Kabiven infusion emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Kabiven infusion emulsion

Read the entire 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, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Kabiven is and what it is used for
2. What you need to know before using 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 supplied in a three-compartment bag with an overpouch. Kabiven contains the following medicinal components: amino acids (building blocks used to make proteins), lipids, glucose, and electrolytes. It provides energy (in the form of sugar and lipids) and amino acids directly into your bloodstream when you are unable to feed normally.

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

2. What you need to know before starting to use Kabiven

Do not use Kabiven:

• if you are allergic to the active substances or to any of the components of this medicine (listed in section 6).
• if you are allergic to products containing egg, soy, or peanut
• if you have excess fat substances (such as cholesterol) in your blood
• if you have severely impaired liver function
• if you are suffering from acute shock (resulting in significant blood loss or allergic reaction)
• if you have bleeding disorders associated with a known condition (such as hemophagocytic syndrome) or if your blood does not clot properly
• if you have a condition in which your body has difficulty utilizing proteins or amino acids
• if you have severe kidney problems
• if you have hyperglycemia (too much sugar in your blood) requiring administration of more than 6 units of insulin per hour
• if you have elevated levels of electrolytes (salts) in your blood
• if you have metabolic acidosis (acid levels in your body fluids and tissues are too high)
• if you have excess fluid in your body (overhydration)
• if you have fluid in your lungs (acute pulmonary edema)
• if you are in a coma
• if you have heart problems
• if you are dehydrated with low salt levels
• if you have severe 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:

• impaired liver function
• uncontrolled diabetes
• a condition in which your body has difficulty properly utilizing lipids
• kidney impairment
• any disorder of the pancreas
• thyroid problems – hypothyroidism
• sepsis (a condition in which your body is suffering from an infection)
• your body has difficulty eliminating electrolytes
• a condition in which there is insufficient oxygen in your body cells
• increased serum osmolarity

If during the infusion you develop fever, skin rash, chills, or difficulty breathing, inform healthcare personnel immediately. These symptoms may be caused by an allergic reaction or by receiving too much medication (see section 4).

This medicine may affect the results of other tests you undergo. It is important to inform the doctor performing the tests that you are receiving Kabiven.

Your doctor may regularly perform blood tests to ensure your body is properly receiving Kabiven.

Children

Kabiven must 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 recently taken, or might need to take any other medicines.

Tell your doctor if you are taking:

• a medicine called heparin, used to prevent blood clots and help dissolve existing clots
• warfarin, or vitamin K1 found in soybean oil, which may affect blood clotting
• insulin for the treatment of diabetes

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. The safety of Kabiven during pregnancy and breastfeeding has not been established. If intravenous nutrition (parenteral nutrition) is required during pregnancy or breastfeeding, your doctor will only administer Kabiven after careful consideration.

Driving and using machines

Kabiven is not expected to affect the ability to drive or operate machinery.

3. How to use Kabiven

You will receive your medication as an infusion given only through a central vein. The dose of Kabiven and the bag size used depend on your body weight in kilograms and your body's ability to utilize lipids and sugar. Kabiven will be infused slowly over a period of 12–24 hours. Your doctor will determine 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 are given more Kabiven than you should

It is highly unlikely that you will receive more infusion than intended, as your doctor or nurse will monitor you during treatment. Effects of an overdose may include nausea, vomiting, chills, and fluid retention. Hyperglycemia (too much sugar in your blood) and electrolyte disturbances have also been reported. In the case of overdose, there is a risk of receiving too many lipids. This is known as "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 rate.

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

4. Possible adverse effects

Like all medicines, Kabiven can cause adverse effects, although not everyone gets 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 hives and itching appears on 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)

• slight increase in body temperature

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

• chills
• fatigue
• stomach pain
• headache
• feeling unwell
• increased liver enzymes. Your doctor will inform you 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
• blood disorders

Lipid overload syndrome

This could occur if your body has difficulty utilizing lipids and you have received too much Kabiven. It may also occur due to a sudden change in your condition (such as kidney problems or infection). Possible symptoms are fever, elevated lipid levels in your blood, cells, and tissues, disturbances in multiple organs, and coma. All these symptoms usually resolve if the infusion is stopped.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Kabiven

Keep this medicine out of the sight and reach of children.

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

The emulsion must not be used after the expiry date stated on the label. Any remaining unused emulsion must be disposed of according to authorized hospital procedures.

6. Contents of the package and other information

Composition of Kabiven

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

• The active substances are

• The other ingredients are

Purified egg phospholipids
Glycerol
Sodium hydroxide
Glacial acetic acid
Water for injections.

Appearance of the medicinal product and contents of the pack

Glucose and amino acid solutions are clear and colourless or slightly yellow, and the lipid emulsion is white. Kabiven consists of a three-compartment bag and an overpouch. An oxygen absorber is placed between the inner bag and the overpouch. The inner bag is divided into three compartments by peelable seals. The contents of the three compartments must be mixed prior to use by opening the peelable seals.

Pack 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

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi AB
SE-751 74 Uppsala, Sweden

Manufacturer

Fresenius Kabi AB
SE-751 74 Uppsala, Sweden

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the most recent review of this summary: April 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals

Warnings and precautions for use

To avoid the risk associated with too rapid an infusion rate, it is recommended that a continuous and carefully controlled infusion be performed, preferably using a volumetric pump.

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

Serum glucose, electrolytes, and osmolarity levels, as well as fluid balance, acid-base balance, and liver enzyme tests, should be monitored.

If any sign or symptom of an anaphylactic reaction occurs (such as fever, chills, skin rash, or dyspnea), the infusion must be stopped immediately.

Kabiven must not be administered simultaneously with blood through the same infusion set, due to the risk of pseudoagglutination.

Method of administration

Intravenous route, infusion into a central vein.

Infusion rate

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

The dosage of amino acids should not exceed 0.1 g/kg body weight/h.

The dosage of lipids should not exceed 0.15 g/kg body weight/h.

The infusion rate must 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/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 clear and colourless or slightly yellow, and the lipid emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use and prior to any addition made through the additive port.

After separation of the peel seals, the bag should be inverted several times to ensure a homogeneous mixture without evidence of phase separation.

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

Compatibility

Compatibility data exist for defined quantities with the branded products Dipeptiven, Supliven, Glycophos, Vitalipid Adult/Infant, Soluvit, and generic electrolytes at defined concentrations. When adding electrolytes, the amounts already present in the bag must be considered to meet the patient's clinical requirements. The data generated support additions to the activated bag according to the summary table shown below:

Stable compatibility range for 8 days, i.e., 6 days of storage at 2–8 °C followed by 48 hours at 20–25 °C.

1. Includes quantities of all products

Note: This table is intended to indicate compatibility. It is not a dosing guide. For products with brand names, consult the approved product information before prescribing.

Data are available on compatibility with other additives and on the storage duration of various mixtures; these are available upon request.

Additions must be carried out aseptically.

Any unused medication and all materials that have come into contact with it should be disposed of in accordance with local regulations.

Shelf life after mixing the compartments of the bag

After opening the peel seals, chemical and physical stability of the mixed three-chamber bag has been demonstrated for 48 hours at 20–25°C, including administration time. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time prior to use and the conditions for such storage are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additives

After breaking the peel seals and mixing the three solutions, additions may be made via the medication addition port. Physicochemical stability in use of the mixed three-chamber bag with additives has been demonstrated for up to 8 days: i.e., 6 days at 2–8°C followed by 48 hours at 20–25°C, including administration time.

From a microbiological standpoint, the product should be used immediately after additions. If not used immediately, the storage time prior to use and the conditions for such storage are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.

Instructions for use of Kabiven

The bag

1. Notches on the overpouch
2. Hanger
3. Loop for hanging the bag
4. Peel seals
5. Non-functional port (used only during manufacturing)
6. Medication addition port
7. Infusion port
8. Oxygen absorber

1. Removal of the overpouch

• To remove the overpouch, hold it horizontally and tear at the notch towards the ports along the upper edge (A).
• Then simply tear along the package; separate and discard the overpouch together with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Roll the bag from the hanger end toward the port end, first with the right hand, then applying constant pressure with the left hand until the vertical peel seals have opened. The vertical peel seals open due to liquid pressure. The peel seals may also be opened before removing the overpouch.

Note: The liquids mix easily even if the horizontal seal remains closed.

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

3. Completion of preparation

• Place the bag back on a flat surface. Just before injecting additives, break the white addition port at the arrow-shaped mark (A).

Note: The membrane of the additive port is sterile.

• Hold the base of the additive port. Insert the needle and inject additives (known to be compatible) through the center of the injection site (B).
  • Mix thoroughly after each addition by inverting the bag three times. Use syringes with needles of gauge 18–23 and a maximum length of 40 mm.

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

Note: The membrane of the infusion port is sterile.

• Use a non-vented infusion set, or close the air inlet if using a vented set.
• Hold the base of the infusion port.
• Insert the spike through the infusion port. The spike must be fully inserted to ensure secure retention.

Note: The interior of the infusion port is sterile.

4. Hanging the bag

Hang the bag by the loop located beneath the hanger.