FINOMEL

Package leaflet: Information for the user

Finomel infusion emulsion

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this 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 side 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 (used to build proteins), glucose (carbohydrates), lipids (fats), and salts (electrolytes).
Finomel is used to provide nutrition to adults through a vein when normal oral feeding is not suitable.

2. What you need to know before using Finomel

Do not use Finomel:

• if you are allergic to fish proteins, egg, soybean seeds, peanuts, or cereals and their derivatives (see also section "Warnings and precautions" below), or to any of the other ingredients of this medicine (listed 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 in which your body cannot metabolize amino acids;
• if you have severe kidney problems;
• if you have high blood sugar levels;
• if you have excessively high levels of electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in the blood;
• if you have difficulty infusing large volumes of fluid into your veins, such as acute pulmonary edema, hyperhydration, or decompensated heart conditions;
• if you have a severe and acute medical condition 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 receive this medicine based on factors such as age, weight, clinical condition, and test results.

Warnings and precautions

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

• severe kidney problems. You must inform your doctor if you are on dialysis or undergoing other blood purification treatments;
• severe liver problems;
• blood coagulation disorders;
• underactive adrenal glands (adrenal insufficiency). The adrenal glands are triangular-shaped and located above the kidneys;
• heart failure;
• lung disease;
• fluid accumulation in the body (hyperhydration);
• insufficient body fluids (dehydration);
• high blood sugar (diabetes mellitus) that is untreated;
• a heart attack or shock due to a sudden cardiac event;
• severe metabolic acidosis (blood is too acidic);
• a severe infection (sepsis).

If signs or symptoms of an allergic reaction develop, such as fever, chills, skin reactions, or difficulty breathing, the infusion will be stopped immediately. This medicine contains fish oil, soybean seed oil, egg phospholipid proteins, and glucose derived from cereals, which may cause hypersensitivity reactions. Cross-allergic reactions between soybean seed proteins and peanuts have been observed. Difficulty in breathing may also be a sign of formation of small particles blocking blood vessels in the lungs (pulmonary vascular precipitates). If you experience breathing difficulties, inform your doctor or nurse, who will decide on the appropriate action.

During the infusion, inform your doctor or nurse if you notice burning, stiffness, swelling, or abnormal skin color at the infusion site. Administration will be stopped immediately and restarted in another vein.

When inserting a tube (intravenous catheter) into a vein, there is a particular risk of infection or sepsis (bacteria or toxins in the blood). Your doctor will carefully examine you for any signs of infection. Using an "aseptic technique" ("germ-free") when placing and maintaining the catheter and preparing the nutritional formulation can reduce the risk of infection.

With similar products, a fat overload syndrome has been reported. Reduced or limited ability of the body to clear the fats contained in Finomel may lead to a "fat overload syndrome" (see section 4 - Possible side effects).

If you have severe malnutrition requiring intravenous feeding, parenteral nutrition should be initiated slowly and cautiously.

Additional monitoring tests

Before starting the infusion, water and electrolyte balance and metabolic disturbances should be corrected. To monitor the ongoing efficacy and safety of administration, your doctor may perform clinical and laboratory tests while you are receiving this medicine. Your doctor will monitor your condition and may adjust the dosage or administer additional medication as needed.

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 take any other medicines.

Finomel contains calcium. It must not be administered simultaneously or through the same tubing with the antibiotic ceftriaxone, as particles may form. If the same administration device is used to give these medicines one after the other, it must be thoroughly flushed.

The olive and soybean seed 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 (this usually occurs after a 5-6 hour interval without lipid infusion).

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before receiving this medicine. There are no data on the use of Finomel in pregnant or breastfeeding women. This medicine may be considered during pregnancy or breastfeeding if your doctor deems it necessary.

Driving and using machines

Not applicable, as this medicine is administered in a hospital setting.

3. How to use Finomel

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
This medicine is administered by intravenous infusion (drip) through a small tube directly into a vein.
Your doctor will determine the specific dose for you based on your body weight and how your body functions. Finomel will be administered to you by a healthcare professional.
Use in children
The safety and efficacy in children and adolescents under 18 years of age has not been established.
If you use more Finomel than you should
It is unlikely that you will receive an excessive amount of FINOMEL, as it is administered by a healthcare professional.

4. Possible side effects

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

• Hypersensitivity reactions (which may cause symptoms such as sweating, fever, drop in blood pressure, skin rashes, wheals (red and swollen areas), flushing, headache)
• Refeeding syndrome (a condition that develops when nutrition is reintroduced after prolonged fasting)
• High blood sugar levels (hyperglycaemia)
• Dizziness
• Headache
• Inflammation of the veins (thrombophlebitis)
• Pulmonary embolism
• Breathing difficulties
• Nausea
• Vomiting
• A slight increase in body temperature
• Elevated levels in the blood (plasma) of compounds originating from the liver
• Fat overload syndrome
• Leakage of the infusion into surrounding tissues (extravasation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finomel

Keep this medicine out of the sight and reach of children.
Store in the outer packaging. Do not freeze.
Do not use this medicine after the expiry date stated on the bag label and on the box after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible particles in the solution or if the bag is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Finomel contains

• The active substances are

g per 1000 ml
Alanine 10.52
Arginine 5.84
Glycine 5.23
Histidine 2.44
Isoleucine 3.05
Leucine 3.71
Lysine (as 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 monohydrate) 139.5
Soybean oil, purified 11.40
Olive oil, purified 9.50
Medium-chain triglycerides 9.50
Fish oil, rich in omega-3 fatty acids 7.60

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

Description of the appearance of Finomel and contents of the pack
The glucose and amino acid solutions are clear and colourless or slightly yellow, free from particles. The lipid emulsion is white and homogeneous.
After mixing the three compartments, the product appears as a white emulsion.
Pack sizes:
4 x 1085 mL
4 x 1435 mL
4 x 1820 mL

Marketing Authorisation Holder and Manufacturer
Baxter S.p.A.
Piazzale dell’Industria 20
00144 Rome
Italy

Manufacturer:
Baxter SA
Boulevard René Branquart 80
7860 Lessines
Belgium

This medicinal product is authorised in the EEA Member States under the following names:
Austria, Czech Republic, Germany, Greece, Ireland, Luxembourg,
Netherlands, Poland, Spain, United Kingdom: FINOMEL
Denmark, Finland, Iceland, Norway, Sweden: Finomel
France: Fosomel
Belgium, Luxembourg, Netherlands: Omegomel
<------------------------------------------------------------------------------------------------------------------------>

The following information is intended for healthcare professionals only:

A. QUALITATIVE AND QUANTITATIVE COMPOSITION
Finomel is available in a 3-compartment plastic bag. Each bag contains a sterile, pyrogen-free combination of 42% glucose solution, 10% amino acid solution with electrolytes, and 20% lipid emulsion.
The table below provides the composition of the reconstituted emulsion after mixing the contents of the 3 compartments.

B. DOSAGE AND ADMINISTRATION
Dosage
The dosage should be individualized according to the patient's energy expenditure, clinical condition,
body weight, and ability to metabolize the components of Finomel, as well as any additional energy or
proteins provided orally/enterally. Therefore, the bag size should be selected accordingly.
Average daily requirements in adults are:

• In patients with normal nutritional status or mild catabolic stress: 0.6–0.9 g of amino acids/kg body weight/day (0.10–0.15 g of nitrogen/kg body weight/day).
• In patients with moderate to severe metabolic stress, with or without malnutrition: 0.9–1.6 g of amino acids/kg body weight/day (0.15–0.25 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 according to the required dose, daily volumes to be administered, and duration of infusion. The recommended infusion duration is between 14 and 24 hours.

The dosage range of 13–31 mL/kg body weight/day corresponds to 0.7–1.6 g of
amino acids/kg body weight/day (0.11–0.26 g of nitrogen/kg body weight/day) and 14–33 kcal/kg body
weight/day of total energy (11–27 kcal/kg body weight/day of non-protein energy).
The maximum flow rate is 0.25 g/kg body weight/hour for glucose, 0.1 g/kg body weight/hour for amino
acids, and 0.15 g/kg body weight/hour for lipids.
The infusion rate must not exceed 2.0 mL/kg body weight/hour (equivalent to 0.1 g of amino acids, 0.25 g
of glucose, and 0.08 g of lipids/kg body weight/hour).
The maximum recommended daily dose is 35 mL/kg body weight/day, providing 1.8 g of amino
acids/kg body weight/day (equivalent to 0.29 g of nitrogen/kg body weight/day), 4.5 g of glucose/kg
body weight/day, 1.40 g of lipids/kg body weight/day, and 38 kcal/kg body weight/day of total energy
(equivalent to 30 kcal/kg body weight/day of non-protein energy).
Paediatric population
No studies have been conducted with Finomel 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 must be closely monitored.
Method of administration
For intravenous use, central vein infusion only.
For instructions on reconstitution of the medicinal product before administration, see section E.
Special precautions for disposal and handling.
For information on mixing with other infusions/blood before or during administration, see section C.
Incompatibilities.
C. INCOMPATIBILITIES
This medicinal product must not be mixed with any other medicinal products unless compatibility has been
documented.
Ceftriaxone must not be mixed or administered concomitantly with intravenous solutions containing
calcium, including Finomel.
Finomel must not be administered simultaneously with blood through the same infusion line.
D. OVERDOSAGE
In case of overdose, nausea, vomiting, chills, hyperglycaemia, and electrolyte disturbances may occur,
along with signs of hypervolaemia and acidosis. If this occurs, the infusion must be stopped immediately.
If hyperglycaemia develops, it should be managed according to the clinical situation, with appropriate
insulin administration and/or adjustment of the infusion rate. In addition, overdose may lead to fluid
overload, electrolyte imbalance, and hyperosmolarity.
If symptoms persist after discontinuation of the infusion, haemodialysis, haemofiltration, or
haemodiafiltration may be considered.
E. SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING
Opening:

• Remove the outer protective wrapper.
• Discard the oxygen absorber bag.
• Use only if the bag is undamaged, the non-permanent separation membranes are intact (i.e., no mixing of the contents of the three compartments has occurred), the amino acid solution and glucose solution are clear, colourless or slightly yellow, and practically free from visible particles, and the lipid emulsion is a homogeneous liquid with a milky appearance.

Mixing of compartments:

• Ensure the product is at room temperature when breaking the non-permanent separation membranes.
• Manually roll the bag from the top (end with loop) downwards. (Figure 1). The non-permanent separation membranes will disappear from the side adjacent to the openings. Continue rolling the bag until the separation membranes are opened along approximately half their length. (Figure 2)
• Mix the bag by inverting it at least three times. (Figure 3)
• After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.

After removing the protective cap from the medication access port, compatible additives may be added
through the same port. (See subsection "Additions")
Remove the protective cap from the infusion port and connect the infusion set.
Hang the bag on a suitable support and administer by standard infusion technique. (Figure 4)
After opening the bag, the contents must be used immediately. Never store an opened bag for subsequent
infusion.
Do not reconnect partially used bags. Do not connect bags in series to avoid the risk of gas embolism.

Additions
Before adding any substances, compatibility must be verified, as precipitation or destabilization of the
lipid emulsion could lead to vascular occlusion.
All additions must be performed under aseptic conditions.
The following additives may be mixed with Finomel:

• Multivitamin preparations
• Multiple trace element preparations
• Selenium
• Zinc
• Sodium salts
• Potassium salts
• Magnesium salts
• Calcium salts
• Phosphate salts

The compatibility table below indicates possible additions of a multiple trace element product such as Nutryelt, a multivitamin product such as Cernevit, and generic electrolytes and trace elements in defined quantities. The addition of clinically necessary electrolytes and trace elements should take into account the amounts already included in the initial bag formulation.

Compatibility may vary between products of different origins, and healthcare professionals are advised
to perform appropriate checks when mixing Finomel with other parenteral solutions.
Mix the contents of the bag thoroughly and visually inspect the mixture. There should be no signs of
emulsion separation. The mixture is a homogeneous white, milky emulsion.
When making additions, measure the final osmolarity of the mixture.

Package leaflet: Information for the user

Finomel Peripheral infusion emulsion

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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

2. What Finomel Peripheral is and what it is used for

Finomel contains amino acids (used to build proteins), glucose (carbohydrates), lipids (fats), and salts (electrolytes).
Finomel Peripheral is used to provide nutrition to adults through a tube inserted into a vein when normal oral feeding is not suitable.

4. What you need to know before using Finomel Peri

Do not use Finomel Peri:

• if you are allergic to fish proteins, eggs, soybeans, peanuts, or cereals and their derivatives (see also section "Warnings and precautions" below), or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of fats in your blood;
• if you have severe liver problems;
• if you have blood coagulation disorders;
• if you have a disorder preventing your body from properly processing amino acids;
• if you have severe kidney problems;
• if you have high blood sugar levels;
• if you have excessively high levels of electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in your blood;
• if you have problems receiving large amounts of fluids into your veins, such as acute pulmonary edema, hyperhydration, or decompensated heart conditions;
• if you have a serious and acute medical condition such as severe post-traumatic states, 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 receive this medicine based on factors such as age, weight, clinical condition, and test results.

Warnings and precautions

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

• Severe kidney problems. Inform your doctor if you are on dialysis or undergoing other blood purification treatments;
• Severe liver problems;
• Blood coagulation disorders;
• Adrenal gland insufficiency (adrenal glands not functioning properly). The adrenal glands are triangular-shaped and located above the kidneys;
• Heart failure;
• Lung disease;
• Fluid accumulation in the body (hyperhydration);
• Insufficient body fluids (dehydration);
• High blood sugar (diabetes mellitus) that is untreated;
• Heart attack or shock due to acute myocardial infarction;
• Severe metabolic acidosis (blood being too acidic);
• Severe infection (sepsis).

If signs or symptoms of an allergic reaction develop, such as fever, chills, skin reactions, or difficulty breathing, the infusion will be stopped immediately. This medicine contains fish oil, soybean seed oil, egg phosphatide proteins, and glucose derived from cereals, which may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.

Difficulty in breathing may also be a sign of small particles forming and blocking blood vessels in the lungs (pulmonary vascular precipitates). If you experience breathing difficulties, inform your doctor or nurse, who will decide on the appropriate action.

During infusion, inform your doctor or nurse if you notice burning, stiffness, swelling, or abnormal skin coloration at the infusion site. Administration will be stopped immediately and restarted in another vein.

When inserting a tube (intravenous catheter) into a vein, there is an increased risk of infection or sepsis (bacteria or toxins in the blood). Your doctor will carefully monitor you for signs of infection. Using an "aseptic technique" (germ-free) when placing and maintaining the catheter and preparing the nutritional formulation can reduce the risk of infection.

With similar products, fat overload syndrome has been reported. A reduced or limited ability of the body to clear the fats contained in Finomel Peri may lead to a "fat overload syndrome" (see section 4 - Possible side effects).

If you have severe malnutrition requiring parenteral nutrition, it is recommended to initiate parenteral feeding slowly and cautiously.

Additional monitoring tests

Before starting the infusion, water and electrolyte balance and metabolic disturbances should be corrected. To monitor ongoing efficacy and safety during administration, your doctor may perform clinical and laboratory tests while you are receiving this medicine. Your doctor will monitor your condition and may adjust the dosage or administer additional medication.

Children and adolescents

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

Other medicines and Finomel Peri

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

Finomel Peri contains calcium. It must not be administered simultaneously or through the same tubing with 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 seed oils in Finomel Peri 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 (this usually occurs after a 5-6 hour interval without lipid infusion).

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before receiving this medicine. There are no data on the use of Finomel Peri in pregnant or breastfeeding women. Use of this medicine during pregnancy or breastfeeding may be considered if your doctor deems it necessary.

Driving and using machines

Not applicable, as this medicine is administered in a hospital setting.

5. How to use Finomel Peri

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
This medicine is administered by intravenous infusion (drip) through a small tube directly into a vein.
Your doctor will determine the specific dose for you based on your body weight and how your body functions. Finomel Peri will be administered to you by a healthcare professional.
Use in children
The safety and efficacy in children and adolescents under 18 years of age has not been established.
If you use more Finomel Peri than you should
It is unlikely that you will receive an excessive amount of Finomel Peri, as it is administered by a healthcare professional.

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 a frequency not known:

• Hypersensitivity reactions (which may cause symptoms such as sweating, fever, drop in blood pressure, skin rashes, hives (red, swollen areas), flushing, headache)
• Re-feeding syndrome (a condition that develops when nutrition is reintroduced after prolonged fasting)
• High blood sugar levels (hyperglycaemia)
• Dizziness
• Headache
• Inflammation of the veins (thrombophlebitis)
• Pulmonary embolism
• Breathing difficulties
• Nausea
• Vomiting
• A slight increase in body temperature
• Elevated blood (plasma) levels of compounds originating from the liver
• Fat overload syndrome
• Leakage of infusion into surrounding tissues (extravasation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finomel Periferico

Keep this medicine out of the sight and reach of children.
Store in the outer packaging. Do not freeze.
Do not use this medicine after the expiry date stated on the bag label and on the box after "Exp". The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible particles in the solution or if the bag is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Finomel Periferico contains

• The active substances are

g per 1000
mL
Alanine 6.52
Arginine 3.62
Glycine 3.24
Histidine 1.51
Isoleucine 1.89
Leucine 2.30
Lysine (as hydrochloride) 2.28
Methionine 1.26
Phenylalanine 1.76
Proline 2.14
Serine 1.58
Threonine 1.32
Tryptophan 0.57
Tyrosine 0.13
Valine 1.83
Sodium acetate trihydrate 1.77
Potassium chloride 1.41
Calcium chloride dihydrate 0.23
Magnesium sulfate heptahydrate 0.78
Sodium glycerophosphate hydrate 1.87
Zinc sulfate heptahydrate 0.007
Glucose (as monohydrate) 77.8
Soybean oil, purified 8.46
Olive oil, purified 7.05
Medium-chain triglycerides 7.05
Fish oil, rich in omega-3 fatty acids 5.64

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

Description of the appearance of Finomel Periferico and package contents
The glucose and amino acid solutions are clear, colourless or slightly yellow, and free from particles. The lipid emulsion is white and homogeneous.
After mixing the three compartments, the product appears as a white emulsion.
Pack sizes:
4 x 1085 mL
4 x 1450 mL
4 x 2020 mL

Marketing Authorization Holder and Manufacturer
Baxter S.p.A.
Piazzale dell’Industria 20
00144 Rome
Italy

Manufacturer:
Baxter SA
Boulevard René Branquart 80
7860 Lessines
Belgium

This medicinal product is authorized in the EEA Member States under the following names:
Austria, Belgium, Czech Republic, Germany, Greece, FINOMEL PERI
Ireland, Italy, Luxembourg, Netherlands, Poland,
Spain, United Kingdom
Denmark, Finland, Iceland, Norway, Sweden Finomel Perifer
France Fosomel Peri
Periomegomel
Belgium, Luxembourg, Netherlands
<------------------------------------------------------------------------------------------------------------------------>

The following information is intended for healthcare professionals only:

A. QUALITATIVE AND QUANTITATIVE COMPOSITION
Finomel Peripheral is available in a 3-compartment plastic bag. Each bag contains a sterile, pyrogen-free combination of 13% glucose solution, 10% amino acid solution with electrolytes, and 20% lipid emulsion.
The table below provides the composition of the reconstituted emulsion after mixing the contents of the 3 compartments.

B. DOSAGE AND ADMINISTRATION
Dosage
The dosage should 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 to any additional
energy or protein provided orally/enterally. Therefore, the bag size should be selected accordingly.
Average daily requirements for adults are:

• In patients with normal nutritional status or mild catabolic stress: 0.6–0.9 g of amino acids/kg body weight/day (0.10–0.15 g of nitrogen/kg body weight/day).
• In patients with moderate to severe metabolic stress with or without malnutrition: 0.9–1.6 g of amino acids/kg body weight/day (0.15–0.25 g of nitrogen/kg body weight/day).
• In patients under 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 must be adjusted according to the required dose, the daily volume to be administered, and the duration of infusion.
The recommended infusion duration ranges between 14 and 24 hours.
The dosage range of 20–40 mL/kg body weight/day corresponds to 0.6–1.3 g of amino acids/kg body weight/day (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 is 0.25 g/kg body weight/hour for glucose, 0.1 g/kg body weight/hour for amino acids, and 0.15 g/kg body weight/hour for lipids.
The infusion rate must not exceed 3.0 mL/kg body weight/hour (equivalent to 0.09 g of amino acids, 0.21 g of glucose, and 0.09 g of lipids/kg body weight/hour).
The recommended maximum daily dose is 40 mL/kg body weight/day, providing 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 27 kcal/kg body weight/day of total energy (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 impairment, including cholestasis and/or elevated liver enzymes. Liver function parameters must be closely monitored.

Method of administration
For intravenous use, infusion into a peripheral or central vein.
For instructions on reconstitution of the medicinal product before administration, see section E. Special precautions for disposal and handling.
When infusing via peripheral veins, the osmolarity of the solution should be considered, as thrombophlebitis may occur. The catheter insertion site should be assessed daily for local signs of thrombophlebitis.
For information on mixing with other infusions/blood before or during administration, see section C. Incompatibilities.

C. INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products unless compatibility has been documented.
Ceftriaxone must not be mixed or administered concomitantly with intravenous solutions containing calcium, including Finomel Peri.
Finomel Peri must not be administered simultaneously with blood through the same infusion line.

D. OVERDOSE
In case of overdose, symptoms such as nausea, vomiting, chills, hyperglycaemia, and electrolyte disturbances may occur, along with signs of hypervolaemia and acidosis. If this occurs, the infusion must be stopped immediately.
If hyperglycaemia occurs, it should be managed according to the clinical situation, with appropriate insulin administration and/or adjustment of the infusion rate. In addition, overdose may lead to fluid overload, electrolyte imbalance, and hyperosmolarity.
If symptoms persist after discontinuation of the infusion, haemodialysis, haemofiltration, or haemodiafiltration may be considered.

E. SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING
Opening:

• Remove the outer protective envelope.
• Discard the oxygen absorber bag.
• Use only if the bag is undamaged, the non-permanent separation membranes are intact (i.e., no mixing of the contents of the three compartments has occurred), the amino acid solution and glucose solution are clear, colourless or slightly yellow, and essentially free from visible particles, and the lipid emulsion is a homogeneous liquid with a milky appearance.

Mixing of compartments:

• Ensure the product is at room temperature when breaking the non-permanent separation membranes.
• Manually roll the bag over itself, starting from the top (end with loop). (Figure 1) The non-permanent separation membranes will disappear from the side adjacent to the openings. Continue rolling the bag until the separation membranes are open along approximately half their length. (Figure 2)
• Mix the bag by inverting it at least three times. (Figure 3)
• After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.

After removing the protective cap from the medication access port, compatible additives may be introduced through the same port. (See sub-section "Additions")
Remove the protective cap from the infusion access port and connect the infusion set.
Hang the bag on an appropriate support and administer by standard infusion technique. (Figure 4)
After opening the bag, the contents should be used immediately. Never store an opened bag for subsequent infusion.
Do not reconnect partially used bags. Do not connect bags in series to avoid the risk of gas embolism.

Additions
Compatibility must be verified before any additions, as precipitation or destabilization of the lipid emulsion may lead to vascular occlusion.
All additions must be performed under aseptic conditions.
The following additives may be mixed with Finomel Peri:

• Multivitamin preparations
• Multi-oligoelement preparations
• Selenium
• Zinc
• Sodium salts
• Potassium salts
• Magnesium salts
• Calcium salts
• Phosphate salts

The compatibility table below indicates possible additions of a multi-oligoelement product such as Nutryelt, a multivitamin product such as Cernevit, and generic electrolytes and oligoelements in defined quantities. The addition of clinically necessary electrolytes and oligoelements should take into account the amounts already included in the initial bag formulation.

Vial volume: 10 mL of concentrated solution
Vial volume: 5 mL of lyophilisate
Compatibility may vary between products of different origins, and healthcare personnel are advised
to perform adequate checks when mixing Finomel Peripheral with other parenteral solutions.
Mix the contents of the bag thoroughly and visually inspect the mixture. There should be no signs of emulsion separation. The mixture is a homogeneous white milky emulsion.
When making additions, especially before administration via peripheral vein, measure the final osmolarity of the mixture.