Kabiven

Patient Information Leaflet

Kabiven, infusion emulsion
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What Kabiven is and what it is used for

Kabiven is a medicine containing: amino acids (components necessary for protein formation), fats, glucose, and electrolytes. It provides parenteral delivery of energy (from sugar and fats) and amino acids when oral nutrition is impossible, insufficient, or contraindicated.
Kabiven is indicated as a component of total parenteral nutrition, to be used in combination with salts, trace elements, and vitamins.

2. Important information before using Kabiven

When not to use Kabiven
Do not use this medicine:

• if the patient is allergic (hypersensitive) to Kabiven, to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to eggs, soy or peanuts;
• if the patient has elevated levels of fats (e.g. cholesterol) in the blood;
• if the patient has severe liver disease;
• if the patient is in acute shock (caused by loss of a large amount of blood or allergy);
• 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 (excessively high blood sugar levels) requiring administration of more than 6 units of insulin per hour;
• if the patient has elevated electrolyte (salt) levels in the blood;
• if the patient has metabolic acidosis (accumulation in the blood and tissues of excessive amounts of acidic substances);
• if the patient has excess fluid in 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 dehydrated and has low salt levels;
• if the patient has severe systemic inflammatory response (a condition in which a severe infection is present in the body).

Kabiven must not be used in newborns and children under 2 years of age.
Warnings and precautions
Inform the doctor if the patient has:

• impaired liver function;
• untreated diabetes;
• fat metabolism disorders;
• kidney diseases;
• any pancreatic diseases;
• thyroid diseases – hypothyroidism;
• systemic inflammatory response (a condition in which an infection is present in the body);
• disorders in elimination of electrolytes from the body;
• inadequate oxygen delivery to cells;
• increased serum osmolality.

If fever, rash, chills or difficulty breathing occur during infusion, medical personnel must be
notified immediately. These symptoms may be due to an allergic reaction or administration of an excessive dose of the medicine (see section 4).
This medicine may affect the results of certain laboratory tests. Inform the doctor that this medicine
is being used before any test is performed.
The doctor may recommend regular blood tests to monitor the proper effect of Kabiven.
Kabiven with other medicines
Tell the doctor or nurse about all medicines the patient is currently taking, has recently taken, or
plans to take.
Inform the doctor if the patient is taking:

• heparin – a medicine that prevents blood clots and helps dissolve existing clots;
• warfarin, because vitamin K present in soybean oil may affect blood clotting;
• insulin – a medicine used in the treatment of diabetes.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
There are no data available on the use of Kabiven in pregnant or breastfeeding women. If parenteral (intravenous) nutrition is required during pregnancy or breastfeeding, the doctor will use Kabiven only after careful consideration of the benefits and risks.

3. How to use Kabiven

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

Overdose of Kabiven
It is unlikely that a patient would receive too high a dose of Kabiven, as this medicine is administered by trained medical personnel. Symptoms of overdose may include nausea, vomiting, excessive sweating, and fluid retention. Hyperglycaemia (excess blood sugar) and electrolyte imbalances have also been observed. In case of overdose, there is a risk of receiving too much fat. This effect is known as the "fat overload syndrome". For detailed information, see section 4. Possible side effects. If the patient experiences any of the above symptoms or suspects that they have received more than the recommended dose of Kabiven, they should immediately inform their doctor or nurse. The medical staff may reduce the infusion rate or discontinue the infusion.
All these symptoms usually resolve or diminish after stopping the infusion.
If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rarely (less than 1 in 10,000 patients), Kabiven may cause an allergic reaction
(hypersensitivity). You should immediately inform your doctor if any of the following occur:

• lumpy, itchy rash on the body;
• very high temperature;
• difficulty breathing.

Common adverse reactions (less than 1 in 10 patients, but more than 1 in 100 patients):

• increased body temperature.

Uncommon adverse reactions (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. Your doctor will inform you if this adverse reaction occurs.

Other adverse reactions occur very rarely (less than 1 in 10,000 patients):

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

Fat overload syndrome
Fat overload syndrome occurs when the body has difficulty metabolizing fats due to receiving an excessive amount of Kabiven. It may also occur due to a sudden change in the patient's health condition (e.g. kidney problems or infection). Possible symptoms include fever, increased fat levels in the blood, cells and tissues, disturbances in the function of multiple organs, and coma. All these symptoms usually resolve after stopping the infusion.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of using the medicine can be collected.

5. How to store Kabiven

Keep this medicine out of the sight and reach of children.
Your doctor or pharmacist is responsible for ensuring appropriate 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 container.
Do not use if the packaging is damaged.
For single use only. Any unused portion of the medicine must not be used later.

6. Contents of the package and other information

What Kabiven contains
Kabiven is available in three-chamber bags.
Three-chamber bags are manufactured in four different sizes.
Each three-chamber bag contains the following components in different volumes:

This corresponds to the following compositions:

Other ingredients (excipients): purified egg yolk phospholipids, glycerol,
sodium hydroxide (for pH adjustment), glacial acetic acid (for pH adjustment), and water for injections.
What Kabiven looks like and contents of the pack
Solutions of glucose and amino acids with electrolytes are clear, colourless to slightly yellow,
and the fat emulsion is white and homogeneous. The Kabiven package consists of a triple-chamber
inner bag and an outer bag. Between the inner and outer bags there is an oxygen absorber, which must be removed before using the medicinal product. The inner bag is divided into three chambers sealed by welds, which rupture during preparation of the bag for use. The contents of all three chambers must be mixed before administration.
Pack sizes:
1026 ml, 1540 ml, 2053 ml, 2566 ml.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Fresenius Kabi AB
S-751 74 Uppsala
Sweden
For further information, contact the marketing authorisation holder's representative:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Special warnings and precautions for use
To avoid risks associated with too rapid infusion rate, it is recommended that the infusion be administered continuously and appropriately controlled, preferably using a volumetric pump.
Since the use of a central vein for infusion is associated with an increased risk of infection, strict adherence to aseptic procedures is recommended during catheter insertion and handling to prevent any infection.
Monitoring of serum glucose and electrolyte concentrations, osmolality, fluid balance, acid-base balance, and enzymatic liver function tests (alkaline phosphatase, AspAT, AlAT) is also recommended.
If any signs or symptoms of an anaphylactic reaction occur (such as fever, chills, rash, or dyspnea), the infusion must be stopped immediately.
Kabiven should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.

Method of administration
Intravenous administration, infusion into a central vein.
To ensure complete parenteral nutrition, trace elements, vitamins, and electrolytes should be supplemented as needed, taking into account the electrolytes already present in Kabiven.

Infusion rate
The maximum glucose infusion rate is 0.25 g/kg body weight/hour.
The amino acid dose should not exceed 0.1 g/kg body weight/hour.
The lipid dose 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 lipids per kg body weight). The recommended duration of infusion is 12 to 24 hours.

Compatibility
Compatibility data are available for Dipeptiven, Omegaven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant and Soluvit N, in specified amounts and in electrolytes of defined concentration. When adding electrolytes, their existing quantities in the bag must be taken into account to meet the patient's clinical requirements. Available data confirm that the addition of the above-mentioned medicinal products to the activated bag is compatible according to the table below:
Compatibility range: stable for 8 days, i.e. 6 days stored at 2–8 °C, followed by 48 hours at 20–25 °C.

Compatibility range with Omegaven: stable for 48 hours at 20-25 °C.

Warning: These tables are intended to demonstrate compatibility only. They do not constitute dosing guidelines. Approved package leaflets must be consulted before prescribing the aforementioned medicinal products.
Information on compatibility with other additives and storage times for various mixtures is available upon request.
All additives must be combined with the medicinal product under aseptic conditions.
Any unused residues or waste material of the medicinal product must 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 bag chambers
Physical and chemical stability of the mixed contents of the triple-chamber bag has been demonstrated for 48 hours at 20–25°C, including infusion duration. From a microbiological standpoint, the medicinal product should be used immediately. Otherwise, the user is responsible for the storage period during use and for storage conditions prior to administration. This period should not generally exceed 24 hours at 2–8°C unless mixing was carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additional substances
After breaking the seals and mixing the contents of the bag chambers, other components may be added via 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: 6 days at 2–8°C followed by 48 hours at 20–25°C, including infusion duration, or with the addition of Omegaven for 48 hours at 20–25°C, including infusion duration. From a microbiological standpoint, the medicinal product should be used immediately after addition of other components. Otherwise, the user is responsible for the storage period during use and for storage conditions prior to administration. This period should not generally exceed 24 hours at 2–8°C unless mixing was carried out under controlled and validated aseptic conditions.

Disposal of unused medicinal product
Do not use if the packaging is damaged.
Use only if 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 must be mixed before use.
Immediately after breaking the seals, invert the bag several times to obtain a homogeneous mixture prior to infusion.
For single use only. Any unused residue of the medicinal product is not suitable for further use.
Any unused residues or waste material of the medicinal product must be disposed of in accordance with local regulations.

Kabiven – Instructions for preparing the Biofine-type bag for use

1. Cut in the outer bag
2. Bag handle
3. Hanging hole
4. Seals separating individual chambers of the bag
5. Blind port (used only during manufacturing)
6. Additive port
7. Infusion port
8. Oxygen absorber

1. Removal of the outer bag

• To remove the outer bag, lay it horizontally and begin tearing along the upper edge from the cut near the ports (A).
• Then tear the outer bag along the long edge, remove it, and discard together with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, firmly roll the bag toward the ports with the right hand, then continue applying steady pressure with the left hand until the vertical seals rupture. The seals open under fluid pressure. The seals may also be opened before removing the outer bag. Note: The liquid mixes easily even if the horizontal seal remains intact.

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

3. Final preparation steps

• Place the bag again on a flat, level surface. Just before adding additional substances, remove the single-use cap marked with an arrow, which protects 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 additional substances (with known compatibility) through the center of the injection site (B).
• After each addition, thoroughly mix the bag contents by inverting the bag three times. Use syringes with needles sized 18 to 23 G and with a maximum length of 40 mm.

• Just before connecting the infusion set, remove the single-use cap protecting 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 infusion set spike into the infusion port. To ensure secure attachment, insert the full length of the spike. Note: The inner surface of the infusion port is sterile.

4. Hanging the bag

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