SmofKabiven without electrolytes central emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SmofKabiven without electrolytes central emulsion for infusion

Read all of this 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

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

A healthcare professional will administer SmofKabiven without central electrolytes when other forms of nutrition are not adequate or not possible.

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

Do not use SmofKabiven without electrolytes central:

• 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 without
  electrolytes central contains soybean oil.

• if you have too many lipids in your blood (hyperlipidemia)

• if you have severe liver disease

• if you have blood coagulation disorders (coagulation abnormalities)

• if your body has problems utilizing amino acids

• if you have severe renal 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 the 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 coagulation system (hemophagocytic syndrome)

• if you are in an unstable condition, such as after severe trauma, uncontrolled diabetes mellitus,
  acute myocardial infarction, stroke, blood clot, metabolic acidosis (a disorder leading to excess acid in the blood), severe infection (severe sepsis), coma, or if you do not have enough fluid in your body (hypotonic dehydration).

• in children under 2 years of age.

Warnings and precautions

Talk to your doctor before starting to use SmofKabiven without electrolytes central if you have:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothyroidism (thyroid problems)
• sepsis (serious 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 tests, including liver function tests and other parameters.

Children and adolescents

SmofKabiven without electrolytes central is not intended for newborn infants or children under 2 years of age. SmofKabiven without electrolytes central may be administered to children aged 2 to 16/18 years.

Use of SmofKabiven without electrolytes central with other medicines

Inform 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 without electrolytes central during pregnancy or breastfeeding. Therefore, SmofKabiven without electrolytes central should only be administered to pregnant or breastfeeding women if considered necessary by the doctor. However, the use of SmofKabiven without electrolytes central may be considered during pregnancy and breastfeeding if advised by your doctor.

Driving and use of machines

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

3. How to use SmofKabiven without central electrolytes

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

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

If you are given more SmofKabiven without central electrolytes than you should receive

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

4. Possible adverse effects

Like all medicines, SmofKabiven without central electrolytes may 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 rashes, hives (red, inflamed areas), flushing, 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SmofKabiven without electrolytes central

Keep this medicine out of the sight and reach of children. Store 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 is the last day of the month indicated.

6. Package Contents and Additional Information

SmofKabiven without electrolytes central contains

Active substances per 1000 ml:

Alanine 7.1 g
Arginine 6.1 g
Glycine 5.6 g
Histidine 1.5 g
Isoleucine 2.5 g
Leucine 3.8 g
Lysine (as acetate) 3.4 g
Methionine 2.2 g
Phenylalanine 2.6 g
Proline 5.7 g
Serine 3.3 g
Taurine 0.5 g
Threonine 2.2 g
Tryptophan 1.0 g
Tyrosine 0.20 g
Valine 3.1 g
Glucose (as monohydrate) 127 g
Refined soybean oil 11.4 g
Medium-chain triglycerides 11.4 g
Refined olive oil 9.5 g
Fish oil rich in omega-3 fatty acids 5.7 g

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

Appearance of the product and contents of the pack

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

Pack sizes:

1 x 493 ml, 6 x 493 ml
1 x 986 ml, 4 x 986 ml
1 x 1,477 ml, 4 x 1,477 ml
1 x 1,970 ml, 4 x 1,970 ml
1 x 2,463 ml, 3 x 2,463 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
or
Fresenius Kabi Austria GmbH, AT-8055 Graz, Austria

Date of the most recent review of this leaflet: January 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/

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This information is intended for healthcare professionals only:

Warnings and Special 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 equilibrium, and liver enzyme tests, should be monitored.

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

SmofKabiven without electrolytes central 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, electrolytes, and vitamins must be added to SmofKabiven without electrolytes central, according to the patient's individual needs.

Dosage

Adults

Dosage: A dosage range of 13–31 ml of SmofKabiven without electrolytes central/kg body weight/day provides 0.6–1.6 g of amino acids/kg body weight/day (equivalent to 0.10–0.25 g nitrogen/kg body weight/day) and 14–35 kcal/kg body weight/day of total energy (12–27 kcal/kg body weight/day of non-protein energy).

Infusion Rate

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 should not exceed 2.0 ml/kg body weight/h (corresponding to 0.25 g glucose, 0.10 g amino acids, and 0.08 g lipids/kg body weight/h). The recommended infusion period is 14–24 hours.

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 35 ml/kg body weight/day.

Paediatric population

Children (2–11 years)

Dosage:
A dose of up to 35 ml/kg body weight/day should be regularly adjusted according to the varying nutritional requirements of paediatric patients, which differ more than in adult patients.

Infusion rate:
The maximum infusion rate is 2.4 ml/kg body weight/h (corresponding to 0.12 g amino acids/kg/h, 0.30 g glucose/kg/h, and 0.09 g lipids/kg/h). At the recommended maximum infusion rate, infusion periods longer than 14 hours and 30 minutes 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 change from day to day. The maximum daily dose is 35 ml/kg body weight/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 damaged.

Use only if the amino acid and glucose solutions are clear, colorless 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 via 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 unused mixture remaining after infusion must be discarded.

Compatibility

Compatibility data are available for defined quantities with the following commercially named products: Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adult/Infant, Soluvit lyophilized, and generic electrolytes at defined concentrations. When adding electrolytes, the amounts already present in the bag must be considered to meet the patient's clinical requirements. The generated data support additions to the activated bag as summarized in the table below:

Stable compatibility range for 8 days, i.e., 6 days storage at 2–8°C followed by 48 hours at 20–25°C.

1 includes the quantities of all products.

2 Glycophos additions may 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 only. It is not a dosing guide.

For products with brand names, consult the approved summary of product characteristics before prescribing.

Compatibility data on other additives and storage times for various mixtures are available upon request.

All additions must be made aseptically.

Shelf life after mixing 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 prior to use and the storage conditions are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additives

In-use physicochemical stability has been demonstrated for the mixed three-chamber bag with additives for up to 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 standpoint, the product should be used immediately after additives are added. If not used immediately, the storage time prior to use and the storage conditions are the responsibility of the user. Storage time should normally not exceed 24 hours at 2–8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.

Instructions for use of SmofKabiven without central electrolytes

The bag

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

1. Notches on the overpouch
2. Hanger
3. Loop for hanging the bag
4. Peel seals
5. Non-functional port (used only during manufacturing)
6. Additive port
7. Infusion port
8. Oxygen absorber

1. Removal of the overpouch

• To remove the overpouch, hold it horizontally and tear at the notch towards the ports along the top 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 have opened. The vertical peel seals open due to internal liquid pressure. The peel seals may also be opened before removing the overpouch.

Note: 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 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-shaped mark (A).

Note: The membrane of the additive port is sterile.

• Hold the base of the additive port. Insert the needle and inject the 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-shaped 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 proper retention.

Note: The inner part of the infusion port is sterile.

4. Hanging the bag

• Hang the bag by the loop located beneath the hanger.