Smofkabiven Electrolyte free Central emulsion for infusion – patient leaflet, side effects, dosage

1. What SmofKabiven Electrolyte Free Central is and what it is used for

SmofKabiven Electrolyte Free Central is an emulsion for infusion given into your blood by a drip (intravenous infusion). The product contains amino acids (components used to build proteins), glucose (carbohydrates) and lipids (fat) in a plastic bag and can be given to adults and children aged 2 years and above.

A healthcare professional will give you SmofKabiven Electrolyte Free Central when other forms of feeding are not good enough or have not worked.

2. What you need to know before you use SmofKabiven Electrolyte Free Central

if you are allergic (hypersensitive) to active substances or any of the other ingredients of this medicine (listed in section 6)

• if you are allergic to fish or egg
• if you are allergic to peanuts or soya you should not use this product. SmofKabiven Electrolyte Free Central contains soybean oil
• if you have too much lipids in the blood (hyperlipidaemia)
• if you have serious liver disorder
• if you have blood clotting problems (coagulation disorders)
• if your body has problems using amino acids
• if you have serious kidney disease without access to dialysis
• if you are in acute shock
• if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled
• if you have fluid in the lungs (acute pulmonary oedema)
• if you have too much body fluid (hyperhydration)

• if you have heart failure that is not treated

  The following information is intended for healthcare professionals only:

  Warnings and precautions for use

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

  Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination especially during catheter insertion and manipulations.

  Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver and enzyme tests should be monitored.

  Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

  SmofKabiven Electrolyte Free Central should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

  Method of administration

  Intravenous use, infusion into a central vein.

  To provide total parenteral nutrition, trace elements, electrolytes and vitamins should be added to SmofKabiven Electrolyte Free Central according to the patients need.

  Posology

  Adults

  Dosage:

  The dosage range of 13-31 ml SmofKabiven Electrolyte Free/kg bw/day will provide 0.6-1.6 g amino acids/kg bw/day (corresponds to 0.10-0.25 g nitrogen/kg bw/day) and 14-35 kcal/kg bw/day of total energy (12-27 kcal/kg bw/day of non-protein energy).

  Infusion rate

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

  The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.25 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h). The recommended infusion period is 14-24 hours.

  Maximum daily dose:

  The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 35 ml/kg bw/day.

  Paediatric population

  Children (2-11 years)

  Dosage:

  The dose up to 35 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.

  Infusion rate:

  The recommended maximum infusion rate is 2.4 ml/kg bw/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, do not use an infusion period longer than 14 hours 30 minutes, except in exceptional cases and with careful monitoring. The recommended infusion period is 12-24 hours.

  Maximum daily dose:

  The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 35 ml/kg bw/day.

  Adolescents (12-16/18 years)

  In adolescents, SmofKabiven Electrolyte Free can be used as in adults.

  Precautions for disposal

  Do not use if package is damaged. Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.

  After separation of the peelable seals the bag should be inverted on a number of occasions to ensure a homogenous mixture, which does not show any evidence of phase separation.

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

  Compatibility

  Compatibility data are available with the named branded products Dipeptiven, Addamel N/Addaven, Glycophos, Addiphos, Vitalipid N Adult/Infant and Soluvit N in defined amounts and generics of electrolytes in defined concentrations. When making electrolyte additions, the amounts already present in the bag should be taken into account to meet the clinical needs of the patient. Generated data supports additions to the activated bag according to the summary table below:

  Compatibility range stable for 8 days, i.e., 6 days storage at 2-8°C followed by 48 hours at 20-25°C

  340 047

  • if you have a defect in your blood clotting system (haemophagocytotic syndrome)
  • if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot (embolism), metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don’t have enough body fluid (hypotonic dehydration).
  • In children under 2 years of age

Warnings and precautions

Talk to your doctor before using SmofKabiven Electrolyte Free Central if you have:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothrodism (thyroid problems)
• sepsis (serious infection)

If during the infusion you get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the healthcare professional immediately because these symptoms might be caused by an allergic reaction or that you have been given too much of the medicine.

Your doctor may regularly need to check your blood for liver function tests and other values.

Children and adolescent

SmofKabiven Electrolyte Free Central is not meant for newborn babies or children younger than 2 years old. SmofKabiven Electrolyte Free can be given to children from 2 to 16/18 years old.

Other medicines and SmofKabiven Electrolyte Free Central Tell your doctor if you are taking, have recently taken or might take any other medicines, even without prescription.

Pregnancy and breast-feeding

Data from using SmofKabiven Electrolyte Free Central during pregnancy or breast-feeding is lacking. SmofKabiven Electrolyte Free Central should therefore be given to pregnant or breast-feeding women only if the doctor find it necessary. The use of SmofKabiven Electrolyte Free Central may be considered during pregnancy and breastfeeding, as advised by your doctor

Driving and using machines

Not relevant as the medicine is given at the hospital.

3. How to use SmofKabiven Electrolyte Free Central

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven Electrolyte Free Central will be given to you by a healthcare professional. If you use more SmofKabiven Electrolyte Free Central than you should

V005/UP

¹ includes amounts from all products.

² Glycophos additions may be doubled with a stability of 7 days, i.e., 6 days 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 dosing guideline.

For branded products, before prescribing refer to national approved prescribing information.

• Compatibility with further additives and the storage time of different admixtures will be available upon request.

Additions should be made aseptically.

Shelf-life after mixing the chambers of the bag Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 48 hours at 20-25°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.

Shelf-life after mixing with additives

Physico-chemical in-use stability of the mixed three chamber bag with additives has been demonstrated for up to 8 days, i.e., 6 days at 2-8°C followed by 48 hours at 20-25°C, including duration of administration. From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user. The storage time should normally not be longer than 24 hours at 2-8°C, unless addition of supplements has taken place in controlled and validated aseptic conditions.

340 047 V005/UP

1. 2. Mixing
2. • Place the bag on a flat surface.
3. • Roll up the bag tightly from the handle side towards the ports, firstly with the right hand and then applying a constant pressure with the left hand until the vertical seals are broken. The vertical peel seals open due to the pressure of the fluid. The peel seals can also be opened before removing the overpouch.

Please note: The liquids mix easily although the horizontal seal remains closed.

• Mix the contents of the three chambers by inverting the bag three times until the components are thoroughly mixed.
• Finalising the preparation:
• Place the bag on a flat surface again. Shortly before injecting the additives, break off the tamper-evident arrow flag from the white additive port (A). Please note: The membrane in the additive port is sterile.
• Hold the base of the additive port. Insert the needle, inject the additives (with known compatibility) through the centre of the injection site (B).

• Mix thoroughly between each addition by inverting the bag three times. Use syringes with needles of 18-23 gauge and a length of max. 40 mm.

  • Hang the bag up by the hole below the handle.
  • Shortly before inserting the infusion set, break off the tamper evident arrow flag from the blue infusion port (A).

Please note: The membrane in the infusion port is sterile.

• Use a non-vented infusion set or close the air-inlet on a vented set.
• Hold the base of the infusion port.
• Push the spike through the infusion port. The spike should be fully inserted to secure it in place. Please note: The inner part of the infusion port is sterile.

• Hanging up the bag

  Proline 5.7 Serine 3.3 Taurine 0.5 Threonine 2.2 Tryptophan 1.0 Tyrosine 0.20 Valine 3.1 Glucose (as monohydrate) 127 Soybean oil, refined 11.4 Medium-chain triglycerides 11.4 Olive oil, refined 9.5 Fish oil, rich in omega-3-fatty acids 5.7 The other ingredients are: glycerol, purified egg phospholipids, all-rac-a-tocopherol, sodium hydroxide (pH adjustment), sodium oleate, glacial acetic acid (pH adjustment), hydrochloric acid (pH adjustment) and water for injections.

  What SmofKabiven Electrolyte Free Central looks like and contents of the pack

  Glucose and amino acid solutions are clear and colourless or slightly yellow and free from particles. The lipid emulsion is white and homogenous.

  Pack 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 Authorisation Holder and Manufacturer

  Manufacturer:

  Fresenius Kabi AB, SE-751 74 Uppsala, Sweden

  Fresenius Kabi Austria GmbH, AT-8055 Graz, Austria

  Marketing authorisation holder:

  MAH for IE:

  Fresenius Kabi Deutschland GmbH

  Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany

  MAH for UK:

  Fresenius Kabi Ltd

  Cestrian Court Eastgate Way Manor Park

  Runcorn Cheshire WA7 1NT

  United Kingdom

  This leaflet was last revised in January 2023.

Instructions for use The bag

• Notches in the overpouch
• Handle
• Hole for hanging the bag
• Peelable seals
• Blind port (only used during manufacturing)
• Additive port
• Infusion port
• Oxygen absorber
• To remove overpouch, hold the bag horizontally and tear from the notch close to the ports along the upper edge (A).
• Then simply tear the long side, pull off the overpouch and discard it along with the oxygen absorber (B).

• Removal of overpouch

  It is unlikely that you will receive too much medicine as SmofKabiven Electrolyte Free Central is given to you by a healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people): a slightly raised body temperature.

Uncommon (may affect up to 1 in 100 people): high blood (plasma) levels of compounds from the liver, lack of appetite, nausea, vomiting, chills, dizziness and headache.

Rare (may affect up to 1 in 1,000 people): low or high blood pressure, difficulty in breathing, fast heart beat (tachycardia). Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised red areas), flushing, headache). Sensations of hot and cold. Paleness. Light blue coloured lips and skin (because of too less oxygen in the blood). Pain in the neck, back, bones, chest and loins.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

UK

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance Website: www.hpra.ie

5. How to store SmofKabiven Electrolyte Free Central

Keep this medicine out of the sight and reach of children. Store in overpouch. Do not store above 25°C. Do not freeze. Do not use this medicine after the expiry date which is stated on the label on the bag and box. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What SmofKabiven Electrolyte Free Central contains

The active substances are g per 1000 ml

Alanine 7.1 Arginine 6.1 Glycine 5.6 Histidine 1.5 Isoleucine 2.5 Leucine 3.8 Lysine (as acetate) 3.4 Methionine 2.2 Phenylalanine 2.6