Package Insert: Information for the User

SmofKabiven Central Emulsion for Infusion

Read this entire package insert carefully before starting to use the medication, as it contains important information for you

-Keep this package insert, 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 package insert. See section 4.

SmofKabiven central is an emulsion for infusion that is administered into your blood through a drip (intravenous infusion). The product contains amino acids (components used in the formation of proteins), 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 central when other forms of nutrition are not sufficient or are not possible.

Do not use SmofKabiven central:

-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 central

contains soy oil

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

-if you have severe liver dysfunction

-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

central

-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 coagulation 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 children under 2 years old

Warnings and precautions

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

kidney problems

diabetes mellitus

pancreatitis (inflammation of the pancreas)

liver problems

hypothyroidism (thyroid problems)

sepsis (severe infection)

If during infusion, 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 monitor your blood, to control liver function tests and other values.

Children and adolescents

SmofKabiven central is not intended for newborns or children under 2 years of age.

SmofKabiven central can be administered to children from 2 to 16/18 years of age.

Use of Smofkabiven central 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 central during pregnancy or lactation. Therefore, SmofKabiven central should be administered to pregnant women or breastfeeding women only if the doctor considers it necessary. However, the use of SmofKabiven central may be considered during pregnancy and lactation if your doctor advises it.

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 central will be administered by a healthcare professional.

If you use more SmofKabiven central than you should

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

Like all medications, SmofKabiven central can 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, low blood pressure, skin eruptions, rashes (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Lips and skin with bluish 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 or pharmacist, 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. Store 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 bag and on the box. The expiration date is the last day of the month indicated.

SmofKabiven central contains

The active substances areg per 1000 ml

Alanine7.1

Arginine6.1

Glycine5.6

Histidine1.5

Isoleucine2.5

Leucine3.8

Lysine (as acetate)3.4

Methionine2.2

Phenylalanine2.6

Proline5.7

Serine3.3

Taurine0.5

Threonine2.2

Tryptophan1.0

Tyrosine0.20

Valine3.1

Calcium chloride (as dihydrate)0.28

Sodium glycerophosphate (as hydrate)2.1

Magnesium sulfate (as heptahydrate)0.61

Potassium chloride2.3

Sodium acetate (as trihydrate)1.7

Zinc sulfate (as heptahydrate)0.0066

Glucose (as monohydrate)127

Refined soybean oil11.4

Middle-chain triglycerides11.4

Refined olive oil9.5

Fish oil, rich in omega-3 fatty acids5.7

The other components are:

Glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (pH adjustment), sodium oleate, acetic acid (pH adjustment), hydrochloric 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 493 ml, 6 x 493 ml

1 x 986 ml, 4 x 986 ml

1 x 1477 ml, 4 x 1477 ml

1 x 1970 ml, 4 x 1970 ml

1 x 2463 ml, 3 x 2463 ml

Marketing authorization holder and responsible 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

or

Fresenius Kabi Austria GmbH, Graz, Austria

Last review date of this leaflet:

January 2023

For detailed and updated information on this medicinal product, please visit 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 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 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 tests.

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

SmofKabiven central 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, the following should be added to SmofKabiven central: trace elements, vitamins, and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven central), according to the patient's needs.

Dosage

Adults

Dosage:
The dosage range of 13-31 ml SmofKabiven central/kg pc/day will provide 0.6-1.6 g of amino acids/kg pc/day (corresponding to 0.10-0.25 g nitrogen/kg pc/day) and 14-35 kcal/kg pc/day of total energy (12-27 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 2.0 ml/kg pc/h (corresponding to 0.25 g of glucose, 0.10 g of amino acids, 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 daily dose recommended is 35 ml/kg pc/day.

Pediatric population

Children (2-11 years)

Dosage:

The dosage of up to 35 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 2.4 ml/kg pc/h (corresponding to 0.12 g of amino acids/kg/h, 0.30 g of glucose/kg/h, and 0.09 g of lipids/kg/h). At the maximum recommended infusion rate, do not use infusion periods longer than 14 hours and 30 minutes, 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 35 ml/kg pc/day.

Adolescents (12-16/18 years)

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

Precautions for use

Do not use the container if it is damaged.

Only use 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 should be mixed before use, and before any additions are made through the addition port.

After opening the peel-type seals, the bag should be inverted several times to ensure a homogeneous mixture, which should not show any evidence of phase separation.

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

Compatibility

There are compatibility data 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 amounts already present in the bag should be taken into account to meet the patient's clinical needs.

The data generated support the addition to the activated bag according to the summary table below.

1Includes the amounts of all products.

2Admixtures of Glycophos can be doubled with a stability of 7 days, i.e., 6 days of storage at 2-8°C followed by 24 hours at 20-25°C.

Note: This table is intended to indicate compatibility. It is not a dosage guide. Before prescribing, consult the approved technical dossier for the product with a commercial name.

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

Additions should be made 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 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 8 days, i.e., 6 days at 2-8°C followed by 48 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 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 aseptic and validated conditions.

Instructions for the use of SmofKabiven central

The bag

493 ml, 986 ml, 1477 ml, 1970 ml, 2463 ml

1. Notches on the outer bag

2. Spout

3. Hanging ring

4. Peel-off seals

5. Blind port (used only during manufacturing)

6. Addition port

7. Infusion port

8. Oxygen absorber

1. Opening the outer bag

•To remove the outer bag, hold it in a horizontal position and tear along the notch towards the ports along the top edge (A)

•Then, simply tear along the container; separate the outer bag 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 pressure of the liquid. The peel seals can also be opened before removing the outer bag.

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

493 ml, 986 ml, 1477 ml, 1970 ml, 2463 ml

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

3.Finalizing the preparation:

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

Nota:the addition port membrane is sterile.

•Hold the base of the addition port. Insert the needle, inject the additives (of known compatibility) through the center of the injection point (B).

•Mix thoroughly after 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 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.Hang the bag

•Hang the bag by the ring below the hanging ring

.