Clinoleic 20%

Package Leaflet: Information for the User

ClinOleic 20%, Infusion Emulsion

Purified olive oil and purified soybean oil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is ClinOleic and what is it used for
• 2. Important information before using ClinOleic
• 3. How to use ClinOleic
• 4. Possible side effects
• 5. How to store ClinOleic
• 6. Package contents and other information

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

1. What is ClinOleic and what is it used for

ClinOleic is a fat emulsion for infusion, containing a mixture of olive oil (80%) and soybean oil (20%).
ClinOleic is used as a source of energy and essential fatty acids (fats or lipids) that cannot be synthesized in the body. ClinOleic is administered directly into the patient's blood, bypassing the digestive system. This method of nutrition (parenteral nutrition) is used when, for medical reasons, eating and drinking cannot be done through the digestive system.

2. Important information before using ClinOleic

When not to use ClinOleic

• If the patient is allergic (hypersensitive) to egg protein, soy protein, or peanut protein, or to any of the other ingredients of this medicine (listed in section 6)
• If the patient has a high level of fats in the blood (severe hyperlipidemia)
• If the patient has uncontrolled metabolic disorders, including lactic acidosis and uncontrolled diabetes

Warnings and precautions

Close clinical monitoring is recommended at the start of each infusion.
If unusual signs or symptoms of an allergic reaction occur, the infusion will be stopped immediately.
These symptoms include: sweating, fever, chills, headache, skin rash, or difficulty breathing (dyspnea). The medicine contains soybean oil and egg phospholipids for injection. Soy and egg proteins can cause hypersensitivity reactions. Cross-reactions between soy and peanut proteins have been observed.
The doctor will check and monitor the patient's triglyceride levels and blood sugar levels.
Certain medicines and diseases can increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis after inserting a catheter into the patient's vein. The doctor will carefully monitor the patient for signs of infection. Patients requiring parenteral nutrition (administration of nutrients through a vein) may be more susceptible to infection due to their clinical condition. Using aseptic technique (a procedure that ensures the absence of microorganisms) when inserting and maintaining the catheter and when preparing the medicine for infusion can reduce the risk of infection.
The doctor will determine the dose and rate of administration, taking into account the use of a final filter.
The doctor should be informed:

• about severe conditions affecting carbohydrate, fat, protein, and salt metabolism in the body (metabolic disorders)
• about severe generalized blood infection (septicemia)
• about severe liver disease
• about blood coagulation disorders
• about heart attack (myocardial infarction)
• about heart failure
• about kidney failure
• about reduced red blood cell count (anemia)
• about fluid in the lungs

The doctor should be informed if the patient experiences swelling, sensitivity, and redness at the injection site, as this may be a sign of inflammation (thrombophlebitis).
In newborns (infants) and small children (children under 2 years), rapid administration of fats into the bloodstream has been reported to cause severe side effects, such as respiratory disorders leading to decreased oxygen levels in the body (respiratory failure) and conditions leading to increased acid levels in the body (metabolic acidosis) (see also section 3, Administration of a higher dose of ClinOleic than recommended).
From the start of the infusion, the doctor will monitor the patient's condition, especially if they have liver, kidney, adrenal, heart, or circulatory problems.
During the administration of the medicine, the doctor will perform clinical tests and laboratory tests to check the effectiveness and safety of the medicine.

Children and adolescents

ClinOleic can be used in small children if the administration of the medicine is closely monitored. ClinOleic has been used for up to 7 days in newborns and up to 2 months in children.
When used in newborns and children under 2 years, the solution (in the bag and administration set) should be protected from light until the end of the administration (see section 2). Exposure of ClinOleic to light, especially after the addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by protecting the medicine from light.

ClinOleic and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The olive oil and soybean oil in ClinOleic contain vitamin K. This usually does not affect the action of anticoagulant medicines, such as coumarin. However, if the patient is taking anticoagulant medicines, they should inform their doctor.

Pregnancy and breastfeeding

The safety of using ClinOleic in pregnant and breastfeeding women has not been established.
Therefore, ClinOleic should not be used in pregnant and breastfeeding women unless advised by a doctor.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

3. How to use ClinOleic

ClinOleic contains 200 mg of fat per 1 ml.

Dosage

Administration in adults

The doctor will decide on the appropriate dosage based on the patient's clinical condition.
The dosage is from 1 to a maximum of 2 grams of fat/kg body weight per day.

Administration in children

It is not recommended to administer more than 3 grams of fat/kg body weight per day.

Administration in premature infants and children with low birth weight

ClinOleic can be administered to premature infants born at 28 weeks of gestation or later.
It is not recommended to administer more than 2 grams of fat/kg body weight per day.

Method and route of administration

ClinOleic will be administered through a plastic tube connected to a needle inserted into the patient's vein (intravenous infusion).
When used in newborns and children under 2 years, the solution (in the bag and administration set) should be protected from light until the end of the administration (see section 2).

Administration of a higher dose of ClinOleic than recommended

Overdose can cause decreased ability of the body to eliminate the fats contained in ClinOleic (fat overload syndrome). In newborns (infants) and small children (children under 2 years), overdose and/or rapid administration of fats into the bloodstream can lead to severe side effects, such as respiratory disorders leading to decreased oxygen levels in the body (respiratory failure) and conditions leading to increased acid levels in the body (metabolic acidosis) (see also section 4, Possible side effects). The effects of overdose are usually reversible when the infusion of ClinOleic is stopped (see also section 4, Possible side effects).

Missing a dose of ClinOleic

The patient should not receive a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ClinOleic can cause side effects, although not everybody gets them.
If unusual symptoms occur at the start of the infusion, it should be stopped immediately. These symptoms include: excessive sweating, chills, headaches, and difficulty breathing (dyspnea).
Other side effects have also been observed, occurring with greater or lesser frequency:

• increased blood sugar levels (hyperglycemia)
• increased blood lipid levels (hyperlipidemia)
• decreased protein levels (hypoproteinemia)
• feeling of nausea (nausea), vomiting
• abdominal swelling (abdominal distension)
• decreased blood pressure
• jaundice (yellowing of the skin and eyes) due to bile duct disorders or increased bilirubin levels
• increased triglyceride levels in the blood

The following side effects occur uncommonly and affect 1 to 10 in 1000 patients:

• decreased white blood cell count (leukopenia)
• abdominal pain and discomfort in the stomach area
• difficulty breathing (dyspnea)
• chills
• flushing
• liver inflammation with liver cell destruction
• increased pancreatic enzyme activity

The following side effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):

• decreased platelet count
• allergic reactions, including red itchy rash (hives), itching
• diarrhea

Side effects reported with similar medicinal products:
liver failure, end-stage liver disease, liver fibrosis, liver steatosis, cholecystitis, cholelithiasis.
Decreased ability to eliminate the fats contained in ClinOleic can cause "fat overload syndrome". This can result from overdose, but can also occur at the start of the infusion, even with proper administration of the product. This can lead to sudden worsening of the patient's clinical condition. Fat overload syndrome can lead to:

• excess fat in the blood (hyperlipidemia)
• fever
• fatty liver infiltration
• liver enlargement (hepatomegaly)
• decreased red blood cell count (anemia)
• decreased white blood cell and platelet count
• blood coagulation disorders
• coma. These symptoms usually resolve after the infusion is stopped.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, you should tell your doctor or nurse.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products)
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store ClinOleic

Keep the medicine out of the sight and reach of children.
When used in newborns and children under 2 years, the solution (in the bag and administration set) should be protected from light until the end of the administration (see section 2).
Do not use ClinOleic after the expiry date stated on the label after "Expiry date". The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Do not freeze.
Protect from light.
Store in the protective packaging.
Do not use if the bag is damaged or if the emulsion is not homogeneous with a milky appearance.
Partially used packages should be discarded. Do not reconnect bags with remaining emulsion; they should be discarded by medical personnel.
A oxygen absorber/sensor sachet is included in the protective packaging.
Before opening the protective packaging, check the color of the oxygen sensor on the sachet. It should match the control color printed next to the OK symbol on the sensor and marked on the label of the sensor. The sachet should be discarded after removing the protective packaging.
Use immediately after opening.
Do not use the product if the sensor color does not match the control color.
Do not store the opened bag for the next infusion.

6. Package contents and other information

What ClinOleic contains

• 100 ml of the emulsion for infusion contains the following active substances: purified olive oil (80%) and purified soybean oil (20%) .................. 20.00 g, which corresponds to the content of essential fatty acids .......................... 4.00 g
• Properties: Energy value ……………………………………… 2000 kcal/l (8.36 MJ/l) Osmolality …………………………………………………………… 270 mOsm/l pH ………………………………………………………………………………... 6-8 Density …………………………………………………………………….…... 0.986
• Other ingredients are: egg phospholipids for injection, glycerol, sodium oleate, sodium hydroxide, water for injection.
• The phospholipids provide 47 milligrams (1.5 mmol) of phosphorus per 100 ml.

What ClinOleic looks like and what the package contains

ClinOleic is a homogeneous milky liquid.
ClinOleic is supplied in a plastic bag.
The bag has a capacity of: 100 ml, 250 ml, 350 ml, 500 ml, 1000 ml.
Not all packages may be marketed.

Marketing authorization holder:

Baxter Polska Sp. z o. o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturer:

Baxter SA
Boulevard Rene Branquart 80
7860 Lessines, Belgium

Date of last revision of the package leaflet: November 2023

Baxter and Clinoleic are trademarks of Baxter International Inc.