Label: Information for the User

SmofKabiven Low Osmo Peripheral emulsion for infusion

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

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

SmofKabiven Low Osmo Periférico 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 (fat) and salts (electrolytes), in a plastic bag and can be administered to adults and children aged 2 years or older.

A healthcare professional will administer SmofKabiven Low Osmo Periférico when other forms of nutrition are not sufficient or are not possible.

Do not use SmofKabiven Low Osmo Periférico:

• 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, do not use this product. SmofKabiven Low Osmo Periférico 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) that are included in SmofKabiven Low Osmo Periférico
• if you have fluid in your lungs (acute pulmonary edema)
• if you have too much fluid in your body (hyperhydration)
• if you have untreated heart failure
• if you have a defect in your blood clotting system (hemophagocytic syndrome)
• if you are in an 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 Low Osmo Periférico 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 monitor your blood, through liver function tests and other values.

Children and adolescents

SmofKabiven Low Osmo Periférico is not intended for newborns or children under 2 years old. SmofKabiven Low Osmo Periférico can be administered to children from 2 to 18 years old.

Use of SmofKabiven Low Osmo Periférico with other medications

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

There is no information on the use of SmofKabiven Low Osmo Periférico during pregnancy. SmofKabiven Low Osmo Periférico should be administered to pregnant women only if the doctor considers it absolutely necessary. SmofKabiven Low Osmo Periférico may be considered for use during pregnancy if your doctor advises it.

No data is available on exposure in breastfeeding women.

The components and metabolites of parenteral nutrition, such as SmofKabiven Low Osmo Periférico, are excreted in human milk. Parenteral nutrition may be necessary during breastfeeding. SmofKabiven Low Osmo Periférico should only be administered to breastfeeding women when the doctor has weighed the potential risks and benefits.

Driving and operating machinery

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 Low Osmo Periférico will be administered by a healthcare professional.

If you use more SmofKabiven Low Osmo Periférico than you should

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

Like all medications, this medication 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, inflammation in superficial peripheral veins connected to the injection site.

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, low 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 the 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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.

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 label and the box. The expiration date is the last day of the month indicated.

SmofKabiven Low Osmo Periférico contains

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

Appearance of the product and contents of the container

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

Container sizes:

1 x 850 ml, 5 x 850 ml

1 x 1,400 ml, 4 x 1,400 ml

1 x 1,950 ml, 4 x 1,950 ml

1 x 2,500 ml, 3 x 2,500 ml

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18.

08005 Barcelona (Spain)

Manufacturer responsible

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: July 2023

The detailed and updated information on this medicinal product is available on 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 only for healthcare professionals:

Warnings and precautions for special 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 pump.

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

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

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

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

Thrombophlebitis may occur if peripheral veins are used for infusion. The catheter insertion site should be monitored daily to detect local signs of thrombophlebitis.

Administration form

Intravenous, infusion in a peripheral or central vein.

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

Dosage

Adults

Dosage:

The dosage range of 20 ml - 40 ml of SmofKabiven Low Osmo Periférico /kg pc/day corresponds to 0.08-0.16 g nitrogen/kg pc/day (0.5-1.0 g of amino acids/kg pc/day) and 14-29 kcal/kg pc/day of total energy (12-25 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 3.7 ml/kg pc/hour (corresponding to 0.25 g of glucose, 0.09 g of amino acids, and 0.13 g of lipids/kg pc/h). 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 40 ml/kg pc/day.

Pediatric population

Children (2-11 years)

Dosage:

The dose of up to 40 ml/kg pc/day should be adjusted regularly according to the pediatric patient's needs, which vary more than those of adult patients.

Infusion rate:

The maximum recommended infusion rate is 4.0 ml/kg pc/h (corresponding to 0.10 g of amino acids/kg/h, 0.27 g/glucose/kg/h, and 0.14 g lipids/kg/h). At the maximum recommended infusion rate, do not use infusion periods longer than 10 hours, except in exceptional cases and under close monitoring.

Infusion period:

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 40 ml/kg pc/day.

Adolescents (12-18 years)

SmofKabiven Low Osmo Periférico can be used in adolescents in the same way as in adults.

Precautions for disposal

Do not use if the container is damaged.

Use only if the amino acid and glucose solutions are transparent and colorless or slightly yellowish, and 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 only. Any remaining mixture should be discarded after infusion.

Compatibility

There are data on compatibility with the brand products Dipeptiven, Supliven, Vitalipid Adults, Soluvit (lyophilized), and Glycophos in defined quantities and generic solutions of sodium or potassium in defined concentrations. When adding sodium, potassium, or phosphate, 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:

* Including the amounts already present in the bag

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

Admixtures should be added aseptically.

Period of validity after mixing

The physical and chemical stability of the three-chamber bag mixed for 36 hours at 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.

Period of validity after mixing with additives

From a microbiological point of view, the product should be used immediately after adding the additives. 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.

Instructions for the use of SmofKabiven Low Osmo Periférico

The bag

850 ml, 1,400 ml, 1,950 ml, 2,500 ml

1. Notches on the overbag

2. Handle

3. Hanging loop

4. Peelable 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 top edge (A)

•Then, simply tear along the container; 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 loop 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 pressure of the liquid. The peel seals may also open before removing the overbag.

Nota: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. Final preparation:

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

Nota:the infusion port membrane 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 its retention.

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

4. Hanging the bag

•Hang the bag by the loop under the hanging loop