CLINOLEIC 20% EMULSION FOR INFUSION

2. What you need to know before you use ClinOleic

Do not use ClinOleic:

• if you are allergic (hypersensitive) to egg, soy, or peanut protein or any of the other components of ClinOleic (see section 6 at the end of this leaflet),
• if you have high levels of fat in your blood (severe hyperlipidemia),
• if you have uncorrected metabolic disorders, including lactic acidosis and uncompensated diabetes.

Warnings and precautions

At the start of any infusion into your veins (intravenous infusion), close clinical monitoring is required.

If any signs of an allergic reaction are detected, the infusion should be stopped immediately. These signs include sweating, fever, chills, headache, skin rash, and difficulty breathing (dyspnea). This medicine contains soybean oil and egg phospholipids. Soy and egg proteins can cause hypersensitivity reactions. Cross-allergic reactions have been observed between soybean and peanut proteins.

Your doctor will monitor and control your triglyceride levels (a type of fat in your blood) and blood sugar levels.

Certain medications and diseases can increase the risk of developing infections or sepsis (bacteria in the blood). There is a risk of infection or sepsis, especially when a tube (intravenous catheter) is inserted into a vein. Your doctor will closely monitor you for signs of infection. Patients who require parenteral nutrition (administration of nutrients through a tube inserted into a vein) may be more prone to infections due to their medical condition. The use of "aseptic techniques" ("germ-free") when placing and maintaining the catheter and preparing the nutritional formula can reduce the risk of infection.

Hepatic disorders have been reported in patients receiving intravenous nutrition therapy. If you experience symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, contact your doctor immediately.

Your doctor should be aware if you have:

• severe conditions that affect how the body handles sugars, fats, proteins, or salts (metabolic disorders),
• severe blood infection (sepsis),
• severe liver problems,
• blood coagulation problems,
• heart attack (myocardial infarction),
• heart failure,
• kidney failure,
• reduction of red blood cells (anemia),
• fluid in the lungs.

Tell your doctor if you notice inflammation, sensitivity, and redness at the injection site, as it may be a sign of inflammation (thrombophlebitis).

Serious side effects, such as respiratory disorders that reduce oxygen levels in the body (respiratory distress) and conditions that cause high levels of acid in the body (metabolic acidosis), have been reported in newborns (neonates) and young children (infants) after rapid administration of lipids into the bloodstream (see section 3 If you receive more ClinOleic than you should).

Your doctor will monitor your condition at the start of the infusion, especially if you currently have liver, kidney, adrenal, cardiac, or circulatory problems.

To check the effectiveness and safety of the administration, your doctor will perform clinical and laboratory tests while you are receiving this medicine.

Children and adolescents

ClinOleic is suitable for use in young children if its use is carefully controlled. ClinOleic has been used for up to 7 days in newborns (neonates) and up to 2 months in children.

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) should be protected from light exposure until the end of administration (see section 2).

Using ClinOleic with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

The olive and soybean oils present in ClinOleic contain vitamin K. This usually does not affect blood-thinning medicines (anticoagulants) such as coumarin. However, if you are taking anticoagulants, you should tell your doctor.

Pregnancy and breastfeeding

The safety of administering ClinOleic during pregnancy and breastfeeding has not been established. Therefore, ClinOleic should not be used during pregnancy and breastfeeding, except on the advice of your doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

3. How to use ClinOleic

ClinOleic contains 200 mg/ml of lipids.

Your doctor will decide the dose and rate of administration.

Dose

Adult use:

Your doctor will decide the appropriate dose for your clinical situation.

The dose is 1 to a maximum of 2 g of lipids/kg/day.

Use in children

It is recommended not to exceed a daily dose of 3 g of lipids/kg.

Use in premature newborns and low-birth-weight babies

The use of ClinOleic is limited to small premature children born after at least 28 weeks of gestation or more.

It is recommended not to exceed a daily dose of 2 g of lipids/kg.

Method and route of administration

You will receive ClinOleic through a plastic tube connected to a vein with a needle (intravenous infusion).

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) should be protected from light exposure until the end of administration (see section 2).

If you receive more ClinOleic than you should:

An overdose can cause a reduction in your body's ability to eliminate the lipids in ClinOleic (fat overload syndrome). In newborns (neonates) and young children (infants), an overdose and/or rapid administration of the lipids in ClinOleic into the bloodstream can cause serious side effects, such as respiratory disorders that reduce oxygen levels in the body (respiratory distress) and conditions that cause high levels of acid in the body (metabolic acidosis). The effects of an overdose are usually reversible when the ClinOleic infusion is stopped (see section 4 Possible side effects).

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 915.620.420.

If your doctor or nurse forgets to administer ClinOleic

You should not receive a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, ClinOleic can cause side effects, although not everybody gets them.

If you notice any abnormal signs at the start of the infusion, it should be stopped immediately. These signs include sweating, chills, headache, and difficulty breathing (dyspnea).

Other side effects have been reported, which occur more or less frequently:

The following side effects are common and may affect between 1 and 10 in 100 patients:

• Feeling unwell (nausea), being sick (vomiting).
• Decrease in blood pressure.
• Increase in blood sugar levels.

The following side effects are uncommon and may affect between 1 and 10 in 1,000 patients:

• Decrease in white blood cell count (leucopenia).
• Abdominal distension or pain and discomfort in the stomach area.
• Yellowing of the skin and eyes due to bile duct problems (cholestasis).
• Increased bilirubin levels.
• Increased liver enzyme or triglyceride levels in the blood.
• Difficulty breathing (dyspnea).

The following side effects have also been reported with an unknown frequency:

• Decrease in platelet count.
• Chills.
• Allergic reactions including red skin rash, itching (urticaria), itching.
• Diarrhea.

If you have reduced ability to eliminate the lipids in ClinOleic, a "fat overload syndrome" may occur, which can be caused by an overdose but can also occur at the start of an infusion even if ClinOleic is administered correctly. It is associated with a sudden worsening of the patient's clinical condition. The fat overload syndrome can cause:

• excess fat in the blood (hyperlipidemia)
• fever
• fat filtration to the liver
• enlargement of the liver (hepatomegaly)
• reduction of red blood cells (anemia)
• decrease in white blood cells and platelets in the blood
• blood coagulation disorders
• coma.

These symptoms are usually reversible when the infusion is stopped.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ClinOleic

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

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) should be protected from light exposure until the end of administration (see section 2).

Do not use ClinOleic after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Do not freeze.

Keep in the protective overbag.

Keep in the outer packaging to protect from moisture.

Do not use ClinOleic if the packaging is damaged or if the emulsion is not uniformly milky.

Partially used containers must be discarded. The remaining emulsion must not be reused and must be disposed of by healthcare personnel.

Inside the overbag, an oxygen absorber/sensor bag is included. Before opening the overbag, check the color of the oxygen sensor attached to the oxygen absorber. Compare it with the reference color printed next to the OK symbol and described in the printed area of the sensor label. The bag should be discarded after removing the overbag.

Once opened, use immediately.

Do not use the product if the color of the oxygen sensor does not match the reference color.

Do not keep an opened bag for later use.

6. Contents of the pack and other information

ClinOleic composition

• Per 100 ml, the active ingredients are:

Purified olive oil (80%) and purified soybean oil (20%) 20.00 g

corresponding to an essential fatty acid content of 4.00 g.

• Characteristics:

Energy content: 2000 kcal/l (8.36 MJ/l)

Osmolality: 270 mOsmol/l

pH: 6-8

Density: 0.986

• Other components are: egg phospholipids, glycerol, sodium oleate, sodium hydroxide, and water for injectable preparations.

• The phospholipids provide 47 milligrams or 1.5 mmol of phosphorus per 100 ml.

Appearance of the product and pack contents

ClinOleic is a homogeneous milky liquid.

It is supplied in plastic bags:

100 ml: boxes of 24 or 10 units.

250 ml: boxes of 20 or 10 units.

350 ml: boxes of 12 or 10 units.

500 ml: boxes of 12 or 10 units.

1000 ml: boxes of 6 units.

1 bag of 100/250/350/500/1000 ml.

Not all pack sizes may be marketed.

Marketing authorisation holder

BAXTER, S.L. Polígono Industrial Sector 14. Pouet de Camilo, 2. Ribarroja del Turia (Valencia).

Manufacturer

Baxter S.A., Av. René Branquart 80, Lessines, Belgium.

This medicine is authorised in the Member States of the European Economic Area under the following names:ClinOleic 20%.

Date of last revision of this leaflet:November 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals.

Method of administration:

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) should be protected from light exposure until the end of administration.

Special warnings and precautions for use:

Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with oligoelements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, ClinOleic should be protected from ambient light until the end of administration.

Special precautions for disposal and other handling:

For single use.

• Open

• Tear the protective overbag.
• Discard the oxygen absorber/sensor.
• Check the integrity of the bag.
• Use only if the bag is not damaged and if the emulsion is a homogeneous milky liquid.

• Preparation for administration

• Hang the bag
• Remove the plastic protector from the administration outlet
• Firmly insert the infusion set spike into the administration outlet

• Additions

Do not make additions directly to the bag.

The lipids present are only one component of parenteral nutrition. For complete parenteral nutrition, concomitant substitution with amino acids, carbohydrates, electrolytes, vitamins, and oligoelements is necessary. Before administration to the patient, the compatibility of the components and the stability of the mixture should be verified. This should be accompanied by gentle agitation during preparation and should only be done under strict aseptic conditions.

• Administration

After opening the bag, the contents should be used immediately. The opened bag should never be stored for later infusion. Do not reconnect partially used bags.

Do not connect bags in series to avoid gas embolism due to possible residual air drawn from the primary container.

Do not use if particles or agglomerates are observed in the solution.

The unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations.

When used in newborns and children under 2 years, it should be protected from light exposure until the end of administration. Exposure of ClinOleic to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light exposure.