SMOFKabiven Extra Nitrogen without Electrolytes emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SmofKabiven extra Nitrogen without electrolytes emulsion for infusion

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 side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What SmofKabiven extra Nitrogen without electrolytes is and what it is used for
2. What you need to know before using SmofKabiven extra Nitrogen without electrolytes
3. How to use SmofKabiven extra Nitrogen without electrolytes
4. Possible side effects
5. How to store SmofKabiven extra Nitrogen without electrolytes
6. Contents of the pack and other information

1. What SmofKabiven extra Nitrogen without electrolytes is and what it is used for

SmofKabiven extra Nitrogen without electrolytes is an infusion emulsion administered into your blood through a drip (intravenous infusion). The product contains amino acids (components used in protein formation), glucose (carbohydrates), and lipids (fats), all contained in a plastic bag, and can be administered to adults and children aged 2 years and older.

A healthcare professional will administer SmofKabiven extra Nitrogen without electrolytes to you when other forms of nutrition are insufficient or not possible.

2. What you need to know before using SmofKabiven extra Nitrogen without electrolytes

Do not use SmofKabiven extra Nitrogen without electrolytes:

• if you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6)
• if you are allergic to fish or egg
• if you are allergic to peanuts or soy, you should not use this product. SmofKabiven extra Nitrogen without electrolytes contains soybean oil
• if you have too many lipids in your blood (hyperlipidemia)
• if you have severe liver disease
• if you have blood clotting problems (coagulation disorders)
• if your body has difficulty utilizing amino acids
• if you have severe kidney disease without possibility of dialysis
• if you are in acute shock
• if you have too much sugar in your blood (hyperglycemia) that is not controlled
• if you have fluid in your lungs (acute pulmonary edema)
• if you have too much fluid in your body (hyperhydration)
• if you have heart failure that is not being treated
• if you have a defect in your blood clotting system (hemophagocytic syndrome)
• if you are in an unstable condition, such as after severe trauma, uncontrolled diabetes mellitus, acute heart attack, stroke, blood clot, metabolic acidosis (a disorder leading to excess acid in your blood), severe infection (severe sepsis), coma, or if you do not have enough fluid in your body (hypotonic dehydration)
• in newborn or children under 2 years of age

Warnings and precautions

Talk to your doctor before using SmofKabiven extra Nitrogen without electrolytes if you have:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothyroidism (thyroid problems)
• sepsis (severe infection)

If during the infusion you develop fever, skin rash, swelling, difficulty breathing, chills, sweating, nausea, or vomiting, inform your healthcare professional immediately, as these symptoms could be due to an allergic reaction or because you are receiving too much of the medicine.

Your doctor will need to regularly monitor your blood through tests assessing liver function and other parameters.

Children and adolescents

SmofKabiven extra Nitrogen without electrolytes is not intended for newborns or children under 2 years of age.

SmofKabiven extra Nitrogen without electrolytes may be administered to children aged 2 to 16/18 years.

Use of SmofKabiven extra Nitrogen without electrolytes with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There is no information available on the use of SmofKabiven extra Nitrogen without electrolytes during pregnancy or breastfeeding. Therefore, SmofKabiven extra Nitrogen without electrolytes should only be given to pregnant or breastfeeding women if considered necessary by the doctor. However, the use of SmofKabiven extra Nitrogen without electrolytes may be considered during pregnancy and breastfeeding if advised by your doctor.

Driving and using machines

Not applicable, as this medicine is administered in a hospital setting.

3. How to use SmofKabiven extra Nitrogen without electrolytes

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will individually determine the dose for you depending on your body weight and condition. SmofKabiven extra Nitrogen without electrolytes will be administered by a healthcare professional.

If you use more SmofKabiven extra Nitrogen without electrolytes than you should

It is very unlikely that you will receive too much of the medicine, as SmofKabiven extra Nitrogen without electrolytes will be administered by a healthcare professional.

4. Possible adverse effects

Like all medicines, SmofKabiven extra Nitrogen without electrolytes can cause adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 patients): a slight increase in body temperature.

Uncommon (may affect up to 1 in 100 patients): elevated blood (plasma) levels of liver components, loss of appetite, nausea, vomiting, chills, dizziness, and headache.

Rare (may affect up to 1 in 1,000 patients): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia). Hypersensitivity reactions (which may cause symptoms such as swelling, fever, drop in blood pressure, skin rash, hives (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Bluish discoloration of lips and skin (due to lack of oxygen in the blood). Pain in the neck, back, bones, chest, and lumbar area.

Reporting of adverse effects

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

5. Storage of SmofKabiven extra Nitrogen without electrolytes

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

Keep in the overpouch. Do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date stated on the bag and carton. The expiry date refers to the last day of the month indicated.

6. Contents of the container and additional information

SmofKabiven extra Nitrogen without electrolytes contains

The other components are: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (pH adjustment), sodium oleate, glacial acetic acid (pH adjustment), hydrochloric acid (pH adjustment), and water for injections.

Appearance of the product and contents of the container

Glucose and amino acid solutions are clear, colourless or slightly yellow, and free from particles. The lipid emulsion is white and homogeneous.

Container sizes:

1 x 506 ml, 6 x 506 ml

1 x 1012 ml, 4 x 1012 ml

1 x 1518 ml, 4 x 1518 ml

1 x 2025 ml, 4 x 2025 ml

1 x 2531 ml, 3 x 2531 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18.

08005 Barcelona (Spain)

Manufacturer

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden

Date of the most recent review of this summary: March 2023

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

This information is intended for healthcare professionals only:

Special warnings and precautions for use

To avoid risks associated with excessively rapid infusion rates, continuous and carefully controlled infusion is recommended, preferably using an infusion pump.

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

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

Infusion must be stopped immediately if any signs or symptoms of anaphylactic reaction (such as fever, chills, rash, or dyspnea) occur.

SmofKabiven extra Nitrogen without electrolytes should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.

Method of administration

Intravenous use, infusion into a central vein.

To provide complete parenteral nutrition, trace elements and vitamins must be added to SmofKabiven extra Nitrogen without electrolytes according to the patient's needs.

Dosage

Adults

Dosage:

A dosage range of 13–31 ml SmofKabiven extra Nitrogen without electrolytes/kg body weight/day will provide 0.14–0.32 g nitrogen/kg body weight/day (equivalent to 0.85–2.0 g amino acids/kg body weight/day) and 12–28 kcal/kg body weight/day of total energy (8–19 kcal/kg body weight/day of non-protein energy).

Infusion rate

The usual maximum infusion rate for glucose is 0.25 g/kg body weight/h, for amino acids 0.1 g/kg body weight/h, and for lipids 0.15 g/kg body weight/h.

The infusion rate must not exceed 1.5 ml/kg body weight/hour (equivalent to 0.13 g glucose, 0.10 g amino acids, and 0.04 g lipids/kg body weight/h). The recommended infusion period is 14–24 hours.

Intradialytic parenteral nutrition (IDPN)

The maximum infusion rate for intradialytic parenteral nutrition (IDPN) in stable adult patients on chronic renal replacement therapy is 3.0 ml/kg/h (equivalent to 0.20 g amino acids/kg/h, 0.25 g glucose/kg/h, and 0.09 g lipids/kg/h). The infusion volume in IDPN should be guided by the difference between oral food intake and recommended nutrient intake, unavoidable nutrient losses due to renal replacement therapy, and the individual patient's metabolic tolerance. The usual infusion time for use in IDPN is 3 to 5 hours, depending on patient needs and the planned duration of the renal replacement therapy session. The recommended maximum daily dose remains unchanged.

Maximum daily dose:

The maximum daily dose varies depending on the patient's clinical condition and may even change from day to day. The recommended maximum daily dose is 31 ml/kg body weight/day.

Paediatric population

Children (2–11 years)

Dosage:

Doses up to 31 ml/kg body weight/day should be regularly adjusted according to the paediatric patient's requirements, which vary more than in adult patients.

Infusion rate:

The maximum infusion rate is 1.8 ml/kg body weight/h (equivalent to 0.12 g amino acids/kg/h, 0.15 g glucose/kg/h, and 0.05 g lipids/kg/h). At the recommended maximum infusion rate, infusion periods longer than 17 hours should not be used except in exceptional cases and under close monitoring.

The recommended infusion period is 12–24 hours.

Maximum daily dose:

The maximum daily dose varies with the patient's clinical condition and may even change from day to day. The maximum daily dose is 31 ml/kg body weight/day.

Adolescents (12–16/18 years)

SmofKabiven extra Nitrogen without electrolytes may be used in adolescents in the same way as in adults.

Disposal precautions

Do not use if the container is damaged.

Use only if the amino acid and glucose solutions are clear, colourless or slightly yellow, and if the lipid emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use and before any addition through the additive port. After opening 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 are available for the branded products Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adult/Infant, and Soluvit lyophilised, in defined quantities, and with electrolyte solutions at defined concentrations. When adding electrolytes, the amounts already present in the bag must be taken into account according to the patient's clinical needs. The generated data support additions to the activated bag according to the following table:

Stable compatibility range for 7 days, i.e., 6 days of storage at 2–8°C followed by 24 hours at 20–25°C.

1 Includes quantities for all products.

Note: This table indicates compatibility. It is not a dosing guideline.

For products with brand names, consult the approved product information before prescribing.

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

Additions must be made aseptically.

Shelf life after mixing the chambers of the bag

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

Shelf life after mixing with additives

Physicochemical stability in use of the mixed three-chamber bag with additives (see section 6.6) has been demonstrated for up to 7 days—specifically, 6 days at 2–8°C followed by 24 hours at 20–25°C, including the duration of administration. From a microbiological standpoint, the product should be used immediately after additives are added. If not used immediately, the storage time before use and the conditions prior to use are the responsibility of the user. Storage time should normally not exceed 24 hours at 2–8°C, unless addition of supplements has been performed under controlled and validated aseptic conditions.

Instructions for use of SmofKabiven extra Nitrogen without electrolytes

The bag

506 ml, 1012 ml, 1518 ml, 2025 ml, 2531 ml

1. Notches on the overpouch

2. Handle

3. Hanging hole

4. Breakable seals

5. Blind port (used only during manufacturing)

6. Additive port

7. Infusion port

8. Oxygen absorber

9. Opening the overpouch

• To remove the overpouch, hold it horizontally and tear along the notch towards the ports along the upper edge (A).
• Then 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 using the right hand, then applying constant pressure with the left hand until the vertical peel seals open. The vertical peel seals open due to liquid pressure.

The peel seals may also be opened before removing the overpouch.

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

506 ml, 1012 ml, 1518 ml, 2025 ml, 2531 ml

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

3. Completion of preparation:

• Place the bag back on a flat surface. Shortly before injecting additives, break the white additive port at the arrow mark (A).

Note: The membrane of the additive port is sterile.

• Hold the base of the additive port. Insert the needle and inject additives (of known compatibility) into 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.

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

Note: The membrane of the infusion port is sterile.

• Use a non-vented infusion set or close the air inlet of a vented infusion 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 ring located beneath the hanger.