NUTRIPLUS 1250 ML Emulsion for intravenous infusion

Зміст інструкції

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

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 only for you. Do not give it to other people, even if their
symptoms are the same as yours, as it could be dangerous.
If any undesirable effects occur, including those not listed in this leaflet,
ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Nutriplus Omega and what is it used for

Nutriplus Omega contains liquids and substances called amino acids, electrolytes and fatty acids, which are
essential for growth or the restoration of the body. It also contains 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 nutrition, for example
when a person is recovering after surgery, or following wounds or burns, or
when they are unable to absorb food from the stomach and intestines.
This solution is administered to 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 ingredients, to eggs, peanuts, soy seeds or fish, or to
any of the other ingredients of this medicine (listed in section 6).
This medicine should not be used in newborns, infants and toddlers under two years of
age.
Also, do not use Nutriplus Omega if you have any of the following conditions:
Problems with blood circulation, life-threatening as those that may occur
if you are in a state of shock or collapse
Heart attack or stroke
Severe blood clotting disorders, risk of bleeding (severe coagulopathy,

worsening hemorrhagic diathesis)
Blockage of blood vessels due to blood clots or fat (embolism)
Severe liver failure
Impaired bile flow (intrahepatic cholestasis)
Severe kidney failure without recourse to hemofiltration or dialysis
Disorders of the body's salt 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 control;
• metabolic abnormalities that can occur after surgery or injury;
• coma of unknown origin;
• insufficient oxygen supply to the tissues;
• unusually high acid levels in the blood.

Warnings and precautions
Talk to your doctor before using Nutriplus Omega
Tell your doctor if:
You suffer from heart, liver or kidney problems
You suffer from some metabolic disorders such as diabetes, alteration of the level of fats in the
blood and disorders of the balance of fluids and salts in the body or its acid-base balance
If you take this medicine, you will be carefully monitored to detect early signs of an allergic reaction (such as fever, chills, rash, difficulty breathing).
Further checks and tests will then be performed, such as different types of blood tests, to
ensure that your body uses the administered substances correctly.
The nursing staff may also check that your body's fluid and electrolyte needs are properly balanced. In addition to Nutriplus Omega, you may also be given other nutrients (food substances) to fully cover your needs.

Children and adolescents
Safety and efficacy in children and adolescents have not been established. This
medicine should not be given to newborns, infants and toddlers under two years of
age.

Other medicines and Nutriplus Omega
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

Nutriplus Omega can interact with some medicines. Tell 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 promote urine flow (diuretics)
Medicines for the treatment of high blood pressure (ACE inhibitors)
Medicines for the treatment of high blood pressure or heart problems (angiotensin II receptor antagonists)
Medicines used after transplants such as cyclosporine and tacrolimus
Medicines for the treatment of inflammation (corticosteroids)
Hormones that affect the balance of fluids in the body (adrenocorticotropic hormone
[ACTH]).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
If you are pregnant, you will be treated with this medicine only if your doctor believes it is
absolutely necessary for your recovery. There are no data available on the use of Nutriplus Omega
in pregnant women.
Breastfeeding is not recommended for mothers undergoing 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 and using machinery. However, this
medicine has no effect on the ability to drive vehicles or use machinery.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

3. How to use nutriplus omega

This medicine is administered via intravenous infusion (drip), i.e. through a small tube directly into a vein. This medicine will only be administered through the main (central) veins.
The doctor will decide how much medicine you need to take and for how long you need treatment with this medicine.

Use in children and adolescents
This medicine should not be administered to newborns, infants and toddlers under the age of two years. Safety and efficacy in children have not been established.

If you use more Nutriplus Omega than you should

If you have received too much of this medicine, you may suffer from the so-called “overload syndrome”, with the following symptoms:
Excessive fluid accumulation and electrolyte disturbances
Presence of water in the lungs (pulmonary edema)
Loss of amino acids in the urine and alteration of amino acid balance
Vomiting, feeling unwell
Chills
Elevated blood sugar levels
Presence of glucose in the urine
Lack of fluids in the body
Increased blood density (hyperosmolarity)
Alteration or loss of consciousness due to extremely high blood sugar levels
Enlargement of the liver (hepatomegaly) with or without jaundice
Enlargement of the spleen (splenomegaly)
Fat deposition in internal organs
Alteration of liver function test values
Reduction in the number of red blood cells (anemia)
Reduction in the number of white blood cells (leukopenia)
Reduction in the number of platelets (thrombocytopenia)
Increase in immature red blood cells (reticulocytosis)
Red blood cell breakdown (hemolysis)
Bleeding or tendency to bleed
Blood clotting disorders (as can be observed from changes in bleeding time, coagulation time, prothrombin time, etc.)
Fever
Elevated 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 gets them.

The following side effects may be serious. If you experience any of the following symptoms,
contact your doctor immediately so that they can stop administering this
medicine:
Rare (may affect up to 1 in 10,000 people):
Allergic reactions, for example skin conditions, shortness of breath, swelling of the lips,
mouth and throat, difficulty breathing.

Other side effects include:
Uncommon (may affect up to 1 in 100 people):
Feeling unwell, vomiting, loss of appetite.
Rare (may affect up to 1 in 10,000 people):
Increased tendency to form blood clots
Bluish discoloration of the skin
Shortness of breath
Headache
Hot flashes
Skin redness (erythema)
Sweating
Chills
Feeling cold
Elevated body temperature
Drowsiness
Pain in the chest, back, bones or lower back
Decrease or increase in blood pressure
Very rare (may affect less than 1 in 10,000 people):
Unusually high levels of fats or sugars in the blood
High levels of acidic substances in the blood
An excessive presence of lipids can lead to fat overload syndrome; for
more information on this, 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 available data):
Decreased number of white blood cells (leukopenia)
Decreased number of platelets (thrombocytopenia)
Impaired bile flow (cholestasis)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. 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 at a temperature not exceeding 25 °C. Keep the bags in the outer carton to protect them
from light.

Do not freeze. If accidentally frozen, discard the bag.
Do not use this medicine after the expiry date which is stated on the label.

6. Contents of the pack and other information

The active ingredients in the ready-to-use mixture are:

The other excipients are citric acid monohydrate (for pH adjustment), glycerol, egg lecithin, sodium oleate, sodium hydroxide (for pH adjustment), all-rac-α-tocopherol and water for injections.

Description of the appearance of Nutriplus Omega and contents of the pack
The ready-to-use product is an emulsion for infusion, i.e. it is administered through a tube into a vein.
Nutriplus Omega is supplied in flexible multi-chamber bags containing:
1250 ml (500 ml of amino acid solution + 250 ml of lipid emulsion + 500 ml of
glucose solution);
1875 ml (750 ml of amino acid solution + 375 ml of lipid emulsion + 750 ml of
glucose solution);
2500 ml (1000 ml of amino acid solution + 500 ml of lipid emulsion + 1000 ml of
glucose solution).
The glucose and amino acid solutions are clear and colorless to straw yellow. The lipid
emulsion is milky white.
The multi-chamber bag is packaged in a protective wrapper. An oxygen absorber is
positioned between the bag and the outer packaging.
The two upper compartments are connected to the lower compartment by opening the intermediate weld.
The different volumes are supplied in cartons containing five bags.
Packs: 5x1250 ml, 5x1875 ml and 5x2500 ml
Not all pack sizes may be 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 with the
following denominations:
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 data]>

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 before use.
Do not use damaged bags. The outer packaging, the primary bag and the weld between the chambers
must be intact. Use only if the amino acid and glucose solutions appear clear and
colorless to straw yellow and if the lipid emulsion is homogeneous with a milky white
appearance. Do not use if the 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). Stop the infusion immediately if the emulsion discolors or shows signs of
phase separation.

Preparation of the mixed emulsion:
Remove the inner bag from the protective outer packaging and proceed as follows:
Place the bag on a flat, solid surface.
Mix the glucose with the 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 all the contents of the bag.
The mixture appears as an oil-in-water emulsion with a homogeneous milky white appearance.

Preparation of the infusion:
The emulsion must always be brought to room temperature before infusion.
fold the bag and hang it on the infusion stand via the central ring;
remove the protective cap from the infusion port and proceed with the infusion using the
standard technique.
For single use only. The container and any unused residue must be disposed of after use.
Do not reconnect partially used containers. If filters are used, they must
be permeable to lipids (pore size ≥1.2 µm).

Shelf life after removal of packaging after mixing the bag contents:
The physico-chemical stability after opening the mixture of amino acids, glucose and lipids has been
demonstrated for 7 days at 2-8 °C and for a further 2 days at 25 °C.

Shelf life after addition of compatible additives:

From a microbiological point of view, the product must be used immediately after
addition of additives. If not used immediately after the addition of additives, the storage times and conditions before use are the responsibility of the user.
The emulsion must be used immediately after opening the container.
The recommended infusion duration for a parenteral infusion bag is a maximum of 24 hours.
Nutriplus Omega must not be mixed with other 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.