Leaflet: information for the user

Omegaflex Plus emulsion for infusion

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Omegaflex plus and what it is used for

2. What you need to know before starting to use Omegaflex plus

3. How to use Omegaflex plus

4. Possible side effects

5. Storage of Omegaflex plus

6. Contents of the pack and additional information

Omegaflex plus contains liquids and substances called amino acids, electrolytes, and fatty acids that are essential for the growth or recovery of the body. It also contains calories in the form of carbohydrates and fats.

Omegaflex plusis administered to adults, adolescents, and children over two years old.

Omegaflex plus is administered when there is an inability to ingest food normally.There are many situations in which this can occur, such as, for example, in the recovery phases of surgical interventions, traumas, or burns, or when there is an inability to absorb food in the stomach and intestine.

No use Omegaflex plus

?if you are allergic to any of the active ingredients, egg, peanut, soy, fish, or any of the other components of this medication (listed in section6).

?do not administer this medication to newborns, infants, and children under two years old.

Also, do not useOmegaflex plusif you have any of the following conditions:

?potentially life-threatening blood circulation problems, such as those that may occur in cases of collapse or shock

?heart failure or stroke

?severe blood clotting disorder, risk of bleeding (severe coagulopathy, aggravating hemorrhagic diathesis)

?blockage of blood vessels by blood clots or fat (embolism)

?severe liver insufficiency

?altered bile flow (intrahepatic cholestasis)

?severe kidney insufficiency where dialysis equipment is not available

?alterations in the body's electrolyte composition

?fluid deficiency or excess in the body

?fluid in the lungs (pulmonary edema)

?severe heart failure

?certain metabolic disorders, such as:

–excessive lipids (fats) in the blood

–congenital disorders of amino acid metabolism

–abnormally high blood sugar levels that require more than 6 units of insulin per hour to control

–metabolic alterations that may occur after surgical interventions or trauma

–unknown origin coma

–insufficient oxygen supply to tissues

–abnormally high blood acid levels

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Omegaflex plus.

Inform your doctor if:

?you have heart, liver, or kidney problems

?you present certain types of metabolic disorders, such as diabetes, abnormal blood lipid levels, and disorders in the body's electrolyte and fluid composition or acid-base balance.

You will be closely monitored to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when receiving this medication.

You will undergo additional control and tests, such as various blood sample examinations, to ensure that your body adequately absorbs the administered foods.

The healthcare staff may also take measures to ensure that your body's fluid and electrolyte needs are met. In addition to Omegaflex plus, you may receive additional nutrients (foods) to fully meet your needs.

Children

This medication should not be administered to newborns, infants, and children under two years old.

Use of Omegaflex plus with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Omegaflex plus may interact with some medications. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medications:

?insulin

?heparin

?medications that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives

?medications that promote urine flow (diuretics)

?medications to treat high blood pressure or heart problems (ACE inhibitors and angiotensin II receptor antagonists)

?medications used in organ transplantation, such as cyclosporine and tacrolimus

?medications for treating inflammation (corticosteroids)

?hormonal preparations that affect your body's fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacistbefore using this medication..If you are pregnant, you will receive this medication only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use ofOmegaflex plusin pregnant women.

It is not recommended to breastfeed in mothers treated with parenteral nutrition.

Driving and operating machinery

This medication is usually administered to patients who are bedridden, for example, in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, the medication itself does not affect the ability to drive or operate machinery.

Omegaflexplus contains sodium

This medication contains 0.931mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.047% of the maximum daily sodium intake recommended for an adult.

The maximum daily recommended dose for this medication contains 2607mg of sodium (present in table salt). This is equivalent to 130% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more daily bags for a prolonged period, especially if you have been recommended a low-sodium diet.

This medication is administered through intravenous infusion (drop by drop), that is, through a small tube into a vein. This medication will only be administered through one of your large veins (central). The recommended duration for the infusion of a parenteral nutrition bag is a maximum of 24hours.

Your doctor or pharmacist will decide what amountof this medication you need and for how longyou will needtreatment with it.

Use in children

This medication should not be administered to newborns, infants, and children under two years old.

Your doctor will decide what amount of this medication your child needs and for how long your child will require treatment with this medication.

If you use more Omegaflex plusthan you should

If you have received too much of this medication, you may experience the so-called "overload syndrome" and the following symptoms:

?excess fluids and electrolyte imbalances

?fluid in your lungs (pulmonary edema)

?loss of amino acids through urine and imbalances in amino acid levels

?vomiting, nausea

?chills

?high blood sugar levels

?glucose in urine

?dehydration

?blood that is much more concentrated than normal (hyperosmolality)

?altered or loss of consciousness due to extremely high blood sugar levels

?enlargement of the liver (hepatomegaly) with or without ictericia

?enlargement of the spleen (splenomegaly)

?deposition of fat in internal organs

?abnormal values in liver function tests

?reduction in red blood cell count (anemia)

?reduction in white blood cell count (leucopenia)

?reduction in platelet count (thrombocytopenia)

?increase in immature red blood cells (reticulocytosis)

?rupture of blood cells (hemolysis)

?bleeding or tendency to bleed

?alterations in blood coagulation (as can be seen by changes in bleeding time, coagulation time, prothrombin time, etc.)

?fever

?high levels of fats in the blood

?loss of consciousness

If any of the following symptoms occur, the infusion should be stopped immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medicine:

Rare (may affect up to 1 in 1,000 people):people):

?allergic reactions such as, for example, skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing

Other side effects include:

Possible (may affect up to 1 in 100people):

?nausea,vomiting, loss of appetite

Rare (may affect up to 1 in 1,000people):

?increased tendency of blood coagulation

?blue discoloration of the skin

?shortness of breath

?headache

?flushing

?redness of the skin (erythema)

?sweating

?chills

?sensation of cold

?high body temperature

?drowsiness

?chest, back, bone, or lumbar region pain

?decrease or increase in blood pressure

Very rare (may affect up to 1 in 10,000people):

?abnormally high levels of sugar or fat in the blood

?high levels of acidic substances in your blood

?an excess of lipids may cause overload syndrome; for more information, consult the heading, “If you use more Omegaflex plus than you should” in section3. Symptoms usually disappear when infusion is interrupted.

Frequency not known (cannot be estimated from available data):

?decrease in white blood cell count (leucopenia)

?decreasein platelet count (thrombocytopenia)

?bile flow alterations (cholestasis)

Reporting of side effects

If you experience any type of side effect, consult yourdoctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use.Website:www.notificaRAM.es

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

Do not store above25°C..

Do not freeze. Discard the bag if it has been accidentally frozen.

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

Store the bag in the outer packaging to protect it from light.

Composition ofOmegaflex plus

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

The other components are citric acid monohydrate (for pH adjustment), egg yolk injectable phospholipids, glycerol, sodium oleate, all-rac-alpha-tocopherol, sodium hydroxide (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the container

The ready-to-use product is an emulsion for perfusion, i.e., it is administered through a small tube in a vein.

Omegaflex plus is supplied in flexible multi-chamber bags that contain:

?1.250ml (500ml of amino acid solution + 250ml of fat emulsion + 500ml of glucose solution)

?1.875ml (750ml of amino acid solution + 375ml of fat emulsion + 750ml of glucose solution)

?2.500ml (1.000ml of amino acid solution + 500ml of fat emulsion + 1.000ml of glucose solution)

FigureAFigureB

FigureA: The multi-chamber bag is introduced into a protective wrapper. Between the bag and the wrapper are an oxygen absorber and an oxygen indicator; the wrapper of the oxygen absorber is made of an inert material and contains iron hydroxide.

FigureB: The upper chamber contains a glucose solution, the middle chamber contains a fat emulsion, and the lower chamber contains an amino acid solution.

The glucose and amino acid solutions are clear and colorless to light yellow in color. The fat emulsion is white and milky in color.

The upper and middle chambers can be connected to the lower chamber by opening the intermediate seams.

The different container sizes are presented in boxes containing five bags.

Container sizes: 5x1.250ml, 5x1.875ml, and 5x2.500ml

Only some container sizes may be commercially available.

Holder of the marketing authorization and manufacturer

B. Braun Melsungen AG

Carl‑Braun‑Straße 1Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

Phone: +49-5661-71-0

Fax: +49-5661-71-4567

For more information about this medication, please contact the local representative of the marketing authorization holder

B. Braun Medical, S.A.

Ctra. de Terrasa, 121

08191 Rubí