Nutriplus Omega
Italy
Table of Contents
Package leaflet: Information for the user
Nutriplus Omega
Emulsion for infusion
Read this leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, 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 reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Nutriplus Omega is and what it is used for.
- What you need to know before using Nutriplus Omega.
- How to use Nutriplus Omega.
- Possible side effects.
- How to store Nutriplus Omega.
- Package contents and other information.
1. What Nutriplus Omega is and what it is used for
Nutriplus Omega contains liquids and substances called amino acids, electrolytes, and fatty acids, which are essential for growth or recovery of the body. It also provides calories in the form of carbohydrates and fats.
Nutriplus Omega is administered when an individual is unable to eat food normally. There are many situations that may require this type of nutritional support, for example, during recovery after surgery, following injuries or burns, or when a person is unable to absorb nutrients from the stomach and intestines.
This solution is intended for use in adults.
2. What you need to know before using nutriplus omega
Do not use Nutriplus Omega
If you are allergic to any of the active substances, egg, peanuts, soybean seeds, fish, or to
any of the other components of this medicinal product (listed in section 6).
This medicinal product must not be used in neonates, infants, and children under two years
of age.
In addition, do not use Nutriplus Omega if you have any of the following conditions:
Circulatory problems with life-threatening risk, such as those that may occur
if you are in a state of shock or collapse
Heart attack or stroke
Severe blood coagulation disorders, risk of bleeding (severe coagulopathy,
worsening haemorrhagic diathesis)
Obstruction of blood vessels due to blood clots or fats (embolism)
Severe liver insufficiency
Impaired bile flow (intrahepatic cholestasis)
Severe renal insufficiency without haemofiltration or dialysis
Disturbances in the body's electrolyte balance
Lack of fluids or excessive accumulation of water in the body
Presence of water in the lungs (pulmonary edema)
Severe heart failure
Some metabolic disorders such as:
- excessive accumulation of lipids (fats) in the blood (severe hypertriglyceridemia);
- inherited disorders of amino acid metabolism;
- unusually high blood sugar levels requiring more than 6 units of insulin per hour to be controlled;
- metabolic abnormalities that may occur after surgery or injury;
- coma of unknown origin;
- insufficient oxygen supply to tissues;
- abnormally high acid levels in the blood.
Warnings and precautions
Talk to your doctor before using Nutriplus Omega
Inform your doctor if:
You suffer from heart, liver, or kidney problems
You suffer from certain metabolic disorders such as diabetes, altered fat levels in
the blood, or disturbances in the body's fluid and salt balance or acid-base equilibrium
If you take this medicinal product, you will be closely monitored to detect early signs
of an allergic reaction (such as fever, chills, rash, difficulty breathing).
Further monitoring and tests, including various types of blood tests, will be performed
to ensure your body is properly utilizing the administered substances.
The nursing staff may also check that your body's fluid and electrolyte requirements
are properly balanced. In addition to Nutriplus Omega, other nutrients (nutritional substances)
may be administered to fully meet your needs.
Children and adolescents
The safety and efficacy in children and adolescents have not been established. This
medicinal product must not be administered to neonates, infants, and children under two years of
age.
Other medicines and Nutriplus Omega
Inform your doctor if you are taking, have recently taken, or might take any other
medicine.
Nutriplus Omega may interact with certain medicines. Inform your doctor if you are taking or
are being treated with the following drugs:
Insulin
Heparin
Medicines that prevent blood clot formation, such as warfarin or other coumarin derivatives
Medicines to increase urine flow (diuretics)
Medicines for treating high blood pressure (ACE inhibitors)
Medicines for treating high blood pressure or heart problems (angiotensin II receptor antagonists)
Medicines used after organ transplantation, such as cyclosporine and tacrolimus
Medicines for treating inflammation (corticosteroids)
Hormones affecting fluid balance in the body (adrenocorticotropic hormone [ACTH]).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicinal product.
If you are pregnant, you will be treated with this medicinal product only if your doctor considers it
absolutely necessary for your recovery. There are no available data on the use of Nutriplus Omega
in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
Nutriplus Omega is normally administered to immobile patients, e.g., in hospital or clinic. This
situation excludes driving vehicles or operating machinery. However, this medicinal product has no effect on the ability to drive or operate machinery.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.
3. How to use nutriplus omega
This medicine is administered by intravenous infusion (i.e. through a small tube directly into a vein). This medicine will only be administered through the main (central) veins.
Your doctor will decide how much medicine you need and for how long you require treatment with this medicine.
Use in children and adolescents
This medicine must not be administered to neonates, infants and toddlers under two years of age. The safety and efficacy in children have not been established.
If you use more Nutriplus Omega than you should
If you have received an excessive amount of this medicine, you may experience the so-called "overload syndrome", with the following symptoms:
- Excessive fluid accumulation and electrolyte disturbances
- Fluid in the lungs (pulmonary edema)
- Loss of amino acids in urine and disruption of amino acid balance
- Vomiting, feeling unwell
- Chills
- High blood sugar levels
- Presence of glucose in urine
- Dehydration
- Increased blood density (hyperosmolality)
- Altered or lost consciousness due to extremely high blood sugar levels
- Enlargement of the liver (hepatomegalia), with or without jaundice
- Enlargement of the spleen (splenomegalia)
- Fat deposition in internal organs
- Abnormal liver function test results
- Reduced number of red blood cells (anaemia)
- Reduced number of white blood cells (leucopenia)
- Reduced number of platelets (thrombocytopenia)
- Increased number of immature red blood cells (reticulocytosis)
- Breakdown of red blood cells (haemolysis)
- Bleeding or tendency to bleed
- Blood coagulation disorders (as evidenced by changes in bleeding time, coagulation time, prothrombin time, etc.)
- Fever
- High levels of fat in the blood
- Loss of consciousness
If any of these symptoms occur, the infusion must be stopped immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects can be serious. If you experience any of the following symptoms,
contact your doctor immediately so that they can stop administration of this
medicine:
Rare (occurs in 1 to 10 patients out of 10,000 treated):
Allergic reactions, for example skin disorders, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing.
Other side effects include:
Uncommon (occurs in 1 to 10 patients out of 1,000 treated):
Feeling unwell, vomiting, loss of appetite.
Rare (occurs in 1 to 10 patients out of 10,000 treated):
Increased tendency to form blood clots
Bluish discoloration of the skin
Shortness of breath
Headache
Hot flushes
Redness of the skin (erythema)
Sweating
Chills
Feeling cold
Elevated body temperature
Drowsiness
Chest, back, bone or lower back pain
Decrease or increase in blood pressure
Very rare (occurs in fewer than 1 patient out of 10,000 treated):
Unusually high levels of fats or sugars in the blood
Elevated levels of acidic substances in the blood
Excessive presence of lipids may lead to fat overload syndrome; for further information see section 3 “If you use more Nutriplus Omega than you should”. Symptoms usually disappear when the infusion is stopped.
Not known (frequency cannot be estimated from the available data):
Reduced number of white blood cells (leukopenia)
Reduced number of platelets (thrombocytopenia)
Impaired bile flow (cholestasis)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store nutriplus omega
Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep the bags in the outer carton to protect from light.
Do not freeze. If accidentally frozen, discard the bag.
Do not use this medicine after the expiry date stated on the label.
6. Contents of the pack and other information
The active substances in the ready-to-use mixture are:
| Upper left compartment (glucose solution) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Glucose monohydrate equivalent to glucose | 132.0 g 120.0 g | 165.0 g 150.0 g | 247.5 g 225.0 g | 330.0 g 300.0 g |
| Disodium hydrogen phosphate dihydrate | 1.872 g | 2.340 g | 3.510 g | 4.680 g |
| Zinc acetate dihydrate | 5.264 mg | 6.580 mg | 9.870 mg | 13.16 mg |
| Upper right compartment (lipid emulsion) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Medium-chain triglycerides | 20.00 g | 25.00 g | 37.50 g | 50.00 g |
| Refined soybean oil | 16.00 g | 20.00 g | 30.00 g | 40.00 g |
| Omega-3 fatty acids | 4.00 g | 5.00 g | 7.50 g | 10.00 g |
| Lower compartment (amino acid solution) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Isoleucine | 2.256 g | 2.820 g | 4.230 g | 5.640 g |
| Leucine | 3.008 g | 3.760 g | 5.640 g | 7.520 g |
| Lysine hydrochloride equivalent to Lysine | 2.728 g 2.184 g | 3.410 g 2.729 g | 5.115 g 4.094 g | 6.820 g 5.459 g |
| Methionine | 1.880 g | 2.350 g | 3.525 g | 4.700 g |
| Phenylalanine | 3.368 g | 4.210 g | 6.315 g | 8.420 g |
| Threonine | 1.744 g | 2.180 g | 3.270 g | 4.360 g |
| Tryptophan | 0.544 g | 0.680 g | 1.020 g | 1.360 g |
| Valine | 2.496 g | 3.120 g | 4.680 g | 6.240 g |
| Arginine | 2.592 g | 3.240 g | 4.860 g | 6.480 g |
| Histidine hydrochloride monohydrate equivalent to Histidine | 1.624 g 1.202 g | 2.030 g 1.503 g | 3.045 g 2.254 g | 4.060 g 3.005 g |
| Alanine | 4.656 g | 5.820 g | 8.730 g | 11.64 g |
| Aspartic acid | 1.440 g | 1.800 g | 2.700 g | 3.600 g |
| Glutamic acid | 3.368 g | 4.210 g | 6.315 g | 8.420 g |
| Glycine | 1.584 g | 1.980 g | 2.970 g | 3.960 g |
| Proline | 3.264 g | 4.080 g | 6.120 g | 8.160 g |
| Serine | 2.880 g | 3.600 g | 5.400 g | 7.200 g |
| Sodium hydroxide | 0.781 g | 0.976 g | 1.464 g | 1.952 g |
| Sodium chloride | 0.402 g | 0.503 g | 0.755 g | 1.006 g |
| Sodium acetate trihydrate | 0.222 g | 0.277 g | 0.416 g | 0.554 g |
| Potassium acetate | 2.747 g | 3.434 g | 5.151 g | 6.868 g |
| Magnesium acetate tetrahydrate | 0.686 g | 0.858 g | 1.287 g | 1.716 g |
| Calcium chloride dihydrate | 0.470 g | 0.588 g | 0.882 g | 1.176 g |
| in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml | |
| Amino acid content [g] | 38 | 48 | 72 | 96 |
| Nitrogen content [g] | 5.4 | 6.8 | 10.2 | 13.6 |
| Carbohydrate content [g] | 120 | 150 | 225 | 300 |
| Lipid content [g] | 40 | 50 | 75 | 100 |
| Electrolytes [mmol] | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Sodium | 40 | 50 | 75 | 100 |
| Potassium | 28 | 35 | 52.5 | 70 |
| Magnesium | 3.2 | 4.0 | 6.0 | 8.0 |
| Calcium | 3.2 | 4.0 | 6.0 | 8.0 |
| Zinc | 0.024 | 0.03 | 0.045 | 0.06 |
| Chloride | 36 | 45 | 67.5 | 90 |
| Acetate | 36 | 45 | 67.5 | 90 |
| Phosphate | 12 | 15 | 22.5 | 30 |
| in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml | |
| Energy content from lipids [kJ (kcal)] | 1590 (380) | 1990 (475) | 2985 (715) | 3980 (950) |
| Energy content from carbohydrates [kJ (kcal)] | 2010 (480) | 2510 (600) | 3765 (900) | 5020 (1200) |
| Energy content from amino acids [kJ (kcal)] | 635 (150) | 800 (190) | 1200 (285) | 1600 (380) |
| Non-protein energy content [kJ (kcal)] | 3600 (860) | 4500 (1075) | 6750 (1615) | 9000 (2155) |
| Total energy content [kJ (kcal)] | 4235 (1010) | 5300 (1265) | 7950 (1900) | 10600 (2530) |
| Osmolality [mOsm/kg] | 1540 |
| Theoretical osmolarity [mOsm/kg] | 1215 |
| pH | 5.0-6.0 |
The other excipients are citric acid monohydrate (for pH adjustment), glycerol, egg lecithin,
sodium oleate, sodium hydroxide (for pH adjustment), all-rac--tocoferol and water for
injections.
Description of the appearance of Nutriplus Omega and pack contents
The ready-to-use product is an infusion emulsion, i.e. it is administered through a tube into a vein.
Nutriplus Omega is supplied in flexible multi-compartment bags containing:
1250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution);
1875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution);
2500 ml (1000 ml amino acid solution + 500 ml lipid emulsion + 1000 ml glucose solution).
The glucose and amino acid solutions are clear and colourless to yellowish. The lipid emulsion is white and milky.
The multi-compartment bag is packaged in a protective overwrap. An oxygen absorber is placed between the bag and the outer packaging.
The two upper compartments are connected to the lower compartment by opening the intermediate seal.
Different volumes are supplied in cartons containing five bags.
Pack sizes: 5x1250 ml, 5x1875 ml and 5x2500 ml
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Str.1 Postal address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Tel: +49-5661-71-0
Fax: +49-5661-71-4567
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Austria NuTRIflex Omega plus
Belgium NuTRIflex Omega plus
Bulgaria NuTRIflex Omega plus
Czech Republic NuTRIflex Omega plus
Estonia NuTRIflex Omega
Finland Nutriflex Omega plus
France Mednutriflex Omega G 120/N 5,4/E
Germany NuTRIflex Omega plus
Hungary NuTRIflex Omega plus
Ireland NuTRIflex Omega plus
Italy Nutriplus Omega
Latvia NuTRIflex Omega
Lithuania NuTRIflex Omega
Luxembourg NuTRIflex Omega plus
Netherlands NuTRIflex Omega plus
Poland NuTRIflex Omega plus
Portugal NuTRIflex Omega P
Romania NuTRIflex Omega plus
Slovakia NuTRIflex Omega plus
Slovenia Nutriflex Omega G 120/N5,4/E
Spain NuTRIflex Omega plus
Sweden NuTRIflex Omega plus
United Kingdom Nutriflex Omega plus
<[Complete with national details]>
The following information is intended exclusively for healthcare professionals:
There are no special requirements for disposal.
Parenteral nutrition products must be visually inspected for any damage, discoloration, and emulsion instability prior to use.
Do not use damaged bags. The overwrap, primary bag, and weld between chambers must be intact. Use only if amino acid and glucose solutions appear clear and colorless to pale yellow, and if the lipid emulsion is homogeneous with a white milky appearance. Do not use if solutions contain particulate matter. After mixing the three chambers, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). Immediately discontinue infusion in case of emulsion discoloration or signs of phase separation.
Preparation of the mixed emulsion:
Remove the inner bag from the protective overwrap and proceed as follows:
Place the bag on a flat, solid surface.
Mix glucose with amino acids by pressing the upper left compartment against the weld, then add the lipid emulsion by pressing the upper right compartment against the weld.
Mix the entire contents of the bag thoroughly.
The resulting mixture appears as a homogeneous oil-in-water emulsion with a white milky appearance.
Preparation for infusion:
The emulsion must always be brought to room temperature before infusion.
Fold the bag and hang it on the infusion stand using the central ring;
remove the protective cap from the infusion port and proceed with standard infusion technique.
For single use only. The container and any unused residues must be discarded after use.
Do not reconnect partially used containers. If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).
Stability period after removal of packaging and mixing of bag contents:
Chemical and physical stability of the mixed amino acids, glucose, and lipids has been demonstrated for 7 days at 2–8 °C and for an additional 2 days at 25 °C.
Stability period after addition of compatible additives:
From a microbiological standpoint, the product should be used immediately after addition of additives. If not used immediately, storage times and conditions prior to use are the responsibility of the user.
The emulsion must be used immediately after opening the container.
The recommended duration of infusion for a parenteral nutrition bag is a maximum of 24 hours.
Nutriplus Omega must not be mixed with medicinal products for which compatibility has not been documented. Nutriplus Omega must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination phenomena.