Kabiven

Leaflet accompanying the packaging: information for the user

Kabiven, infusion emulsion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Kabiven and what is it used for
• 2. Important information before using Kabiven
• 3. How to use Kabiven
• 4. Possible side effects
• 5. How to store Kabiven
• 6. Contents of the packaging and other information

1. What is Kabiven and what is it used for

Kabiven is a medicine that contains: amino acids (components necessary for protein production), fats, glucose, and electrolytes. It provides intravenous delivery of energy (from sugar and fat) and amino acids when oral nutrition is impossible, insufficient, or contraindicated. Kabiven is indicated for use as a component of total parenteral nutrition, along with salts, trace elements, and vitamins.

2. Important information before using Kabiven

When not to use Kabiven

Do not use the medicine:

• if the patient has an allergy(hypersensitivity) to Kabiven, to the active substances or to any of the other components of this medicine (listed in section 6);
• if the patient has an allergy (hypersensitivity) to eggs, soy or peanuts;
• if the patient has too high a level of fat(e.g. cholesterol) in the blood;
• if the patient has severe liver disease;
• if the patient is experiencing septic shock(caused by blood loss or an allergic reaction);
• if the patient has coagulation disorders(hemophagocytic syndrome) or if the blood does not clot properly;
• if the patient has disorders of protein or amino acid metabolism;
• if the patient has severe kidney disease;
• if the patient has hyperglycemia (too much sugar in the blood) requiring the administration of more than 6 units of insulin per hour;
• if the patient has high levels of electrolytes(salts) in the blood;
• if the patient has metabolic acidosis(accumulation of excessive amounts of acidic substances in the blood and tissues);
• if the patient has too much fluidin the body (overhydration);
• if the patient has fluid in the lungs(acute pulmonary edema);
• if the patient is in a coma;
• if the patient has heart problems;
• if the patient is dehydratedand has low salt levels;
• if the patient is experiencing a severe systemic inflammatory response(a condition in which there is a severe infection in the body).

Kabiven should not be used in newborns and children under 2 years of age.

Warnings and precautions

Inform your doctor if you have:

• liver function disorders;
• untreated diabetes;
• fat metabolism disorders;
• kidney disease;
• any pancreatic diseases;
• thyroid diseases - hypothyroidism;
• systemic inflammatory response(a condition in which there is an infection in the body);
• electrolyte excretion disorders;
• insufficient oxygen supplyto cells;
• increased serum osmolality.

If fever, rash, chills, or difficulty breathing occur during infusion, immediately notify medical personnel. These symptoms may be caused by an allergic reaction or too high a dose of the medicine (see section 4). This medicine affects the results of some tests. Inform your doctor about the use of this medicine before performing the test. The doctor may recommend regular blood tests to confirm the proper functioning of Kabiven.

Kabiven and other medicines

Tell your doctor or nurse about all medicines you are taking, have recently taken, or plan to take. Inform your doctor if you are taking:

• heparin - a medicine that prevents blood clots and helps dissolve them;
• warfarin, as vitamin K in soybean oil may affect blood clotting;
• insulin - a medicine used to treat diabetes.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. There is no data on the use of Kabiven in pregnant or breastfeeding women. If parenteral nutrition (intravenous) is required in pregnant or breastfeeding women, the doctor will use Kabiven only after careful consideration of the benefits and risks.

3. How to use Kabiven

Kabiven is administered by infusion exclusively into a central vein. The dosage and size of the packaging are determined based on the patient's body weight and their ability to metabolize fats and sugars. Kabiven is administered in a slow infusion lasting from 12 to 24 hours. The dosage is determined individually by the doctor for each patient. Medical personnel may monitor the patient's health during treatment. Kabiven should not be used in newborns and children under 2 years of age.

Using a higher dose of Kabiven than recommended

It is unlikely that a patient will receive too high a dose of Kabiven, as the medicine is administered by medical personnel. Symptoms of overdose are nausea, vomiting, excessive sweating, and fluid retention in the body. Hyperglycemia (too much sugar in the blood) and electrolyte balance disorders have also been observed. In the event of an overdose, there is a risk of excessive fat intake. This symptom is called "fat overload syndrome". For detailed information, see section 4. Possible side effects. If the patient notices the above symptoms or believes they have received a higher dose of Kabiven than recommended, they should immediately inform their doctor or nurse. They may reduce the infusion rate or stop it. All these symptoms usually disappear or decrease after the infusion is stopped. In case of any further doubts about the use of this medicine, consult a doctor, nurse, or pharmacist.

4. Possible side effects

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

Very rare (less than 1 in 10,000 patients) Kabiven may cause an allergy (hypersensitivity). Immediately inform your doctor if you experience:

• a lumpy and itchy rash on the body;
• very high fever;
• difficulty breathing.

Frequent side effects (less than 1 in 10 patients, but more than 1 in 100 patients):

• increased body temperature.

Uncommon side effects (less than 1 in 100 patients, but more than 1 in 1,000 patients):

• chills;
• fatigue,
• abdominal pain;
• headache;
• nausea;
• vomiting;
• increased liver enzyme activity. The doctor will inform the patient about the occurrence of this side effect.

Other side effects occur very rarely (less than 1 in 10,000 patients):

• increased or decreased blood pressure;
• rapid breathing;
• prolonged, painful erection in men;
• blood test abnormalities.

Fat overload syndrome

Fat overload syndrome occurs when the body has a problem with fat metabolism due to excessive intake of Kabiven. It can also occur due to a sudden change in the patient's health (e.g. kidney problems or infection). Possible symptoms include fever, increased fat levels in the blood, cells, and tissues, disorders in the functioning of many organs, and coma. All these symptoms usually disappear after the infusion is stopped.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Kabiven

The medicine should be stored out of sight and reach of children.

The doctor or pharmacist is responsible for ensuring proper storage, use, and disposal of Kabiven. Do not store above 25°C. Store in the outer bag. Do not freeze. Do not use this medicine after the expiry date stated on the packaging. Do not use if the packaging is damaged. For single use only. Unused remnants of the medicine are not suitable for further use.

6. Contents of the packaging and other information

What Kabiven contains

Kabiven is available in triple-chamber bags. The bags containing 3 chambers are manufactured in four sizes. Each triple-chamber bag contains the following different volumes of components: This corresponds to the following compositions:

Other ingredients (excipients) are:purified egg phospholipids, glycerol, sodium hydroxide (for pH adjustment), glacial acetic acid (for pH adjustment), and water for injections.

What Kabiven looks like and what the packaging contains

The glucose and amino acid solutions with electrolytes are clear, colorless to slightly yellow, and the fat emulsion is white and homogeneous. The Kabiven packaging consists of a triple-chamber inner bag and an outer bag. Between the inner bag and the outer bag, there is an oxygen absorber that should be removed before using the medicine. The inner bag is divided into three chambers by welds that rupture during preparation of the bag for use. The contents of all three chambers should be mixed before use.

Package sizes:

1026 ml, 1540 ml, 2053 ml, 2566 ml. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Fresenius Kabi AB, S-751 74 Uppsala, Sweden. For more information, contact the representative of the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89. Date of last revision of the leaflet:16.11.2023.

Information intended for healthcare professionals only:

Special warnings and precautions for use

In order to avoid the risks associated with too high an infusion rate, it is recommended to perform it continuously and in a controlled manner, if possible using a volumetric pump. Since the use of a central vein for infusion is associated with an increased risk of infection, when inserting and handling the catheter, it is recommended to strictly follow aseptic procedures to avoid any infection. It is also recommended to monitor glucose and electrolyte levels in serum, osmolality, as well as fluid balance, acid-base balance, and perform liver enzyme tests (alkaline phosphatase, AspAT, AlAT). In case of any signs or symptoms of an anaphylactic reaction (such as fever, chills, rash, or shortness of breath), the infusion should be stopped immediately. Kabiven should not be administered simultaneously with blood in the same infusion set, due to the risk of pseudoagglutination.

Method of administration

Intravenous administration, infusion into a central vein. In order to ensure complete parenteral nutrition, additional substances should be used as needed, such as trace elements, vitamins, and electrolytes (taking into account the electrolytes contained in Kabiven).

Infusion rate

The maximum infusion rate of glucose is 0.25 g/kg body weight/hour. The dose of amino acids should not exceed 0.1 g/kg body weight/hour. The dose of fat should not exceed 0.15 g/kg body weight/hour. The infusion rate should not exceed 2.6 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, and 0.1 g fat per kg body weight). The recommended infusion time is from 12 to 24 hours.

Compatibility

Compatibility data are available for the medicines Dipeptiven, Omegaven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant, and Soluvit N in specified quantities and in electrolytes of specified concentration. When adding electrolytes, their quantities already present in the bag should be taken into account to meet the patient's clinical needs. Available data confirm the possibility of adding the above-mentioned medicines to the activated bag in accordance with the table below: Compatibility range: stable for 8 days, i.e. 6 days stored at a temperature of 2-8°C, and then 48 hours at a temperature of 20-25°C.

The compatibility range with Omegaven is stable for 48 hours at a temperature of 20-25°C.

Note: These tables are intended to demonstrate compatibility. They do not serve as dosage guidelines. Before prescribing the above-mentioned medicines, read the approved information leaflets. Information on compatibility with other additives and storage times of different mixtures is available upon request. All additives should be mixed with the medicine under aseptic conditions. Any unused remnants of the medicine or its waste should be disposed of in accordance with local regulations.

Shelf life and storage conditions

Do not store above 25°C. Store in the outer bag. Do not freeze. Shelf life after mixing the contents of the bagPhysical and chemical stability of the mixed contents of the triple-chamber bag has been demonstrated for 48 hours at a temperature of 20-25°C, including the infusion time. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not normally exceed 24 hours at a temperature of 2-8°C, unless mixing took place in controlled and validated aseptic conditions. Shelf life after mixing with additional substancesAfter breaking the seals and mixing the contents of the bag, other components can be added through the additive port. Physical and chemical stability of the mixed contents of the triple-chamber bag with additional substances has been demonstrated for up to 8 days, i.e. 6 days at a temperature of 2-8°C, and then 48 hours at a temperature of 20-25°C, including the infusion time, or with the addition of Omegaven for 48 hours at a temperature of 20-25°C, including the infusion time. From a microbiological point of view, the medicine should be used immediately after adding other components. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not normally exceed 24 hours at a temperature of 2-8°C, unless mixing took place in controlled and validated aseptic conditions.

Disposal of leftovers

Do not use if the packaging is damaged. Use only if the amino acid solutions with electrolytes and glucose are clear, colorless to slightly yellow, and the fat emulsion is white and homogeneous. The contents of all three chambers should be mixed before use. After removing the protective covers, immediately roll the bag several times from the handle side towards the ports to obtain a homogeneous mixture before infusion. For single use only. Unused remnants of the medicine are not suitable for further use. Any unused remnants of the medicine or its waste should be disposed of in accordance with local regulations.

Kabiven - Instructions for preparing the Biofine bag for use

• 1. Notch in the outer bag
• 2. Bag handle
• 3. Hole for hanging the bag
• 4. Welds separating the individual chambers of the bag
• 5. Blind port (used only in production)
• 6. Additive port
• 7. Infusion port
• 8. Oxygen absorber

1. Removing the outer bag

• To remove the outer bag, place it horizontally and, starting from the notch located near the ports, tear it along the top edge (A).
• Then tear the outer bag along the long edge, remove it, and discard it along with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, firmly roll the bag towards the ports, first with the right hand, and then applying constant pressure with the left hand, until the vertical welds rupture. They open under the pressure of the liquid. The welds can also be opened before removing the outer bag. Note:the liquid mixes easily, even though the horizontal weld remains intact.

• Mix the contents of the three chambers by turning the bag three times, which should ensure thorough mixing of the components.

3. Final preparation steps

• Place the bag on a flat, even surface again. Just before adding additional substances, remove the labeled plug from the white additive port (A). Note:the membrane of the additive port is sterile.
• Hold the base of the additive port. Insert the needle and inject the additional substances (with known compatibility) through the center of the injection site (B).
• Mix the contents of the bag thoroughly after adding each component by turning the bag three times after each addition. Use syringes with needles with a diameter of 18 to 23 G and a maximum length of 40 mm.

• Just before connecting the infusion set, remove the plug from the blue infusion port (A). Note:the membrane of the infusion port is sterile.
• Use infusion sets without an air vent or close the air vent.
• Hold the base of the infusion port.
• Insert the needle of the infusion device into the infusion port. To ensure good fixation of the needle, insert its entire length. Note:the inner surface of the infusion port is sterile.

4. Hanging the bag

• Hang the bag using the hole located below the handle.