Finomel emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finomel infusion emulsion

Read this entire leaflet carefully before you start using this medicine, as 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.

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

  • If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Finomel is and what it is used for

Finomel contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fats), and salts (electrolytes).

Finomel is used to provide nutrition to adults when normal oral feeding is insufficient or not possible.

2. What you need to know before using Finomel

Do not use Finomel:

• If you are allergic to fish, egg, soybean, or peanut proteins, corn/corn products (see also the section “Warnings and precautions” below), or to any of the components of this medicine (see the list in section 6).
• If you have high levels of fats in the blood.
• If you have severe liver problems.
• If you have blood coagulation disorders.
• 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 abnormally high levels of any electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in the blood.
• If you have problems receiving large volumes of intravenous fluids, such as acute pulmonary edema, hyperhydration, or decompensated heart conditions.
• If you have any acute and severe health conditions, such as severe post-traumatic conditions, uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis (bacteria in the blood), hypotonic dehydration, or 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, together with the results of all tests performed.

Warnings and precautions

Talk to your doctor or nurse before using Finomel if you have:

• any severe kidney problems. You should also inform your doctor if you are undergoing dialysis (artificial kidney) or any other blood-cleansing treatment.
• any severe liver problems
• any blood coagulation disorders
• abnormal adrenal gland function (adrenal insufficiency). The adrenal glands are triangular-shaped glands located on top of the kidneys.
• heart failure
• lung disease
• fluid accumulation in the body (hyperhydration)
• insufficient body water (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)
• systemic infection (septicemia)

Infusion must 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, soybean oil, egg phospholipids, and glucose derived from corn, which may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut seed proteins have been observed.

Difficulty in breathing may also indicate the formation of small particles in the lungs that block blood vessels (pulmonary vascular precipitates). If you experience any breathing difficulty, inform your doctor or nurse. They will decide on the appropriate action.

During infusion, if you notice pain, burning, stiffness, swelling, or skin discoloration at the infusion site, or any leakage during infusion, notify your doctor or nurse. 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" (germ-free) when placing and maintaining the catheter and when preparing the nutritional formula can reduce the risk of infection.

Cases of fat overload syndrome have been reported with similar products. A reduced or limited capacity of the body to eliminate the fats contained in Finomel may lead to fat overload syndrome (see section 4: Possible side effects).

If you are severely malnourished and require intravenous feeding, parenteral nutrition should be initiated carefully and slowly.

Additional laboratory tests

Before starting the infusion, metabolic disorders and your body's water and electrolyte balance should be corrected. To monitor the effectiveness and safety of treatment, your doctor may perform laboratory and clinical tests while you are receiving this medicine. Your doctor will monitor your condition and may adjust the dose or add other medications.

Children and adolescents

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

Other medicines and Finomel

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Finomel contains calcium. It must not be administered simultaneously or through the same route as the antibiotic ceftriaxone, as particles may form. If the same device is used to administer these medicines consecutively, it must be thoroughly flushed.

The olive and soybean oils in Finomel contain vitamin K. This usually does not affect blood-thinning medicines (anticoagulants) such as coumarin. However, if you are taking anticoagulants, you must 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 cleared from your bloodstream (they are generally cleared within 5 to 6 hours after stopping lipid infusion).

Pregnancy and breastfeeding

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

Driving and using machines

Not applicable, as the medicine is administered in hospital.

3. How to use Finomel

Follow exactly the instructions for administration of this medicine given by your doctor. If in 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 to be administered 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 Finomel will be administered by a healthcare professional.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects have been reported with unknown frequency:

• hypersensitivity reactions (which may cause symptoms such as swelling, fever, drop in blood pressure, skin rashes, hives (red raised spots), flushing, headache);
• refeeding syndrome (a condition that develops when nutrition is reintroduced after long periods of fasting);
• elevated blood sugar levels (hyperglycemia);
• dizziness;
• headache;
• inflammation of the veins (thrombophlebitis);
• pulmonary embolism;
• breathing difficulties;
• nausea;
• vomiting;
• slight increase in body temperature;
• high blood (plasma) concentrations of liver compounds;
• fat overload syndrome;
• loss of perfusion in surrounding tissue (extravasation).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 outer pouch. Do not freeze.

Do not use this medicine after the expiry date stated on the bag and the outer packaging after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Finomel Peri

• The active substances are

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

Appearance of Finomel Peri and contents of the pack

Amino acid and glucose solutions are clear, colourless or slightly yellowish, and free from particles. The lipid emulsion is homogeneous and white in colour.

After mixing the three chambers, the product appears as a white emulsion.

Pack sizes

4 bags of 1085 ml
4 bags of 1450 ml
4 bags of 2020 ml

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Austria, Czech Republic, Germany, Greece, Ireland, Poland, Spain, United Kingdom: Finomel Peri
Belgium, Luxembourg, Netherlands: Periomegomel
Denmark, Finland, Iceland, Norway, Sweden: Finomel Perifer
France: Fosomelperi
Italy: Finomel

Date of latest review of this leaflet: December 2023

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

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This information is intended for healthcare professionals only

A. QUALITATIVE AND QUANTITATIVE COMPOSITION

Finomel Peri is supplied in a plastic bag with three compartments. Each bag contains a sterile, non-pyrogenic combination of 13% glucose solution, 10% amino acid solution with electrolytes, and 20% lipid emulsion.

After mixing the contents of the three compartments, the composition of the reconstituted emulsion is shown in the following table:

• DOSAGE AND ADMINISTRATION

Dosage

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

Average daily requirements 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 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 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 gradually increased during the first hour.

The infusion rate should be adjusted based on the dose administered, daily volume intake, and duration of 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 (equivalent 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 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 recommended maximum daily dose is 40 ml/kg body weight/day, which will provide 1.3 g of amino acids/kg body weight/day (equivalent 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).

Paediatric population

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

Patients with renal/hepatic impairment

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

Method of administration

For intravenous use, infusion into a peripheral or central vein.

For instructions on reconstitution of the medicinal product prior to administration, see section E Special precautions for disposal and other handling.

When peripheral veins are used for infusions, the osmolarity of the solutions should be considered, as thrombophlebitis may occur. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.

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

• INCOMPATIBILITIES

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

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

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

• OVERDOSE

In case of overdose, nausea, vomiting, chills, hyperglycaemia, and electrolyte disturbances, as well as signs of hypervolaemia or acidosis, may occur. In such cases, the infusion must be stopped immediately.

If hyperglycaemia occurs, it should be managed according to the clinical situation, using appropriate insulin administration and/or adjustment of the infusion rate. In addition, an overdose could lead to fluid overload, electrolyte imbalances, and hyperosmolarity.

If symptoms persist after stopping the infusion, haemodialysis, haemofiltration, or haemodiafiltration may be considered.

• SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

To open:

• Remove the protective overpouch.
• Discard the sachet containing the oxygen absorber.
• Use only if the bag is undamaged, the non-permanent seals are intact (i.e., the contents of the three compartments have not mixed), the amino acid solution and glucose solution in their respective chambers are clear, colourless or slightly yellowish, and free of visible particles, and the lipid emulsion is a homogeneous milky-appearing liquid.

To mix the compartments:

• Ensure the product is at room temperature when breaking the non-permanent seals.
• Manually roll the bag onto itself, starting from the top of the bag (hanger end). (Illustration 1) The non-permanent seals will disappear from the side near the ports. Continue rolling until the seals open approximately halfway along their length. (Illustration 2)
• Mix the bag by inverting it at least three times. (Illustration 3)
• After reconstitution, the appearance is a homogeneous milky emulsion.

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

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

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

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

Additions

Additions to the bag must not be made without first checking compatibility, as precipitation or destabilization of the lipid emulsion could lead to vascular occlusion.

Additions must be performed under aseptic conditions.

Finomel Peri may be mixed with the following additives:

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

The following indicative compatibility table shows possible additions of multiple trace elements products such as Nutryelt, multivitamin products such as Cernevit, and generic electrolytes and trace elements in defined amounts. The addition of clinically required electrolytes and trace elements should take into account the amounts 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 appropriate checks when mixing Finomel Peri with other parenteral solutions.

Mix the contents of the bag thoroughly and inspect the mixture visually. There should be no signs of phase separation of the emulsion. The mixture is a homogeneous emulsion with a milky white color.

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