Clinoleic 20% emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ClinOleic 20% emulsion for infusion

Refined olive oil and refined soya oil

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

In this leaflet:

1. What ClinOleic is and what it is used for
2. What you need to know before using ClinOleic
3. How to use ClinOleic
4. Possible side effects
5. How to store ClinOleic
6. Contents of the pack and other information

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

1. What Clinoleic is and what it is used for

ClinOleic is an 80% olive oil and 20% soybean oil emulsion for infusion.

ClinOleic provides energy and essential fatty acids (fats or lipids) that cannot be synthesized by the body. ClinOleic is administered directly into the bloodstream, bypassing the digestive system. This method of feeding (parenteral nutrition) is used when food and drink cannot be taken through the digestive system for medical reasons.

2. What you need to know before using ClinOleic

Do not use ClinOleic:

• if you are allergic (hypersensitive) to egg, soybean protein, 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 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 (intravenous perfusion).

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

Your doctor will monitor and control your triglyceride levels (a type of fat in your blood) and your 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 tube (intravenous catheter) is placed in the 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" ("germ-free" techniques) when placing and maintaining the catheter and when preparing the nutritional formula can reduce the risk of infection.

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

Your doctor should know if you have:

• serious conditions affecting how your body handles sugars, fats, proteins, or salts (metabolic disorders),
• severe blood infection (sepsis),
• serious liver disease,
• blood clotting disorder,
• heart attack (myocardial infarction),
• heart failure,
• kidney failure,
• reduced red blood cells (anemia),
• presence of fluid in the lungs.

Inform your doctor if you develop swelling, tenderness, or redness at the injection site, as this may be a sign of inflammation (thrombophlebitis).

Serious adverse effects, such as respiratory disorders causing reduced oxygen in the body (respiratory distress) and conditions leading to high levels of acid in the body (metabolic acidosis), have been reported in newborns (neonates) and young children (infants) after rapid intravenous administration of lipids (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, heart, or circulatory problems.

To monitor the effectiveness and safety of 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 of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete. Exposure of ClinOleic to ambient light, especially after mixing with trace elements or vitamins, may generate peroxides and other degradation products, which can be minimized by protecting the product from light exposure.

Use of ClinOleic with other medicines

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

The olive and soybean oils in ClinOleic contain vitamin K. This usually does not affect blood-thinning medications (anticoagulants) such as coumarin. However, if you are taking anticoagulants, you must 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, 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 determine the dose and rate of administration.

Dosage

Use in Adults:

Your doctor will decide the appropriate dose for your clinical condition.
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 Preterm Newborns and Low-Birth-Weight Infants:

The use of ClinOleic is limited to premature infants 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 Method 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 of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).

If you receive more ClinOleic than you should:

An overdose may 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 contained in ClinOleic into the bloodstream (increased infusion rate) may cause serious side effects, such as respiratory disorders leading to reduced oxygen in the body (respiratory distress) and conditions causing high levels of acid in the body (metabolic acidosis). The effects of overdose are usually reversible when the infusion of ClinOleic is stopped (see section 4 Possible adverse effects).

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

If your doctor or nurse forgets to administer ClinOleic:

You must 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 adverse effects

Like all medicines, ClinOleic may cause adverse 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 adverse effects have been reported, occurring with varying frequency:

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

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

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

• Decrease in the number of white blood cells (leukopenia).
• Swelling of the abdomen (abdominal distension) or pain and discomfort in the stomach area.
• Yellowish discoloration of the skin and eyes caused by gallbladder problems (cholestasis).
• Increased levels of bilirubin.
• Increased liver enzymes or triglycerides in the blood.
• Dyspnea.

The following adverse effects have also been reported with unknown frequency:

• Decrease in platelets in the blood.
• Chills.
• Allergic reactions including red skin rash, itching of the skin (urticaria), pruritus.
• Diarrhea.

If you have a reduced ability to eliminate the lipids contained in ClinOleic, a "fat overload syndrome" may occur, which may have been caused by an overdose, but 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 may cause:

• Excess lipids in the blood (hyperlipidemia)
• Fever
• Fat infiltration of the liver
• Enlargement of the liver (hepatomegaly)
• Reduction in red blood cells (anemia)
• Decrease in white blood cells and blood platelets
• Blood coagulation disorders
• Coma.

All these symptoms are usually reversible when the infusion is stopped.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete (see section 2).

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

Store below 25°C.

Do not freeze.

Keep in the protective overpouch.

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 should be disposed of by healthcare personnel.

An oxygen absorber/oxygen indicator sachet is included inside the overpouch. Before opening the overpouch, check the colour of the oxygen indicator attached to the oxygen absorber. Compare it with the reference colour printed next to the OK symbol and described in the printed area of the indicator label. The sachet should be discarded after removing the overpouch.

Use immediately after opening.

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

Do not keep an opened bag for later use.

6. Contents of the pack and other information

Composition of ClinOleic

• Per 100 ml, the active substances 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:

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

Osmolarity: 270 mOsmol/l

pH: 6–8

Density: 0.986

• Other components: egg phospholipids, glycerol, sodium oleate, sodium hydroxide, and water for injections

• Phospholipids provide 47 milligrams or 1.5 mmol of phosphorus per 100 ml

Appearance of the product and contents of the pack

ClinOleic is a homogeneous, milky liquid.

It is supplied in plastic bags:

100 ml: packs of 24 or 10 units

250 ml: packs of 20 or 10 units

350 ml: packs of 12 or 10 units

500 ml: packs of 12 or 10 units

1000 ml: packs of 6 units

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

Only some pack sizes may be commercially available.

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states under the following names: ClinOleic 20%

Date of the most recent review of this leaflet: November 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only.

Method of administration:

When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete.

Special warnings and precautions for use:

Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with trace elements or vitamins, may have adverse effects on the clinical outcome in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, ClinOleic must be protected from ambient light until administration is complete.

Special precautions for disposal and other handling:

For single use only.

• Open

• Tear open the protective overwrap.

• Discard the oxygen absorber/indicator.

• Confirm the integrity of the bag.

• Use only if the bag is undamaged and the emulsion is a homogeneous milky-appearing liquid.

• Preparation for administration

• Hang the bag

• Remove the plastic protector from the administration port

• Firmly insert the spike of the infusion set into the administration port

• Additions

Do not make direct additions into the bag.

The lipids present are only one component of parenteral nutrition. Complete parenteral nutrition requires concomitant replacement with amino acids, carbohydrates, electrolytes, vitamins, and trace elements. Before administration to the patient, compatibility of components and stability of the mixture must be verified. This should be accompanied by gentle agitation during preparation and must only be performed under strict aseptic conditions.

• Administration

After opening the bag, the contents must be used immediately. An opened bag must never be stored for subsequent infusion. Do not reconnect partially used bags.

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

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

Unused medicine and all materials that have been in contact with it must be disposed of in accordance with local regulations.

When used in newborns and children under 2 years of age, the product must be protected from light exposure until administration is complete. Exposure of ClinOleic to ambient light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the product from light exposure.