Label: Information for the User

SmofKabiven extra Nitrogen emulsion for infusion

Read the entire label carefully before starting to use the medication, because it contains important information for you

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

SmofKabiven extra Nitrogen is a perfusion emulsion that is administered into your blood through an intravenous drip. The product contains amino acids (components used in protein formation), glucose (carbohydrates), lipids (fats) and salts (electrolytes), in a plastic bag and can be administered to adults and children aged 2 years and above.

A healthcare professional will administer SmofKabiven extra Nitrogen when other forms of nutrition are not sufficient or not possible.

Do not use SmofKabiven extra Nitrogen:

• if you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication (listed in section 6)
• if you are allergic to fish or eggs
• if you are allergic to peanuts or soy, you should not use this product. SmofKabiven extra Nitrogen contains soy oil
• if you have too much fat in your blood (hyperlipidemia)
• if you have severe liver dysfunction
• if you have problems with blood clotting (coagulation disorders)
• if your body has problems using amino acids
• if you have severe kidney disease without the 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 elevated levels of salts (electrolytes) in your blood (serum) included in SmofKabiven extra Nitrogen
• if you have fluid in your lungs (acute pulmonary edema)
• if you have too much fluid in your body (hyperhydration)
• if you have uncontrolled heart failure
• if you have a defect in your blood clotting system (hemophagocytic syndrome)
• if you are in a unstable situation, such as after a severe trauma, uncontrolled diabetes mellitus, acute heart attack, stroke, blood clot, metabolic acidosis (a condition that leads to too much acid in your blood), severe infection (severe sepsis), coma, and if you do not have enough fluid in your body (hypotonic dehydration).
• in newborns or children under 2 years old

Warnings and precautions

Consult your doctor before starting to use SmofKabiven extra Nitrogen 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 experience fever, skin rash, swelling, difficulty breathing, chills, sweating, nausea, or vomiting, report to your healthcare professional immediately, as these symptoms may be caused by an allergic reaction, or because you are receiving too much of the medication.

Your doctor will need to regularly check your blood, through liver function analysis and other values.

Children and adolescents

SmofKabiven extra Nitrogen is not intended for newborns or children under 2 years old.

SmofKabiven extra Nitrogen can be administered to children from 2 to 16/18 years old.

Use of SmofKabiven extra Nitrogen with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, even those acquired without a prescription.

Pregnancy and breastfeeding

There is no information on the use of SmofKabiven extra Nitrogen during pregnancy or lactation. Therefore, SmofKabiven extra Nitrogen should be administered to pregnant women or breastfeeding women only if the doctor considers it necessary. However, the use of SmofKabiven extra Nitrogen may be considered during pregnancy and lactation if your doctor advises it.

Driving and operating machines

This is not relevant, as this medication is administered in the hospital.

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

Your doctor will decide your individual dose based on your body weight and condition. SmofKabiven extra Nitrogen will be administered by a healthcare professional.

If you use more SmofKabiven extra Nitrogen than you should

It is very unlikely that you will receive too much medication, as SmofKabiven extra Nitrogen will be administered by a healthcare professional.

Like all medications, SmofKabiven extra Nitrogen may produce adverse effects, although not all people will experience them.

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

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

Rare(may affect up to 1 in 1000 patients): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia). Hypersensitivity reactions (which may cause symptoms such as swelling, fever, decreased blood pressure, skin eruptions, rashes (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Lips and skin with blue discoloration (due to lack of oxygen in the blood). Pain in neck, back, bones, chest, and lower back.

Reporting Adverse Effects

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

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

Keep in the outer packaging. Do not store at a temperature above 25°C. Do not freeze.

Do not use this medication after the expiration date that appears on the bag and on the box. The expiration date is the last day of the month indicated.

SmofKabiven extra Nitrogen 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 injection preparations.

Appearance of the product and contents of the packaging

The glucose and amino acid solutions are transparent, colorless, or slightly yellowish and free of particles. The lipid emulsion is white and homogeneous.

Packaging 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 responsible manufacturer

Marketing authorization holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18.

08005 Barcelona (Spain)

Responsible manufacturer

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden

Last review date of this leaflet: March 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Warnings and special precautions for use

To avoid the risks associated with too high infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible using a perfusion pump.

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

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

In case of any sign or symptom of anaphylactic reaction (such as fever, tremors, skin rash, or dyspnea) the infusion should be stopped immediately.

SmofKabiven extra Nitrogen should not be administered simultaneously with blood in the same infusion set, due to the risk of pseudoagglutination.

Administration route

Intravenous, infusion in a central vein.

To provide complete parenteral nutrition, oligoelements, vitamins, and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven extra Nitrogen) should be added to SmofKabiven extra Nitrogen according to the patient's needs.

Dosage

Adults

Dosage:

The dosage range of 13-31 ml SmofKabiven extra Nitrogen/kg pc/day will provide 0.14 – 0.32 g of nitrogen/kg pc/day (corresponding to 0.85 – 2.0 g of amino acids/kg pc/day) and 12 – 28 kcal/kg pc/day of total energy (8 – 19 kcal/kg pc/day of non-protein energy).

Infusion rate:

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

The infusion rate should not exceed 1.5 ml/kg pc/hour (corresponding to 0.13 g of glucose, 0.10 g of amino acids, and 0.04 g of lipids/kg pc/h). The recommended infusion period is 14 – 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 recommended daily dose is 31 ml/kg pc/day.

Pediatric population

Children (2-11 years)

Dosage:

The dose of up to 31 ml/kg pc/day should be adjusted regularly according to the pediatric patient's needs, which vary more than in adult patients.

Infusion rate:

The maximum infusion rate is 1.8 ml/kg pc/h (corresponding to 0.12 g of amino acids/kg/h, 0.15 g/glucose/kg/h, and 0.05 g lipids/kg/h). At the maximum recommended infusion rate, do not use infusion periods longer than 17 hours, 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 recommended daily dose is 31 ml/kg pc/day.

Adolescents (12-16/18 years)

SmofKabiven extra Nitrogen can be used in adolescents in the same way as in adults.

Precautions for disposal

Do not use if the packaging is damaged.

Use only if the amino acid and glucose solutions are transparent and colorless or slightly yellowish, and if the lipid emulsion is white and homogeneous. The contents of the three separate chambers should be mixed before use, and before any additions are made through the additive port. After opening the peel-type seals, the bag should be inverted several times to ensure a homogeneous mixture that does not show evidence of phase separation.

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

Compatibility

There are data on compatibility with the brand products Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adults/Infantil, and Soluvit lyophilized in defined quantities and solutions with defined electrolytes. When adding electrolytes, the amounts already present in the bag should be taken into account according to the patient's clinical needs. The data generated support the addition of the activated bag according to the following table:

1includes the amounts ofall products.

Nota: This table indicates compatibility. It is not a dosage guideline.

Before prescribing, consult the approved technical data sheet for the brand product.

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

Admixtures should be added aseptically.

Validity period after mixing the bag's chambers

The physical and chemical stability of the three-chamber bag mixed for 48 hours at 20-25°C has been demonstrated. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time 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 made in controlled and validated aseptic conditions.

Validity period after mixing with additives

The physical and chemical stability of the mixed three-chamber bag with additives (see section 6.6) has been demonstrated for up to 7 days, i.e., 6 days at 2-8°C followed by 24 hours at 20-25°C, including the duration of administration. From a microbiological point of view, the product should be used immediately after adding the supplements. If not used immediately, the storage time until use and the conditions prior to use are the responsibility of the user. The storage time should not normally exceed 24 hours at 2-8°C, unless the addition of the supplements was made in controlled and validated aseptic conditions.

Instructions for the use of SmofKabiven extra Nitrogen

The bag

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

1. Notches on the overbag

2. Handle

3. Hanging ring

4. Breakable seals

5. Blind port (used only during manufacturing)

6. Additive port

7. Infusion port

8. Oxygen absorber

1. Opening the overbag

•To remove the overbag, hold it horizontally and tear along the notch towards the ports along the top edge (A)

•Then, simply tear along the bag; separate the overbag and discard it along with the oxygen absorber (B).

2. Mixing

•Place the bag on a flat surface.

•Roll the bag from the hanging ring towards the ports, first with the right hand and then applying constant pressure with the left hand until the vertical peel seals open. The vertical peel seals open due to the liquid pressure. The peel seals may also open before removing the overbag.

Nota:the 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 the components are completely mixed.

3. Final preparation:

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

Nota:the additive port membrane is sterile.

•Hold the base of the additive 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 seal by the arrow mark (A).

Nota:the infusion port membrane is sterile.

•Use a non-ventilated infusion set or close the air intake 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 its retention.

Nota:the inner part of the infusion port is sterile.

4. Hanging the bag

•Hang the bag by the ring below the hanging ring