infusion solution, emulsion
1. What Finomel Perifer is and what it is used for
Finomel Peripheral containing amino acids (protein building blocks), glucose(carbohydrates), lipid s (fats), and salts ( electrolyte s).
Finomel Peripheral is used to provide nutrition to adults through a tube into a vein ( infusion ) when the normal nutritional intake by mouth is inadequate or inappropriate.
2. What you need to know before using Finomel Peripheral
Do not use Finomel Peripheral
- 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 Peripheral 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 Peripheral, 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 Peripher in children and adolescents.
Other medicines and Finomel Peripheral
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Finomel Peripheral 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 Peripheral contains 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. Data on the use of Finomel Peripheral during pregnancy or breastfeeding women. Use of Finomel Peripheral may be considered during pregnancy and breastfeeding unless your doctor feels it.
Driving and using machines
Not relevant as the medicine is given in a hospital.
3. How to use Finomel Peripheral
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 Peripheral will be given to you by a healthcare professional.
Use for children
The safety and efficacy of Finomel Peripheral in children and adolescents below 18 years have not been established.
If you use more Finomel Peripher then you should
It’s not likely to get too much medicine because Finomel Peripheral is given to you by a healthcare professional.
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 ( hyperglycaemia )
- 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 Perifer
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 | 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 |
| Prolin | 2.14 |
| Serin | 1.58 |
| Treonin | 1.32 |
| Tryptophan | 0.57 |
| Tyrosine | 0.13 |
| Valin | 1.83 |
| Sodium acetate trihydrate | 1.77 |
| Potassium chloride | 1.41 |
| Calcium chloride dihydrate | 0.23 |
| Magnesium sulfate heptahydrate | 0.78 |
| Sodium glycerophosphate, hydrated | 1.87 |
| Zinc sulfate heptahydrate | 0.007 |
| Glucose (as monohydrate) | 77.8 |
| Soybean oil, refined | 8.46 |
| Olive oil, refined | 7.05 |
| Medium chain triglyceride s | 7.05 |
| Fish oil, rich in omega-3 acids | 5.64 |
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 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 1450 ml
4 x 2020 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
This leaflet was last modified on January 24, 2019
The following information is intended for healthcare professionals only:
A. QUALITATIVE AND QUANTITATIVE COMPOSITION
Finomel Peripheral provided in a plastic bag with 3 sections ( three-chamber bag ). Each bag contains a sterile non-pyrogenic combination of 13% glucose solution, 10% amino acid solution with electrolytes and 20% lipid emulsion.
Composition of the reconstituted emulsion one after mixing the three sections:Show larger
| Active substances | 1085 ml | 1450 ml | 2020 ml |
| Fish oil, rich in omega-3 acids | 6.12 g | 8.16 g | 11.40 g |
| Olive oil, refined | 7.65 g | 10.20 g | 14.25 g |
| Soybean oil, refined | 9.18 g | 12.24 g | 17.10 g |
| Medium chain triglyceride s | 7.65 g | 10.20 g | 14.25 g |
| Alanine | 7.08 g | 9.46 g | 13.17 g |
| Arginine | 3.93 g | 5.26 g | 7.31 g |
| Glycine | 3.52 g | 4.71 g | 6.55 g |
| Histidine | 1.64 g | 2.19 g | 3.05 g |
| Isoleucine | 2.05 g | 2.74 g | 3.82 g |
| Leucine | 2.50 g | 3.34 g | 4.64 g |
| Lysine (as lysine hydrochloride) | 1.98 g (2.48 g) | 2.65 g (3.31 g) | 3.69 g (4.61 g) |
| Methionine | 1.37 g | 1.83 g | 2.54 g |
| Phenylalanine | 1.92 g | 2.56 g | 3.56 g |
| Prolin | 2.33 g | 3.11 g | 4.32 g |
| Serin | 1.71 g | 2.29 g | 3.18 g |
| Treonin | 1.44 g | 1.92 g | 2.67 g |
| Tryptophan | 0.62 g | 0.82 g | 1.14 g |
| Tyrosine | 0.14 g | 0.18 g | 0.25 g |
| Valin | 1.98 g | 2.65 g | 3.69 g |
| Sodium acetate trihydrate | 1.92 g | 2.57 g | 3.57 g |
| Potassium chloride | 1.53 g | 2.05 g | 2.85 g |
| Calcium chloride dihydrate | 0.25 g | 0.34 g | 0.47 g |
| Magnesium sulfate heptahydrate | 0.84 g | 1.13 g | 1.57 g |
| Sodium glycerophosphate, hydrated | 2.03 g | 2.71 g | 3.77 g |
| Zinc sulfate heptahydrate | 0.008 g | 0.011 g | 0.015 g |
| Glucose (as glucose monohydrate) | 76.7 g (84.4 g) | 102.6 g (111.8 g) | 142.9 g (157.2 g) |