infusion solution, emulsion 

1. What Finomel is and what it is used for

Finomel contains amino acids (building blocks of proteins), glucose (carbohydrates), lipids (fats), and salts ( electrolytes ).

Finomel is used to nourish adults through a tube in a vein ( infusion ) when normal oral intake of food is insufficient or inappropriate.

2. What you need to know before using Finomel

Do not use Finomel

  • If you are allergic to fish, egg, soy, peanut protein, or corn/corn products (see also section “Warnings and precautions” below) or 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 disease.
  • If you have problems affecting blood clotting (coagulation disorder).
  • If you have a disorder of the body’s ability to convert and break down amino acids.
  • If you have severe kidney disease.
  • If you have too much sugar in your blood.
  • If you have an abnormally high concentration in the blood of any electrolyte ( sodium, potassium, magnesium, calcium, and/or phosphorus).
  • If you have problems getting large volumes of fluid in the vein (via a drip) such as acute pulmonary edema, hyperhydration (overhydration), and untreated heart failure.
  • If you have acute and serious health problems e.g. after severe injuries, untreated diabetes, heart attack, stroke, blood clot, metabolic acidosis (a metabolic disorder that produces too much acid in the blood), blood poisoning (bacteria in the blood), hypotonic dehydration (dehydration caused by low blood pressure ) or hyperosmolar coma (unconsciousness ).

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

Warnings and cautions

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

  • Serious kidney problems. Also, tell your doctor if you are receiving dialysis or any other type of blood purification.
  • Serious liver problems.
  • Problems with blood coagulation (blood clotting ability).
  • Adrenal glands that do not function properly (adrenal insufficiency). The adrenal glands are triangular glands located on top of the kidneys.
  • Heart failure.
  • Lung disease.
  • Water accumulation in the body (hyperhydration).
  • Insufficient amount of water in the body ( dehydration ).
  • Untreated high blood sugar ( diabetes mellitus ).
  • Heart attack or shock due to sudden heart failure.
  • Severe metabolic acidosis (when the blood is too acidic).
  • A serious infection (blood poisoning).

The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction (such as fever, chills, rash, or difficulty breathing) develop. This medicine contains fish oil, soybean oil, egg phosphatide proteins, and the glucose produced from maize, which may cause hypersensitivity reactions. Cross-allergic reactions between soybeans and peanut protein have been observed.

Breathing difficulties can also be a sign that small particles have formed that block blood vessel in the lungs (precipitation in the pulmonary vessels). If you experience difficulty breathing, talk to a doctor or nurse. They will decide on appropriate measures.

If during infusion you notice pain, burning sensation, stiffness, swelling, or discoloration of the skin at the infusion site, or if the infusion is leaking, tell your doctor or nurse. Infusion one is stopped immediately and started in another vein.

The risk of infection or sepsis (bacteria or toxins in the blood) is particularly high when a tube ( intravenous catheter ) is inserted into the vein. Your doctor will monitor you closely and pay attention to any signs of infection. The risk of infection can be reduced by using the “aseptic technique” (“bacteria-free technique”) when placing and caring for the catheter and when preparing the nutrient solution.

Fat overload syndrome has been reported for similar drugs. If your body has a reduced or decreased ability to get rid of the fats in Finomel, fat overload syndrome may occur (see section 4 – Possible side effects ).

If you are severely malnourished and need nutrition through a vein, it is recommended that parenteral nutrition (nutrition through a tube in the vein) be started slowly and carefully.

Additional samples for monitoring

The balance between water and electrolytes in the body and metabolic disorders should be corrected before the infusion begins. To monitor the effect and continuously monitor the safety of the infusion, your doctor may perform clinical and laboratory tests while you are receiving this medicine. Your doctor will monitor your condition and may change your dose or give you additional medicines.

Children and young people

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

Other medicines and Finomel

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

Finomel contains calcium. It must not be given together with or through the same tube as ceftriaxone (an antibiotic ) as particles can then form. If the same tubing is used to give you these medicines one after the other, it should be rinsed thoroughly.

Olive and soybean oil in Finomel include K vitamin. This does not normally affect blood thinners ( anticoagulants ) such as coumarin, but you should tell your doctor if you are taking blood thinners.

The fats in this mixture may affect the results of some laboratory tests if blood samples are taken before the fats have disappeared from your bloodstream (usually they have disappeared 5 to 6 hours after the end of the infusion ).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. No data are available from the use of Finomel during pregnancy and lactation. The use of Finomel may be considered during pregnancy and breast-feeding if your doctor considers it.

Driving and using machines

Not relevant as the medicine is given in a hospital.

3. How to use Finomel

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

This medicine is given as an intravenous infusion via a tube ( catheter ) into a vein.

Your doctor will adjust the dosage individually for you based on your body weight and body function. Finomel will be given to you by healthcare professionals.

Use for children

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

If you use more Finomel than you should  

It is unlikely that you will be given too much medicine, as Finomel is given to you by healthcare professionals.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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 (affects an unknown number of users):

  • Hypersensitivity reactions (may cause symptoms such as swelling, fever, drop in blood pressure, rash, hives (raised red areas), redness, headache)
  • Feedback syndrome (a condition that develops when one is nourished after long periods of fasting)
  • Elevated blood sugar levels (hyperglycemia)
  • Dizziness
  • Headache
  • Venous inflammation ( thrombophlebitis )
  • Blood clots in the lungs
  • Breathing difficulties
  • Nausea
  • Vomiting
  • Slightly elevated body temperature
  • Elevated plasma levels of liver enzymes
  • Fat overload syndrome
  • Leakage of infusion fluid to surrounding tissue (extravasation).

5. How to store Finomel

Keep this medicine out of the sight and reach of children.

Store in the outer bag. Do not freeze.

Do not use this medicine after the expiry date which is stated on the bag and carton after EXP. The expiration date is the last day of the specified month.

Do not use this medicine if you notice visible particles or 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

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
Serin 2.54
Troponin 2.13
Tryptophan 0.91
Tyrosine 0.20
Valin 2.95
Sodium acetate trihydrate 2.85
Potassium chloride 2.28
Calcium chloride dihydrate 0.38
Magnesium sulfate heptahydrate 1.25
Sodium glycerophosphate, hydrated 3.01
Zinc sulfate heptahydrate 0.012
Glucose (as monohydrate) 139.5
Soybean oil, refined 11.40
Olive oil, refined 9.50
Medium chain triglyceride s 9.50
Fish oil, rich in omega-3 acids 7.60
  • The other ingredients are concentrated acetic acid, hydrochloric acid, egg phospholipids, glycerol, sodium oleate, all-rac-α-Tocopherol, sodium hydroxide, water for injections.

What the medicine looks like and the contents of the pack

The glucose and amino acid solutions are clear, colorless, or slightly yellow and particle-free. The fat emulsion is white and homogeneous.

The appearance of the mixture after the three separate chambers are mixed is a white emulsion.

Pack sizes:

4 x 1085 ml

4 x 1435 ml

4 x 1820 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Baxter Medical AB

Box 63

164 94 Kista

Manufacturer:

Baxter SA

Boulevard René Branquart 80

7860 Lessines

Belgium

Muhammad Nadeem

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