Prospecto: information for the user

SmofKabiven Peripheral emulsion for infusion

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect. 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 prospect. See section 4.

5Storage of SmofKabiven Peripheral

6.Contents of the container and additional information

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

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

No use SmofKabiven 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, you should not use this product. SmofKabiven Periférico contains soy oil.

-if you have too much fat in your blood (hyperlipidemia)

-if you have a severe liver disorder

-if you suffer from blood clotting problems (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), which is not controlled

-if you have elevated levels of salts (electrolytes) in your blood (serum) included in SmofKabiven 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 disorder 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 children under 2 years of age

Warnings and precautions

Consult your doctor before starting to use Smofkabiven periférico if you have:

-kidney problems

-diabetes mellitus

-pancreatitis (inflammation of the pancreas)

-liver problems

-hypothyroidism (thyroid problems)

-sepsis (severe infection)

If during the perfusion, fever, skin rash, swelling, difficulty breathing, chills, sweating, nausea, or vomiting appear, 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, to control liver function tests and other values.

Children and adolescents

SmofKabiven Periférico is not intended for newborns or children under 2 years of age. SmofKabiven Periférico can be administered in children from 2 to 16/18 years of age.

Use of Smofkabiven periférico with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those acquired without a prescription.

Pregnancy and lactation

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

It 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 Periférico will be administered by a healthcare professional.

If you use more SmofKabiven Periférico than you should:

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

Like all medications, SmofKabiven Periférico may produce adverse effects,

although not everyone will experience them.

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

Swelling in superficial peripheral veins in contact with the injection site.

Infrequent(may affect up to 1 in 100 patients): elevated levels in the 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, hives (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Lips and skin with a bluish discoloration (due to a lack of oxygen in the blood). Pain in the neck, back, bones, chest, and lumbar region.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 pouch. Do not store above 25°C. Do not freeze.

Do not use this medication after the expiration date that appears on the pouch and on the box.

The expiration date is the last day of the month indicated.

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

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 1.206 ml, 4 x 1.206 ml

1 x 1448 ml, 4 x 1448 ml

1 x 1.904 ml, 4 x 1.904 ml

Holder of the marketing authorization and responsible manufacturer

Holder:

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005 Barcelona (Spain)

Manufacturer:

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden

Fresenius Kabi Austria GmbH, AT-8055 Graz, Austria

For any information about this product, please contact the holder of the marketing authorization.

Last review date of this leaflet: March 2023

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This information is intended solely for healthcare professionals:

Warnings and special precautions for use

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

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

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

Immediately stop infusion in case of any sign or symptom of anaphylactic reaction (such as fever, tremors, skin rash, or dyspnea).

SmofKabiven 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 evaluated daily for local symptoms of thrombophlebitis.

Administration route

Intravenous, infusion in a peripheral vein or in a central vein.

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

Dosage

Adults

Dosage:
The dosage range of 20-40 ml SmofKabiven periférico/kg pc/day will provide 0.6-1.3 g of amino acids/kg pc/day (corresponding to 0.10-0.20 g nitrogen/kg pc/day) and 14-28 kcal/kg pc/day of total energy (11-22 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 3.0 ml/kg pc/hour (corresponding to 0.10 g of amino acids, 0.21 g of glucose, and 0.08 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 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 requirements, which vary more than those of adult patients.

Infusion rate:

The maximum infusion rate is 3.0 ml/kg pc/h (corresponding to 0.10 g of amino acids/kg/h, 0.21 g/glucose/kg/h, and 0.08 g lipids/kg/h).

The recommended infusion period is 12-24 hours.

If the maximum recommended daily dose is used, the dose should be infused for a period of at least 13 hours to avoid exceeding the recommended maximum infusion rate, except in special cases.

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.

Adolescents (12-16/18 years)

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

Precautions for use

Do not use the container if it 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 chambers must 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 after infusion should be discarded.

Compatibility

There are data on compatibility in defined quantities with the commercially available products Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adultos/Infantil, and Soluvit lyophilized and 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 of electrolytes to the activated bag according to the summary table below.

1includes the quantities of all products.

Nota: This table is intended to indicate compatibility. It is not a dosage guide. Before prescribing products with a commercial name, consult the approved technical data sheet.

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

Aditivos must be added aseptically.

Validity period after mixing the chambers of the bag

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 it is 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 has been demonstrated for 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 additives. If it is 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 mixture was made in controlled and validated aseptic conditions.

Instructions for the use of SmofKabiven Periférico

The bag

1. Peel-type seals
2. Hangar
3. Ring for hanging the bag
4. Peel-type seal
5. Port without outlet (only used during manufacturing)
6. Additive port
7. Infusion port
8. Oxygen absorber

1. Extraction of the overbag

• To extract the overbag, hold it in a horizontal position and tear along the mark towards the ports along the upper 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 firmly from the hangar towards the ports, first with the right hand and then with constant pressure from the left hand until the vertical peel-type seal breaks. The peel-type seal opens due to the fluid pressure. The peel-type seals may also open before removing the overbag.

Nota:the liquids mix easily even if the horizontal peel-type seal remains closed.

• Mix the contents of the three chambers by inverting the bag three times until the components are fully 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 membrane of the additive port 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 bags three times. Use syringes with 18-23 gauge needles and a maximum length of 40 mm.

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

Nota:the membrane of the infusion port is sterile.

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

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

4. Hanging the bag

• Hang the bag by the ring below the hangar.