Leaflet: information for the user

ClinOleic 20% emulsion for perfusion

Refined olive oil and refined soybean oil

Read this leaflet carefully before starting to use the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

In this leaflet:

1. What ClinOleic is and for what it is used
2. What you need to know before starting to use ClinOleic
3. How to use ClinOleic
4. Possible adverse effects
5. Storage of ClinOleic
6. Contents of the container and additional information

In this leaflet ClinOleic 20% will be referred to as ClinOleic

ClinOleicis an emulsion of olive oil (80%) and soybean oil (20%) for perfusion.

ClinOleicis a source of energy and essential fatty acids (fats or lipids) that the body cannot synthesize. ClinOleicis administered directly into the bloodstream, bypassing the digestive system. This method of nutrition (parenteral nutrition) is used when food and drink cannot be taken through the digestive system due to medical reasons.

No use ClinOleic:

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

Warnings and precautions

Special clinical monitoring is required at the beginning of any intravenous infusion.

If any signs of allergic reaction are detected, the infusion will be stopped immediately. These signs include sweating, fever, chills, headache, skin rash, and shortness of breath. This medication contains soy oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-reactions have been observed between soybean and peanut proteins.

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

Certain medications and diseases may increase the risk of developing infections or sepsis (bacteria in the blood). There is a risk of infection or sepsis, especially when a catheter is placed in a vein. Your doctor will closely monitor you for signs of infection. Patients requiring 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" when placing and maintaining the catheter and preparing the nutritional formula can reduce the risk of infection.

Severe liver 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 manages sugars, fats, proteins, or salts (metabolic disorders),
• Severe blood infection (sepsis),
• Severe liver problem,
• Blood clotting disorder,
• Heart attack (myocardial infarction),
• Heart failure,
• Kidney failure,
• Anemia (reduced red blood cells),
• Pulmonary edema (fluid in the lungs).

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

Severe adverse effects, such as respiratory disorders causing a reduction in oxygen in the body (respiratory distress) and conditions causing an elevated amount of acid in the body (metabolic acidosis), have been reported in newborns (neonates) and young children (infants) after a rapid administration of lipids into the blood vessels (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 efficacy and safety of administration, your doctor will perform clinical and laboratory tests while you are receiving this medication.

Children and adolescents

ClinOleic is suitable for use in young children if its use is carefully controlled. ClinOleic has been used for a maximum of 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) must be protected from exposure to light until the end of administration. Exposure of ClinOleic to ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light exposure.

Use of ClinOleic with other medications

Inform your doctor or pharmacist if you are using or have recently used, or may need to use any other medication.

The olive and soy oils present in ClinOleic contain vitamin K. This usually does not affect blood-thinning medications (anticoagulants) such as warfarin. However, if you take anticoagulants, inform 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, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

ClinOleic contains 200 mg/ml of lipids

Your doctor will instruct you on the dosage and rate of administration.

Dosage

Use in Adults:

Your doctor will decide on the appropriate dosage for your clinical situation.

The dosage 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 newborns 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.

Route and form 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 bags and administration equipment) must be protected from exposure to light until the end of administration (see section 2).

If you receive more ClinOleic than you should:

A overdose may cause a reduction in your body's ability to eliminate the lipids in ClinOleic (lipid overload syndrome). In newborns (neonates) and small children (infants), an overdose and/or rapid administration of the lipids contained in ClinOleic in the blood vessels (increased infusion rate) may cause severe side effects, such as respiratory disorders that reduce oxygen in the body (respiratory distress) and conditions that cause an elevated amount of acid in the body (metabolic acidosis). The effects of an overdose are normally reversible when the ClinOleic infusion is stopped (see section 4 Possible adverse effects)

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

If your doctor or nurse forgot to administer ClinOleic

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

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

Like all medicines, ClinOleic can cause side effects, although not everyone will experience them.

If you notice any abnormal signs at the beginning of the infusion, it should be stopped immediately. These signs include sweating, chills, headache (cephalalgia) 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), feeling sick (vomiting).
• Decreased blood pressure.
• Increased blood sugar levels.

The following side effects are infrequent and may affect between 1 and 10 in 1000 patients:

• Decreased white blood cell count (leucopenia).
• Abdominal distension or pain and discomfort in the stomach area.
• Yellowing of the skin and eyes caused by bile duct problems (cholestasis).
• Increased bilirubin levels.
• Increased liver enzymes or triglycerides in the blood.
• Dyspnea.

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

• Decreased platelet count in the blood.
• Chills.
• Allergic reactions including red skin rash, skin itching (urticaria), pruritus.
• Diarrhea.

If you have a reduced ability to eliminate the lipids contained in ClinOleic, a "fat overload syndrome" may appear, which may have been caused by an overdose, but it can also occur at the beginning 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 lipids in the blood (hyperlipidemia)
• Fever
• Filtration of fats to the liver
• Enlargement of the liver (hepatomegaly)
• Anemia
• Decreased white blood cell and platelet count in the blood
• Blood coagulation disorders
• Coma.

All these symptoms are usually reversible when the infusion is stopped

Reporting of 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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) must be protected from exposure to light until the administration is completed (see section 2).

Do not use ClinOleic after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Do not freeze

Store in the protective overbag.

Store in the outer packaging to protect it 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 bag/indicator is included. Before opening the overbag, examine the color of the oxygen indicator fixed to the oxygen absorber. Compare it with the reference color printed next to the OK symbol and described in the printed area of the indicator label. The bag must be discarded after removing the overbag.

Once opened, use immediately.

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

Do not keep an open bag for future use.

Composition of ClinOleic

• For each 100 ml the active principles are:

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

Corresponding to a content of essential fatty acids of 4.00 g

• Characteristics:

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

Osmolarity: 270 mOsmol/l

pH: 6-8

Density: 0.986

• The 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 contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

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

Responsible for manufacturing

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

This medication is authorized in the member states of the European Economic Area with the following names: ClinOleic 20%

Date of the last review of this leaflet:November 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals.

Administration form:

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

Warnings and special precautions for use:

Exposure to light of parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements or vitamins, may 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 must be protected from ambient light until the end of administration.

Special precautions for disposal and other manipulations:

When used in newborns and children under 2 years, it must be protected from exposure to light 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 exposure to light

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