Kabiven peripheral

Patient information leaflet: information for the user

Kabiven Peripheral, emulsion for infusion
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

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

1. What Kabiven Peripheral is and what it is used for

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

2. Important information before using Kabiven Peripheral

When not to use Kabiven Peripheral
Do not use this medicine:

• if the patient is allergic (hypersensitive) to Kabiven Peripheral, 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 experiencing acute shock (caused by loss of large amounts of blood or allergy);
• if the patient has blood clotting disorders (hemophagocytic syndrome) or if 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 levels of electrolytes (salts) in the blood;
• if the patient has metabolic acidosis (accumulation in 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 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 occurs in the body).

Kabiven Peripheral 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;
• disorders of fat metabolism;
• kidney diseases;
• any diseases of the pancreas;
• thyroid diseases – hypothyroidism;
• systemic inflammatory response (a condition in which an infection occurs in the body);
• disorders in elimination of electrolytes from the body;
• inadequate oxygen supply to cells;
• increased serum osmolality.

If fever, rash, chills, or difficulty breathing occur during infusion, notify medical personnel immediately. These symptoms may be due to an allergic reaction or administration of too high a 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 confirm that Kabiven Peripheral is working properly.
Kabiven Peripheral and 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 them;
• 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 have a child, she should consult a doctor or pharmacist before using this medicine.
There is no available data on the use of Kabiven Peripheral in pregnant or breastfeeding women. If parenteral (intravenous) nutrition is required in pregnant or breastfeeding women, the doctor will use Kabiven Peripheral only after carefully considering the benefits and risks.

3. How to use Kabiven Peripheral

Kabiven Peripheral is administered by infusion.
The dosage and the size of the container used are determined according to the patient's body weight
and their ability to metabolize fats and carbohydrates. Kabiven Peripheral should be given by slow infusion lasting from 12 to 24 hours. The dosage is determined individually for each patient by the physician.
Medical personnel may monitor the patient's health status during treatment.
Kabiven Peripheral must not be used in newborns and children under 2 years of age.
Administration of a higher than recommended dose of Kabiven Peripheral
It is unlikely that a patient would receive too high a dose of Kabiven Peripheral, as this medicine is administered by trained medical personnel. Symptoms of overdose may include nausea, vomiting, excessive sweating, and fluid retention in the body. Hyperglycaemia (too much sugar in the blood) and disturbances in electrolyte metabolism have also been observed. In the event of overdose, there is a risk of receiving an excessive amount of fat. This effect is known as the "fat overload syndrome". For detailed information, see section 4. Possible side effects. If the patient notices any of the above symptoms or suspects that they have received more than the recommended dose of Kabiven Peripheral, they should immediately inform their doctor or nurse. They may reduce the infusion rate or discontinue the infusion.
All these symptoms usually resolve or diminish after the infusion is stopped.
If there are any further doubts regarding the use of this medicine, consult a doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very rare (less than 1 in 10,000 patients): Kabiven Peripheral may cause
hypersensitivity (allergic reaction). Immediately inform the doctor if any of the following occur:

• raised, itchy rash on the skin;
• very high fever;
• difficulty breathing.

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

• increased body temperature;
• inflammation of the vein into which the medicine was administered.

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. The doctor will inform the patient if this adverse reaction occurs.

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

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

Fat overload syndrome
Fat overload syndrome occurs when the body has difficulty metabolizing fats due to receiving an excessive amount of Kabiven Peripheral. It may also occur due to a sudden change in the patient's health condition (e.g. kidney or liver problems). 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 those 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 at 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kabiven Peripheral

Keep this medicine out of the sight and reach of children.
The physician or pharmacist is responsible for ensuring appropriate storage, use, and disposal of Kabiven Peripheral.
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 is not suitable for further use.

6. Contents of the pack and other information

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

This corresponds to the following compositions:

The other ingredients (excipients) are: purified egg yolk phospholipids, glycerol,
sodium hydroxide (for pH adjustment), glacial acetic acid (for pH adjustment), and water for injections.
What Kabiven Peripheral 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 Peripheral pack consists of a three-compartment inner bag and an outer bag. Between the inner and outer bags there is an oxygen absorber, which must be removed before using the medicine. The inner bag is divided into three compartments sealed by welds, which break during preparation of the bag for use. The contents of all three compartments must be mixed before administration.
Pack sizes:
1440 ml, 1920 ml, 2400 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, 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 during catheter insertion and handling is recommended to prevent any infection.
Monitoring of serum glucose and electrolyte concentrations, osmolarity, fluid balance, acid-base equilibrium, and enzymatic liver function tests (alkaline phosphatase, AspAT, AlAT) is also recommended.
If any signs or symptoms of an anaphylactic reaction occur, the infusion must be stopped immediately.
Kabiven Peripheral must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
As with other hypertonic infusion solutions, thrombophlebitis may occur when administered via peripheral veins.

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

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 3.7 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, and 0.13 g lipids per kg body weight). The recommended duration of infusion is 12 to 24 hours.

Compatibility
Compatibility data are available for the drugs Dipeptiven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant, and Soluvit N, in specified amounts and in electrolytes at specified concentrations. When adding electrolytes, the amounts already present in the bag must be taken into account to meet the patient's clinical requirements. Available data confirm that the above-mentioned drugs can be added to the activated bag 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.

Warning: This table is intended to demonstrate compatibility only. It does not constitute dosage guidelines. Approved package leaflets must be consulted before prescribing the drugs listed above.
Information on compatibility with other additives and storage times for various mixtures is available on request.
All additives must be combined with the medicinal product under aseptic conditions.
Any unused residues of the medicinal product or waste material 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 bag contents
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 point of view, the product should be used immediately. Otherwise, the user is responsible for the storage period during use and the storage conditions prior to use. 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 addition of supplementary substances
After breaking the seals and mixing the contents of the bag chambers, additional components may be added via the additive port.
Physical and chemical stability of the mixed contents of the triple-chamber bag with supplementary 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. From a microbiological point of view, the product should be used immediately after addition of other components. Otherwise, the user is responsible for the storage period during use and the storage conditions prior to use. 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, colourless 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 portion of the medicinal product is not suitable for further use.
Any unused residues of the medicinal product or waste material must be disposed of in accordance with local regulations.

Kabiven Peripheral – 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 bag chambers
5. Blind port (used in manufacturing only)
6. Additive port
7. Infusion port
8. Oxygen absorber

1. Removal of the outer bag

• To remove the outer bag, lay it flat horizontally and, starting from the cut near the ports, tear along the upper edge (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 towards the ports, first with the right hand, then 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: mixing occurs 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 supplementary 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 supplementary substances (with known compatibility) into 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 of gauge 18 to 23 G and 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 if present.
• Hold the base of the infusion port.
• Insert the infusion device spike into the infusion port. To ensure proper fixation, 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.