Leaflet: information for the user

Lipoflex plus emulsion for infusion EFG

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 isLipoflex plusand what it is used for

2. What you need to know before starting to useLipoflex plus

3. How to useLipoflex plus

4. Possible side effects

5. Storage ofLipoflex plus

6. Contents of the pack and additional information

Lipoflex 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.

This medication 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.

This emulsion can be administered to adults, adolescents, and children over 2 years of age.

No use Lipoflex plus

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

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

Similarly, do not use this medication if you have any of the following conditions:

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

?myocardial infarction or cerebrovascular accident,

?severe coagulation disorder, risk of hemorrhage (severe coagulopathy, aggravating hemorrhagic diathesis),

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

?severe hepatic insufficiency,

?altered bile flow (intrahepatic cholestasis),

?severe renal insufficiency where dialysis equipment is not available,

?alterations in the body's electrolyte composition,

?fluid deficit or excess in your body,

?fluid in your 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 disorders 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 Lipoflex plus.

Inform your doctor if:

?you have heart, liver, or kidney problems,

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

Your doctor will closely monitor you to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when you receive this medication.

Your healthcare team will also apply additional control and tests, such as various blood sample examinations, to ensure that your body adequately assimilates the administered foods.

The nursing staff may also take measures to ensure that your body's fluid and electrolyte needs are met. In addition to this medication, you may receive additional nutrients (food) to fully meet your needs.

Children

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

Use of Lipoflex plus with other medications

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

Lipoflex 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 coagulation, such as warfarin or other coumarin derivatives,

?diuretics that promote urine flow,

?medications to treat high blood pressure (ACE inhibitors),

?medications to treat high blood pressure or heart problems (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 or ACTH).

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication will only be given to you if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use of Lipoflex plus in pregnant women.

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

Driving and operating machines

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 machines. However, the medication itself does not affect your ability to drive or operate machines.

Lipoflex plus contains sodium

This medication contains 1,150 mg of sodium (main component of table salt) in each 1,250 ml bag. This is equivalent to 58% of the maximum daily sodium intake recommended for an adult.

The maximum daily recommended dose of this medication contains 2,580 mg of sodium (present in table salt). This is equivalent to 129% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more bags per day for an extended period, especially if you have been advised to follow a low-sodium diet.

This medication is administered through intravenous infusion (drop by drop), that is, through a small tube directly into a vein. This medication will only be administered through one of your large veins (central).

Your doctor or pharmacist will decide how much of this medication you need and for how long you will need treatment with it.

Use in children

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

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

If you use more Lipoflex plus than 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,

• Water in your lungs (pulmonary edema),

• Loss of amino acids through urine and imbalances in amino acid balance,

• Vomiting, nausea,

• Chills,

• High blood sugar level,

• Glucose in urine,

• Fluid deficiency,

• Blood much more concentrated than normal (hyperosmolality),

• 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),

• 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),

• Breakdown 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 doubts 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):

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

Other side effects include:

Possibly frequent (may affect up to 1 in 100 people):

?nausea, vomiting, loss of appetite,

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

?increased tendency of blood coagulation,

?blue discoloration of the skin,

?shortness of breath,

?headache,

?flushing,

?erythema,

?swelling,

?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 10,000 people):

?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, see the heading “If you use more Lipoflexplus 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),

?decrease in 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 for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es)

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

Do not store at a temperature above25°C.

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

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

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

Composition ofLipoflex plus

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

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

Aspect of the product and content of the container

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

Lipoflex 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 overwrap 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, and the fat emulsion is white and milky.

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

The design of the bag allows the mixing of amino acids, glucose, lipids, and electrolytes in a single chamber. When the removable seams are opened, a sterile mixture is formed that forms an emulsion.

The different container sizes are presented in boxes that contain five bags.

Container sizes: 5x1.250ml, 5