What it is and what it is used for

for

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

• Dizziness Fat overload syndrome has been reported with similar products. The reduced or limited ability of

• Headache

FINOMEL contains amino acids (components used to build proteins), glucose (carbohydrates), lipids

the body to remove the fats contained in FINOMEL may result in a "fat overload syndrome" (see

• Inflammation of the veins (Thrombophlebitis)

Pack sizes:

(fat) and salts (electrolytes).

section 4 – Possible Side Effects).

• Pulmonary embolism

4x1085ml

• Difficulty in breathing

4x1435ml

If you are severely malnourished such that you need to receive feedings by vein, it is recommended

• Nausea

4x1820ml

that parenteral nutrition is started slowly and carefully.

• Vomitting

FINOMEL is used to provide nutrition to adults when normal feeding by mouth is insufficient or not suitable.

• A slightly raised body temperature

Marketing Authorisation Holder and Manufacturer

Additional monitoring tests

• High blood (plasma) levels of coumpounds from the liver

United Kingdom:

The balance of water and electrolytes in your body and metabolic disorders should be corrected before

• Fat overload syndrome

Baxter Healthcare Ltd

Do not use FINOMEL:

starting the infusion. To check the effectiveness and ongoing safety of the administration, your doctor

• Leakage of the infusion to the surrounding tissue (extravasation)

Caxton Way, Thetford,

• If you are allergic to fish, egg, soya-bean, peanut proteins, or corn/corn products (see also section

may perform clinical and laboratory tests while you are receiving this medicine. Your doctor will

"Warnings and precautions" below), or any of the other ingredients of this medicine (listed in section 6).

monitor your condition and may change the dosage or give you additional medication.

What you need to know before you take it

e FINOMEL

• If you have high level of fats in your blood

Norfolk, IP24 3SE Reporting of side effects

United Kingdom

If you get any side effects talk to your doctor or nurse. This includes any possible side effects not

• If have severe problems with your liver

Children and adolescents

listed in this leaflet. You can also report side effects directly, via the methods listed below. By

Ireland:

• If you have blood coagulation problems

At the moment, there is no experience of the use of FINOMEL in children and adolescents.

reporting side effects you can help provide more information on the safety of this medicine.

Baxter Holding B.V.

• If you have a disorder whereby amino acids cannot be processed by the body

Kobaltweg 49,

• If you have severe problems with your kidneys

Other medicines and FINOMEL

United Kingdom : via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for

3542CE Utrecht,

• If you have too much sugar in your blood

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

MHRA Yellow Card in the Google Play or Apple App Store

Netherlands

• If you have an abnormally high amount of any of the electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in your blood

FINOMEL contains calcium. It should not be given together or through the same tube with the

Ireland : HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971;

Manufacturer:

• If you have problems receiving large volumes of liquids in your veins such as acute pulmonary

antibiotic ceftriaxone because particles may form. If the same device is used to give you successively

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected].

Baxter SA

oedema, hyperhydration and decompensated heart problems

these medicines, it should be thoroughly rinsed.

Boulevard René Branquart 80

• If you have any acute and severe health problem such as severe post-traumatic conditions, uncontrolled

7860 Lessines

diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis

The olive and soya-bean oils present in FINOMEL contain vitamin K. This does not normally affect

(bacteria in the blood), hypotonic dehydration and hyperosmolar coma

blood thinning medicines (anticoagulants) like coumarin. However, if you take anticoagulant medicines you should tell your doctor.

In all cases, your doctor will base his/her decision on whether you should receive this medicine on factors such as age, weight and clinical condition, together with the results of any tests performed.

How to take it

FINOMEL

and restarted in another vein.

4. Possible side effects

Possible side effects

• The other ingredients are: Glacial acetic acid, hydrochloric acid, egg phospholipids, glycerol, sodium Like all medicines, this medicine can cause side effects, although not everybody gets them. The

oleate, all-rac-α-Tocopherol, sodium hydroxide, water for injections.

following side effects have been reported at an unknown frequency:

5. How to store FINOMEL

There is a particular risk of infection or sepsis (bacteria or their toxins in the blood) when a tube

• Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin

What FINOMEL looks like and contents of the pack

How to store it

FINOMEL

Belgium This medicinal product is authorised in the Member States of the EEA under the following names:

Keep this medicine out of the sight and reach of children. Store in the overpouch. Do not freeze.

The lipids contained in this emulsion may interfere with the results of certain laboratory tests if the

Austria, Czech Republic, Germany, Greece, Ireland, Poland, Spain, United Kingdom Belgium, Luxembourg, Netherlands Denmark, Finland, Iceland, Italy,Norway, Sweden France

FINOMEL

blood sample is taken before the lipids have been eliminated (these are generally eliminated after a

Do not use this medicine after the expiry date which is stated on the label on the bag and carton after

period of 5 to 6 hours without receiving lipids).

EXP. The expiry date refers to the last day of that month.

• A severe kidney problem. You also must inform your doctor if you are on dialysis (artificial kidney)

Pregnancy and breast-feeding

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

or if you have another form of blood cleaning treatment

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

• A severe liver problem

your doctor for advice before you're given this medicine. There is no data from the use of FINOMEL

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

This leaflet was last revised in March 2019.

• A blood coagulation problem

in pregnancy or breast-feeding women. The use of this medicine during pregnancy and breast-feeding

throw away medicines you no longer use. These measures will help protect the environment.

For information about FINOMEL or to request this leaflet in formats such as audio or large print please

• Adrenal glands that are not working properly (adrenal insufficiency). The adrenal glands are

may be considered if necessary as advised by your doctor.

Warnings and precautions Talk to your doctor or nurse before using FINOMEL if you have:

contact the Marketing Authorisation Holder: Tel: +44 1635 206345.

The following information is intended for healthcare professionals only:

A. QUALITATIVE AND QUANTITATIVE COMPOSITION FINOMEL is presented in a 3-compartment plastic bag. Each bag contains a sterile non-pyrogenic combination of a 42% glucose solution, a 10% amino acid solution with electrolytes, and a 20% lipid emulsion. Composition of the reconstituted emulsion after mixing the content of the 3 compartments is provided in the table below: Active Substance

1085 mL

1435 mL

1820 mL

Fish oil, rich in omega-3-acids Olive oil, refined Soya-bean oil, refined Medium-chain triglycerides Alanine Arginine Glycine Histidine Isoleucine Leucine Lysine (as Lysine hydrochloride) Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium acetate trihydrate Potassium chloride Calcium chloride dihydrate Magnesium sulfate heptahydrate Sodium glycerophosphate, hydrated Zinc sulfate heptahydrate Glucose anhydrous (as Glucose monohydrate)

8.24 g 10.30 g 12.36 g 10.30 g 11.41 g 6.34 g 5.68 g 2.64 g 3.31 g 4.02 g 3.20 g (3.99 g) 2.20 g 3.09 g 3.75 g 2.76 g 2.31 g 0.99 g 0.22 g 3.20 g 3.10 g 2.47 g 0.41 g 1.36 g 3.26 g 0.013 g 137.8 g (151.5 g)

10.92 g 13.65 g 16.38 g 13.65 g 15.09 g 8.38 g 7.51 g 3.50 g 4.37 g 5.32 g 4.23 g (5.29 g) 2.92 g 4.08 g 4.96 g 3.65 g 3.06 g 1.31 g 0.29 g 4.23 g 4.10 g 3.27 g 0.54 g 1.80 g 4.32 g 0.017 g 181.9 g (200.0 g)

13.84 g 17.30 g 20.76 g 17.30 g 19.13 g 10.63 g 9.52 g 4.44 g 5.54 g 6.75 g 5.36 g (6.70 g) 3.70 g 5.17 g 6.28 g 4.62 g 3.88 g 1.66 g 0.37 g 5.36 g 5.19 g 4.14 g 0.68 g 2.28 g 5.47 g 0.021 g 231.0 g (254.1 g)

B. POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be individualized depending on energy expenditure, the patient's clinical status, body weight, and ability to metabolize constituents of FINOMEL, as well as additional energy or proteins given orally/enterally. Therefore, the bag size should be chosen accordingly. The average daily requirements for adults are:

• In patients with normal nutritional state or in conditions with mild catabolic stress: 0.6-0.9 g amino acids/kg bw/day (0.10-0.15 g nitrogen/kg bw/day).

The following information is intended for healthcare professionals only:

• In patients with moderate to high metabolic stress with or without malnutrition: 0.9-1.6 g amino acids/kg bw/day (0.15-0.25 g nitrogen/kg bw/day).
• In patients with special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.

D. OVERDOSE

The maximum daily dose varies with the clinical condition of the patient and may change from day to day. The flow rate should be increased gradually during the first hour. The administration flow rate must be adjusted taking into account the dose being administered, the daily volume intake and the duration of the infusion. The recommended infusion period is 14-24 hours.

If hyperglycemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate. Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.

The dosage range of 13-31 ml/kg bw/day will provide 0.7-1.6 g amino acids/kg bw/day (corresponds to 0.11-0.26 g nitrogen/kg bw/day) and 14-33 kcal/kg bw/day of total energy (11-27 kcal/kg bw/day of non-protein energy). The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h. The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.10 g amino acids, 0.25 g glucose and 0.08 g lipids/kg bw/h). The recommended maximum daily dose is 35 ml/kg bw/day which will provide 1.8 g amino acids/kg bw/day (corresponding to 0.29 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.40 g lipids/kg bw/ day and a total energy content of 38 kcal/kg bw/day (corresponding to 30 kcal/kg bw/day of nonprotein energy). Paediatric population There have been no studies performed with FINOMEL 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 should be closely monitored. Method of administration Intravenous use, infusion into a central vein. For instructions on reconstitution of the medicinal product before administration, see section E. Special precautions for disposal and other handling. For information on mixing with other infusions/blood before or during administration, see section C. Incompatibilities.

Omegomel Finomel FOSOMEL

In the event of an overdose, nausea, vomiting, chills, hyperglycemia, and electrolyte disturbances and signs of hypervolemia or acidosis may occur. In such situations, the infusion must be stopped immediately.

If symptoms persist after discontinuing infusion, hemodialysis, hemofiltration or hemodiafiltration may be considered. E. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING To open:

• Remove the protective overpouch.
• Discard the oxygen absorber sachet.
• Use only if the bag is not damaged, the non-permanent seals are intact (i.e., no content mixture of any of the three chambers), the solution in the amino acids chamber and the solution in the glucose chamber are clear, colorless, or slightly yellow, 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 breaking the nonpermanent seals.
• Manually roll the bag onto itself, starting at the top of the bag (hanger end). (Picture 1) The nonpermanent seals will disappear from the side near the inlets. Continue to roll the bag until the seals are open along approximately half of their length. (Picture 2)
• Mix by inverting the bag at least 3 times. (Picture 3)
• After reconstitution, the mixture is a homogeneous emulsion with a milky appearance. After removing the protective cap from the medication port, one can add compatible additives via the medication port. (see "Addition" sub-section) Remove the protector cap from the infusion port and attach the infusion set. Hang the bag on an infusion stand and carry out infusion using the standard technique. (Picture 4) After opening the bag, content should be used immediately, and should not be stored for a subsequent infusion. Do not reconnect any partially used bag. Do not connect in series in order to avoid the possibility of air embolism.

FINOMEL can be mixed with the following additives:

• Multi-vitamin preparations
• Multi-trace element preparations
• Selenium
• Zinc
• Sodium salt
• Potassium salt
• Magnesium salt
• Calcium salt
• Phosphate salt The compatibility indicative table below shows possible additions of multi-trace element product such as Nutryelt and multi-vitamin product such as Cernevit and generics of electrolytes and trace elements in defined quantities. The addition of clinically needed electrolytes and trace elements should take into account the amounts already included in the initial bag formulation. Additive Nutryelt (Composition per vial: Zinc 153 μmol; Copper 4.7 μmol; Manganese 1.0 μmol; Fluorine 50 μmol; Iodine 1.0 μmol; Selenium 0.9 μmol; Molybdenum 0.21 μmol; Chromium 0.19 μmol; Iron 18 μmol) Cernevit (Composition per vial: Vit. A (as Retinol palmitate) 3500 IU, Vit. D3 (Cholecalciferol) 220 IU, Vit. E (Alphatocopherol) 11.2 IU, Vit. C (Ascorbic acid) 125 mg, Vit. B1 (Thiamine) 3.51 mg, Vit. B2 (Riboflavin) 4.14 mg, Vit. B6 (Pyridoxine) 4.53 mg, Vit. B12 (Cyanocobalamin) 6 μg, Vit. B9 (Folic acid) 414 μg, Vit. B5 (Pantothenic acid) 17.25 mg, Vit. B8 (Biotin) 69 μg, Vit. PP (Nicotinamide) 46mg) Sodium Potassium Magnesium Calcium Phosphate (organic such as sodium glycerophosphate) Or Phosphate (mineral such as potassium phosphate) Selenium Zinc

Total content after addition for all bag sizes of FINOMEL 2 vialsa/bag

2 vialsb/bag

138 mmol/L 138 mmol/L 5 mmol/L 4.6 mmol/L 18.5 mmol/L 5.5 mmol/L 7.6 μmol/L 0.31 mmol/L

a Volume of vial: 10mL concentrate solution b Volume of vial: 5 mL lyophilisate

C. INCOMPATIBILITIES

Compatibility may vary between products from different sources and health care professionals are advised to carry out appropriate checks when mixing FINOMEL with other parenteral solutions.

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

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

Ceftriaxone must not be mixed or administered simultaneously with intravenous calcium containing solutions, including FINOMEL.

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

FINOMEL should not be administered simultaneously with blood through the same infusion tubing.

Addition should be made aseptically.

When making additions, the final osmolarity of the admixture must be assessed.

4511208-1902-001

Contents of the pack and other information

(intravenous catheter) is placed in your vein. Your doctor will carefully watch you for any signs of

rashes, wheals (raised red areas), flushing, headache).

The glucose and amino acid solutions are clear and colourless to slightly yellow, and free from particles.

infection. Using "aseptic technique" ("germ free") when placing and maintaining the catheter and

• Refeeding syndrome (a disease that develop when receiving feeding after long periods of fasting)

The lipid emulsion is white and homogenous.

when making the nutritional formula can reduce the risk of infection.

• Elevated blood sugar levels (Hyperglycemia)