Package Insert: Information for the User

Lipoflex peri emulsion for EFG perfusion

Read this package insert carefully before starting to use this medication, as it contains important information for you.

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

1. What isLipoflex periand how it is used

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

3. How to useLipoflex peri

4. Possible adverse effects

5. Storage ofLipoflex peri

6. Contents of the package and additional information

Lipoflex peri 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 peri

?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 of age.

Similarly, do not use this medication if 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,

?myocardial infarction or cerebrovascular accident,

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

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

?severe liver insufficiency,

?altered bile flow (intrahepatic cholestasis),

?renal 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 levels of acids in the blood.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Lipoflex peri.

Inform your doctor if:

?You have heart, liver, or kidney problems,

?Youpresent 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 doctor 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 (foods) to fully meet your needs.

Children

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

Use of Lipoflex peri with other medications

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

Lipoflex peri 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,

?medications that promote urine flow (diuretics),

?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 the treatment of inflammation (corticosteroids),

?hormonal preparations that affect your 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 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 ofLipoflexperiin 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, this medication itself does not affect the ability to drive or operate machines.

Lipoflexperi contains sodium

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

The maximum daily recommended dose for 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 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 directly into a vein. This medication may be administered through one of its small veins (peripheral) or through one of its large veins (central).

Your doctor or pharmacist will decide how much of this medication you need and for how long you will require 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 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 of 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,

fluid deficit,

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 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 (leukopenia),

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, 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):

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

Other side effects include:

Frequent (may affect up to 1 in 10 people):

?irritation or inflammation of the veins (phlebitis, thrombophlebitis).

Possibly (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,

?redness of the skin (erythema),

?sweating,

?chills,

?feeling of cold,

?high body temperature,

?drowsiness,

?chest pain, back pain, bone pain, or lower back 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 Lipoflex peri than you should” in section 3. 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 side effects

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

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 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 peri

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

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

Aspect of the product and content of the packaging

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

Lipoflex peri 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 in a protective wrapper. Between the bag and the wrapper, there is 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