see section 4 - Possible side effects). If the patient is severely malnourished, so that they need to receive food intravenously, it is recommended to start parenteral nutrition slowly and cautiously. Additional monitoring testsBefore starting the infusion, any disturbances in the patient's water and electrolyte balance and metabolic disorders should be corrected. Your doctor may perform clinical and laboratory tests during the administration of this medicine to monitor its effectiveness and safety. Your doctor will monitor you and may change the dosage or administer additional medication.

Children and adolescents

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

Finomel and other medicines

You should tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Finomel contains calcium. It should not be administered together or through the same line as the antibiotic ceftriaxone, as particles may form. If these medicines are administered sequentially using the same device, it should be thoroughly flushed. The olive and soy oil present in Finomel contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as coumarin. However, if you are taking anticoagulant medicines, you should inform your doctor. The fats in the emulsion may interfere with the results of some laboratory tests if the blood sample for the test is taken before the fats are eliminated from the patient's bloodstream (they are eliminated from the blood after 5 to 6 hours after administration of the fats).

Pregnancy, breastfeeding and fertility

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 is no data on the use of Finomel during pregnancy and breastfeeding. The use of this medicine during pregnancy and breastfeeding may be considered if your doctor thinks it is necessary.

Driving and using machines

This is not relevant as this medicine is administered in a hospital.

3. How to use Finomel

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor. This medicine is given as an intravenous infusion (drip) through a small tube directly into a vein. Your doctor will decide on the dose individually for each patient, depending on body weight and the patient's condition. Finomel will be administered by medical staff.

Use in children

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

Use of a higher than recommended dose of Finomel

It is unlikely that you will receive too much of this medicine because Finomel is administered by medical staff.

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 (causing symptoms such as swelling, fever, low blood pressure, skin rashes, blisters (raised red areas), sudden skin redness, headache)
• re-feeding syndrome (a disease that occurs after receiving nutrition after prolonged starvation)
• high blood sugar levels (hyperglycemia)
• dizziness
• headache
• phlebitis (thrombophlebitis)
• pulmonary embolism
• breathing difficulties
• nausea
• vomiting
• mildly elevated body temperature
• high levels of liver-derived compounds in the blood (in serum)
• fat overload syndrome
• infusion leakage into surrounding tissues (extravasation)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finomel

The medicine should be stored out of the sight and reach of children. Store in protective bags. Do not freeze. Do not use this medicine after the expiry date stated on the bag label and on the carton. The expiry date refers to the last day of the month stated. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Finomel contains

• The active substances of Finomel are per 1000 mlAlanine 10.52, Arginine 5.84, Glycine 5.23, Histidine 2.44, Isoleucine 3.05, Leucine 3.71, Lysine (as lysine hydrochloride) 3.68, Methionine 2.03, Phenylalanine 2.84, Proline 3.45, Serine 2.54, Threonine 2.13, Tryptophan 0.91, Tyrosine 0.20, Valine 2.95, Sodium acetate trihydrate 2.85, Potassium chloride 2.28, Calcium chloride dihydrate 0.38, Magnesium sulfate heptahydrate 1.25, Sodium glycerophosphate hydrate 3.01, Zinc sulfate heptahydrate 0.012, Glucose (as glucose monohydrate) 139.5, Refined soybean oil 11.40, Refined olive oil 9.50, Medium-chain triglycerides 9.50

Omega-3 fatty acid-rich fish oil 7.60

• The other ingredients are: glacial acetic acid, hydrochloric acid, egg phospholipids, glycerol, sodium oleate, all-rac-α-tocopherol, sodium hydroxide, water for injections.

What Finomel looks like and contents of the pack

The glucose and amino acid solutions are clear and colorless to slightly yellow and do not contain solid particles. The fat emulsion is white and homogeneous. After mixing the contents of the 3 chambers, the medicine is a white emulsion. Pack sizes: 4 x 1085 ml, 4 x 1435 ml, 4 x 1820 ml

Marketing authorization holder and importer

Marketing authorization holder: Baxter Polska Sp. z o.o., Ul. Kruczkowskiego 8, 00-380 Warsaw. Importer: 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:

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

A. QUALITATIVE AND QUANTITATIVE COMPOSITION

Finomel is packaged in triple-chamber, plastic bags. Each bag contains a sterile, apyrogenic 42% glucose solution, a 10% amino acid solution with electrolytes, and a 20% fat emulsion. The composition of the final emulsion after mixing the contents of the three chambers is shown in the table below:

B. DOSAGE AND ADMINISTRATION

Dosage

Dosage should be individualized, depending on energy expenditure, the patient's clinical condition, body weight and the ability to metabolize the components of Finomel, as well as the energy and protein components additionally administered enterally. Therefore, the bag size should be chosen accordingly. Average daily requirements for adult patients are:

• for patients with normal nutritional status or in mild catabolic stress: 0.6 - 0.9 g amino acids/kg body weight/day (0.10 - 0.15 g nitrogen/kg body weight/day);
• for patients with moderate or high metabolic stress with or without malnutrition: 0.9 - 1.6 g amino acids/kg body weight/day (0.15 - 0.25 g nitrogen/kg body weight/day);
• for patients in special conditions (e.g. with burns or significant anabolism), nitrogen requirements may be even higher.

The maximum daily dose varies depending on the patient's clinical condition and may change from day to day. The infusion rate should be increased gradually during the first hour. The infusion rate must be adjusted taking into account the administered dose, daily volume and infusion duration. The recommended infusion duration is 14 to 24 hours. The dose range of 13 - 31 ml/kg body weight/day corresponds to 0.7 - 1.6 g amino acids/kg body weight/day (which corresponds to 0.11 - 0.26 g nitrogen/kg body weight/day) and 14 - 33 kcal/kg body weight/day of total energy value (11 - 27 kcal/kg body weight/day of non-protein energy value). The maximum infusion rate of glucose is 0.25 g/kg body weight/hour, amino acids 0.1 g/kg body weight/hour and fats 0.15 g/kg body weight/hour. The infusion rate should not exceed 2.0 ml/kg body weight/hour (which corresponds to 0.10 g amino acids, 0.25 g glucose and 0.08 g fats/kg body weight/hour). The recommended maximum daily dose is 35 ml/kg body weight/day and will provide 1.8 g amino acids/kg body weight/day (which corresponds to 0.29 g nitrogen/kg body weight/day), 4.5 g glucose/kg body weight/day, 1.40 g lipids/kg body weight/day and a total energy value of 38 kcal/kg body weight/day (which corresponds to 30 kcal/kg body weight/day of non-protein energy value). Children and adolescentsNo studies have been conducted with Finomel in children and adolescents. Patients with renal/hepatic impairmentCaution should be exercised when administering to patients with hepatic impairment, including cholestasis and/or elevated liver enzymes. Liver function parameters should be closely monitored.

Administration

Intravenous administration, central venous infusion. Instructions for reconstitution of the medicine before administration, see section E. Special precautions for disposal and preparation of the medicinal product for administration. Information on mixing with other infusion solutions/blood before or during administration, see section C. Incompatibilities.

C. INCOMPATIBILITIES

This medicine should not be mixed with other medicines with which its compatibility has not been established. This medicine should not be mixed or administered with ceftriaxone or other calcium-containing intravenous solutions. Finomel should not be administered with blood through the same infusion set.

D. OVERDose

In case of overdose, nausea, vomiting, chills, hyperglycemia and electrolyte disturbances as well as signs of hypervolemia or acidosis may occur. In such cases, the infusion must be stopped immediately. In case of hyperglycemia, treatment should be instituted as appropriate for the clinical situation, administering insulin and/or adjusting the infusion rate. Additionally, overdose may cause fluid overload, electrolyte disturbances and hyperosmolality. If symptoms persist after stopping the infusion, hemodialysis, hemofiltration or hemodiafiltration may be considered.

E. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION

Opening:

• Remove the protective bag.
• Discard the oxygen absorber sachet.
• Use only if the bag is undamaged and the seals are intact (i.e. the contents of the three chambers have not been mixed), the amino acid and glucose solutions are clear, colorless or slightly yellow, free of visible particles and the fat emulsion is homogeneous with a milky appearance.

Mixing the contents of the chambers:

• Before breaking the seals, ensure that the medicine is at room temperature.
• Starting from the top of the bag (at the handle), roll the bag with both hands (Figure 1). The seals will break from the port side. Continue rolling the bag until the seals are broken halfway through. (Figure 2)
• Mix by turning the bag at least 3 times. (Figure 3)
• After mixing, the medicine is a homogeneous emulsion with a milky appearance.

After removing the protective cap from the medication port, additional compatible components can be added through the medication port (see "Addition"). Remove the protective cap from the infusion port and connect the infusion set. Suspend the bag on an infusion stand and perform the infusion using standard technique. (Figure 4)After opening the bag, the contents should be used immediately and the opened bag should not be stored for the next infusion. Do not reconnect partially used bags. To avoid the possibility of air embolism, do not connect bags in series.