Leaflet: information for the patient

Kabiven emulsion for infusion

Read this leaflet carefully before you start using this medicine, because it contains important information for you:

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

1. What Kabiven is and what it is used for

2. What you need to know before you start using Kabiven

3. How to use Kabiven

4. Possible side effects

5. Storage of Kabiven

6. Contents of the pack and additional information

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Kabiven is presented in a three-chamber bag with an overbag. Kabiven contains the following medications: amino acids (components used to build proteins), lipids, glucose, and electrolytes. It provides energy (in the form of sugar and lipids) and amino acids to your bloodstream when you cannot eat normally.

It is used as part of a balanced intravenous diet, together with salts, trace elements, and vitamins to fully meet your nutritional needs.

Do not use Kabiven:

• if you are allergic to any of the active substances or to any of the components of this medicine (listed in section 6).
• if you are allergic to products that containegg, soy, or peanut
• if you haveexcessive fatty substances(such as cholesterol) in your blood
• if you have severely impairedliver function
• if you suffer fromacute shock(leading to significant blood loss or allergic reaction)
• if you havebleeding disordersassociated with a known condition (such as hemophagocytic syndrome) or if yourblood does not clot properly
• if your body has problems usingproteins or amino acids
• if you have severe problems with yourkidneys
• if you havehyperglycemia(too much sugar in your blood) that requires the administration of more than 6 units of insulin per hour
• if you haveelevated levels of electrolytes(salts) in your blood
• if you havemetabolic acidosis(your body fluids and tissues have too high levels of acid)
• if you haveexcessive fluidin your body (hyperhydration)
• if you havefluid in your lungs(acute pulmonary edema)
• if you are in a coma
• if you have heart problems
• if you aredehydratedwith low salt levels
• if you havesevere sepsis(a condition in which your body suffers from a severe infection)

Warnings and precautions

Inform your doctor before Kabiven is administered to you if you have:

• impairedliver function
• uncontrolled diabetes
• a condition in which your body has problems usinglipidsproperly
• kidney dysfunction
• any problem with yourpancreas
• thyroid problems – hypothyroidism
• sepsis(a condition in which your body suffers from an infection)
• your body has problems eliminatingelectrolytes
• a condition in whichthere is not enough oxygenin your body cells
• increased serum osmolality

If during the infusion you experience fever, skin rash, chills, or difficulty breathing, inform your healthcare professional immediately. These symptoms may be caused by an allergic reaction or because you have received too much medication (see section 4).

This medicine may affect the results ofother teststhat you undergo. It is essential to inform the doctor performing the tests that you are receiving Kabiven.

Your doctor may perform regular blood tests to ensure that your body is receiving Kabiven correctly.

Children

Kabiven will not be administered to newborns or children under two years of age.

Use of Kabiven with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medicines.

Inform your doctor if you are taking

• a medication known as heparin, which is used to prevent blood clotting and to help disperse clots
• warfarin, also known as vitamin K1, which is found in soy oil and may affect blood clotting
• insulin for the treatment of diabetes

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. The safety of using Kabiven during pregnancy and breastfeeding has not been established. If you need parenteral nutrition during pregnancy or breastfeeding, your doctor will administer Kabiven only after thorough consideration.

Driving and operating machinery

No adverse effects on the ability to drive and use machinery are expected from Kabiven.

You will receive your medication through a central vein infusion only. The dose of Kabiven and the size of the bag used depends on your body weight in kilograms and your body's ability to use fats and sugar. Kabiven will be infused slowly over a period of 12-24 hours. Your doctor will decide on the correct dose you or your child should receive. You may be monitored during treatment.

Children

Kabiven is not suitable for use in newborns or children under two years of age.

If you take more Kabiven than you should

It is very unlikely that you will receive more infusion than you should, as your doctor or nurse will monitor you during treatment. The effects of an overdose may include nausea, vomiting, chills, and fluid retention. Hyperglycemia (too much sugar in your blood) and electrolyte imbalances have also been reported. In the case of an overdose, there is a risk of receiving too many fats. This is called "lipid overload syndrome". For more information, see section 4 "Possible side effects". If you experience any of the symptoms described above or think you have received too much Kabiven, inform your doctor or nurse immediately. The infusion may be stopped immediately or continued at a reduced dose.

If you have any questions related to the use of this product, ask your doctor or nurse.

Like all medications,Kabivenmay cause adverse effects, although not everyone will experience them.

Kabiven may cause an allergic reaction (very rare, may affect up to 1 in 10,000 patients). Inform your doctor immediately if:

• a skin rash with itching and redness appears in your body
• you have a very high temperature
• you have difficulty breathing

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 patients)

• mild increase in body temperature

Less frequent adverse effects (may affect up to 1 in 100 patients)

• chills
• fatigue
• stomach pain
• headache
• sense of illness
• increase in liver enzymes. Your doctor will indicate if this occurs

Very rare (may affect up to 1 in 10,000 patients)

• high or low blood pressure
• difficulty breathing
• prolonged and painful erections in men
• problems with your blood

Lipid Overload Syndrome

This could occur if your body had problems using lipids, and you had received too much Kabiven. It can also occur due to a sudden change in your situation (such as kidney problems or infection). Possible symptoms are fever, high levels of lipids in your blood, cells, and tissues, alterations in various organs, and coma. All these symptoms generally disappear if the infusion is stopped.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children

Your doctor or the hospital pharmacist is responsible for the correct conservation, use, and disposal of the Kabiven infusion. Do not store above 25°C. Do not freeze and always keep the container in the outer container.

The emulsion should not be used after the expiration date indicated on the label. Any remaining emulsion should be removed through authorized hospital procedures.

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Kabiven Composition

Kabiven is available in a three-chamber bag system. Each bag contains the following different volumes depending on the four packaging sizes:

- The active substances are

- The other ingredients are

Purified Egg Phospholipids

Glycerol

Sodium Hydroxide

Glacial Acetic Acid

Water for Injection.

Appearance of the Product and Contents of the Container

The glucose and amino acid solutions are transparent and colorless or slightly yellowish, and the lipid emulsion is white. Kabiven consists of a three-chamber bag and an overbag. Between the inner bag and the overbag, an oxygen-absorbing pad is placed. The inner bag is separated into three chambers by peel-type welds. The contents of the three chambers must be mixed before use, by opening the peel-type welds.

Packaging Sizes

1 x 1026 ml, 4 x 1026 ml

1 x 1540 ml, 4 x 1540 ml

1 x 2053 ml, 4 x 2053 ml

1 x 2566 ml, 3 x 2566 ml

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder

Fresenius Kabi AB

SE-751 74 Uppsala, Sweden

Responsible Person for Manufacturing

Fresenius Kabi AB

SE-751 74 Uppsala, Sweden

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last Review Date of this Leaflet: April 2019

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals.

Warnings and Precautions for Use

To avoid the risk associated with a too rapid infusion rate, it is recommended to perform a continuous and well-controlled infusion, if possible using a volumetric pump.

Given the high risk of infection associated with the use of a central vein, strict aseptic precautions should be taken to avoid any contamination during the insertion of the catheter and handling.

Monitor serum glucose, electrolyte, and osmolarity levels, as well as fluid balance, acid-base balance, and liver enzyme tests.

In the event of any sign or symptom of anaphylactic reaction (such as fever, chills, skin rash, or dyspnea), 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.

Administration Method

Intravenous route, infusion in a central vein.

Infusion Rate

The maximum infusion rate for glucose is 0.25 g/kg pc/h.

The amino acid dosage should not exceed 0.1 g/kg pc/h.

The lipid dosage should not exceed 0.15 g/kg pc/h.

The infusion rate should not exceed 2.6 ml/kg body weight/hour (corresponding to 0.25 g of glucose, 0.09 g of amino acids, and 0.1 g of lipids/kg body weight). The recommended infusion period is 12-24 hours.

Precautions for Disposal

Do not use the container if it is not intact. Use only if the glucose and amino acid solutions are transparent and colorless or slightly yellowish, and the lipid emulsion is white and homogeneous. The contents of the three separated chambers must be mixed before use and prior to any addition made through the medication port.

After separating the peel-type welds, the bag must be inverted several times to ensure a homogeneous mixture that does not show evidence of phase separation.

For single use only. Any remaining mixture after infusion should be discarded.

Compatibility

There are data on compatibility in defined quantities with the branded products Dipeptiven, Supliven, Glycophos, Vitalipid Adultos/Infantil, and Soluvit, as well as generic electrolytes in defined concentrations. When adding electrolytes, the quantities already present in the bag should be taken into account to meet the patient's clinical needs. The data generated support the addition to the activated bag according to the summary table below:

Compatibility established for 8 days, i.e., 6 days of storage at 2-8°C followed by 48 hours at 20-25°C

1.includes the quantities of all products

Nota: This table is intended to indicate compatibility. It is not a dosage guide. Before prescribing, consult the approved technical dossier for branded products.

There are data on compatibility with other additives and the conservation time of the different mixtures, available on request.

Admixtures should be added aseptically.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Expiry Date after Mixing the Chambers of the Bag

After opening the peel-type welds, a chemical and physical stability of the three-chamber bag mixture has been demonstrated for 48 hours at 20-25°C, including administration time. From a microbiological point of view, the product should be used immediately. If not used immediately, the shelf life until use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixture was prepared in controlled and validated aseptic conditions.

Expiry Date after Mixing with Additives

After breaking the peel-type welds and mixing the three solutions, additives can be added through the medication port. A physical and chemical stability in use of the three-chamber bag mixture with additives has been demonstrated for a maximum of 8 days, i.e., 6 days at 2-8°C followed by 48 hours at 20-25°C, including administration time.

From a microbiological point of view, the product should be used immediately after adding the additives. If not used immediately, the shelf life until use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixture was prepared in controlled and validated aseptic conditions.

Kabiven Instructions for Use

The Bag

1. Notches in the overbag
2. Hangar
3. Ring for hanging the bag
4. Peel-type welds
5. Port without outlet (only used during manufacturing)
6. Medication port
7. Infusion port
8. Oxygen-absorbing pad

1.Removing the Overbag

• To remove the overbag, hold it in a horizontal position and tear along the notch towards the ports along the upper edge (A).
• Then, simply tear along the container; separate the overbag and discard it along with the oxygen-absorbing pad (B).

1. Mixing

• Place the bag on a flat surface.
• Roll the bag from the hangar towards the ports, first with the right hand and then applying constant pressure with the left hand until the vertical peel-type welds open. The vertical peel-type welds open due to the pressure of the liquid. The peel-type welds can also be opened before removing the overbag.

Nota:the liquids mix easily even if the horizontal weld remains closed.

• Mix the contents of the three chambers by inverting the bag three times until the components are completely mixed.

1. Finalizing the Preparation

• Place the bag back on a flat surface. Just before injecting the additives, break the white medication port by the arrow mark (A).

Nota:The membrane of the medication port is sterile

• Hold the base of the medication port. Insert the needle, inject the additives (of known compatibility) through the center of the injection point (B).
• • Mix thoroughly between each addition, inverting the bag three times. Use syringes with 18-23 gauge needles and a maximum length of 40 mm.

• Just before inserting the infusion set, break the blue infusion port by the arrow mark (A).

Nota:The membrane of the infusion port is sterile

• Use a non-ventilated infusion set or close the air inlet of the ventilated set.
• Hold the base of the infusion port.
• Insert the cannula through the infusion port. The cannula should be fully inserted to ensure retention.

Nota:The inner part of the infusion port is sterile

1. Hanging the Bag

Hang the bag by the ring below the hangar.