Smofkabiven

Package leaflet: Information for the user

SmofKabiven, emulsion for infusion
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What SmofKabiven is and what it is used for
2. Important information before using SmofKabiven
3. How to use SmofKabiven
4. Possible side effects
5. How to store SmofKabiven
6. Contents of the pack and other information

1. What SmofKabiven is and what it is used for

SmofKabiven is an infusion emulsion administered intravenously via infusion. The medicine comes in a plastic bag containing amino acids (components necessary for protein synthesis), glucose (carbohydrates), lipids (fats) and electrolytes (salts). SmofKabiven may be used in adult patients and children aged 2 years and older.
SmofKabiven is administered by trained medical personnel when other forms of nutrition are insufficient or not possible.

2. Important information before using SmofKabiven

Do not use SmofKabiven if the patient has:

• hypersensitivity to the active substances or to any of the other components of this medicine (listed in section 6);
• allergy to fish or egg protein;
• allergy to peanuts or soy (SmofKabiven contains soybean oil);
• excessively high levels of fats in the blood (hyperlipidemia);
• severe liver function disorders;
• blood clotting disorders;
• amino acid metabolism disorders;
• severe kidney disease without possibility of dialysis;
• acute shock;
• uncontrolled increased blood glucose (hyperglycemia);
• increased blood (serum) levels of any of the electrolytes contained in SmofKabiven;
• fluid in the lungs (acute pulmonary edema);
• excess fluid in the body (overhydration);
• untreated heart failure;
• coagulation disorders (hemophagocytic syndrome);
• unstable general condition, e.g. severe trauma, uncontrolled diabetes, acute myocardial infarction, stroke, thrombosis, metabolic acidosis (a disorder characterized by excessive amounts of acidic substances in the blood), severe infection (severe sepsis), coma, fluid deficiency (hypotonic dehydration).

SmofKabiven should not be used in children under 2 years of age.
Warnings and precautions
Before starting treatment with SmofKabiven, consult a doctor if the patient has:

• kidney disease;
• diabetes;
• pancreatitis;
• liver disease;
• hypothyroidism (thyroid disorders);
• sepsis (severe infection).

If fever, rash, swelling, breathing difficulties, chills, sweating, nausea or vomiting occur during infusion, medical personnel should be informed immediately, as these symptoms may be due to an allergic reaction or administration of too high a dose of the medicine.
The doctor may recommend regular blood tests to monitor liver function tests and other parameters.
Children and adolescents
SmofKabiven is not intended for administration to newborns or children under 2 years of age.
SmofKabiven may be administered to children aged 2 to 16/18 years.
SmofKabiven and other medicines
Inform the doctor about all medicines currently or recently used, or those planned to be used, including medicines available without prescription.
Pregnancy and breastfeeding
There are no data available on the use of SmofKabiven during pregnancy or breastfeeding.
SmofKabiven may be administered to women during pregnancy or breastfeeding only if considered necessary by the physician. SmofKabiven may be given during pregnancy and breastfeeding on medical advice.
Driving and operating machinery
Not applicable, as SmofKabiven is administered in a hospital setting.

3. How to use SmofKabiven

This medicine should always be used exactly as directed by the physician. If in doubt, consult your
doctor.
The physician will determine the individual dose according to body weight and clinical condition of the patient.
SmofKabiven is administered only by trained medical personnel.
Use of a higher than recommended dose of SmofKabiven
It is unlikely that a patient would receive too high a dose of SmofKabiven, as this medicine is
administered by trained medical personnel.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common adverse reactions (may occur in up to 1 in 10 patients):
slight increase in body temperature.
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
elevated liver enzyme levels in blood, loss of appetite, nausea, vomiting, chills, dizziness, and headache.
Rare adverse reactions (may occur in up to 1 in 1000 patients):
low or high blood pressure, breathing difficulties, rapid heartbeat (tachycardia). Hypersensitivity reactions (which may cause symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters (raised red spots), redness, headache). Feeling hot and cold. Pallor. Mild cyanosis of lips and skin (due to blood oxygen deficiency). Pain in neck, back, bones, chest, and lumbar region.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store SmofKabiven

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

6. Contents of the pack and other information

What SmofKabiven contains
The active substances in the medicinal product 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
proline 5.7
serine 3.3
taurine 0.5
threonine 2.2
tryptophan 1.0
tyrosine 0.20
valine 3.1
calcium chloride (as dihydrate) 0.28
sodium glycerophosphate (as monohydrate) 2.1
magnesium sulfate (as heptahydrate) 0.61
potassium chloride 2.3
sodium acetate (as trihydrate) 1.7
zinc sulfate (as heptahydrate) 0.0066
glucose (as monohydrate) 127
purified soybean oil 11.4
medium-chain triglycerides 11.4
purified olive oil 9.5
fish oil rich in omega-3 fatty acids 5.7

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

What SmofKabiven looks like and contents of the pack
Glucose and amino acid solutions are clear, colourless to slightly yellow, and free from particulate matter. The fat emulsion is white and homogeneous.

Pack sizes:
1 × 493 ml, 6 × 493 ml
1 × 986 ml, 4 × 986 ml
1 × 1477 ml, 4 × 1477 ml
1 × 1970 ml, 4 × 1970 ml
1 × 2463 ml, 3 × 2463 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
SE-751 74 Uppsala
Sweden

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
Fresenius Kabi AB
SE-751 74 Uppsala
Sweden

For further information, contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Information intended exclusively for healthcare professionals:

Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended limits, administration should be performed continuously and appropriately controlled, preferably using a volumetric pump.
Since the use of a central vein for infusion is associated with an increased risk of infection, strict adherence to aseptic techniques during catheter insertion and handling is recommended to prevent any infection.
Monitoring of serum glucose and electrolyte concentrations, osmolality, fluid balance and acid-base equilibrium, as well as liver enzyme tests, is recommended.
If any signs or symptoms of an anaphylactic reaction occur (such as fever, chills, rash, or dyspnea), the infusion must be stopped immediately.
SmofKabiven must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.

Route of administration
Intravenous administration, infusion into a central vein.
To ensure complete parenteral nutrition, microelements, vitamins, and if necessary, electrolytes (taking into account electrolytes already present in SmofKabiven) should be added to SmofKabiven according to the patient's individual needs.

Dosage
Adult patients
Recommended dosage
The dosage range is 13 to 31 ml of SmofKabiven/kg body weight/day, providing 0.6 to 1.6 g of amino acids/kg body weight/day (corresponding to 0.10 to 0.25 g nitrogen/kg body weight/day) and 14 to 35 kcal/kg body weight/day of total energy (12 to 27 kcal/kg body weight/day of non-protein energy).
Infusion rate
The maximum infusion rate for glucose is 0.25 g/kg body weight/hour, for amino acids 0.1 g/kg body weight/hour, and for lipids 0.15 g/kg body weight/hour.
The infusion rate should not exceed 2.0 ml/kg body weight/hour (equivalent to 0.25 g glucose, 0.10 g amino acids, and 0.08 g lipids/kg body weight/hour). The recommended duration of infusion is 14 to 24 hours.
Maximum daily dose
The maximum daily dose depends on the patient's clinical condition and may vary from day to day. The recommended maximum daily dose is 35 ml/kg body weight/day.

Children and adolescents
Children aged 2–11 years
Recommended dosage
A dose of up to 35 ml/kg body weight/day should be regularly adjusted according to the individual requirements of pediatric patients, which vary more significantly than in adults.
Infusion rate
The recommended maximum infusion rate is 2.4 ml/kg body weight/hour (equivalent to 0.12 g amino acids/kg body weight/hour, 0.30 g glucose/kg body weight/hour, and 0.09 g lipids/kg body weight/hour).
Except in special circumstances requiring close monitoring, when the recommended maximum infusion rate is used, the infusion duration should not exceed 14 hours and 30 minutes. The recommended infusion duration is 12 to 24 hours.
Maximum daily dose
The maximum daily dose varies depending on the patient's clinical condition and may change daily. The recommended maximum daily dose is 35 ml/kg body weight/day.
Adolescents aged 12–16/18 years
In adolescents, SmofKabiven may be dosed as in adult patients.

Special precautions for removal and preparation of the medicinal product for use
Do not use if the packaging is damaged.
Use only if the amino acid and glucose solutions are clear, colorless to slightly yellow, and the lipid emulsion is white and homogeneous. The contents of the three separate compartments must be mixed before use, as well as before adding any other substances through the designated port.
After removing the safeguards, the bag should be inverted several times to ensure thorough mixing of all components and to obtain a homogeneous mixture with no visible signs of phase separation.
For single use only. Any unused residue remaining after infusion must be discarded.

Compatibility
Compatibility data are available for the following medicinal products: Dipeptiven, Supliven/Addamel N, Glycophos, Addiphos, Vitalipid N Adult/Infant, and Soluvit N, in specified quantities and in electrolytes of specified concentrations.
When adding electrolytes, the amounts already present in the bag must be taken into account to meet the patient's clinical needs. Available data confirm that the above-mentioned medicinal products can be added to the activated bag according to the table below:
Compatibility range: stable for 8 days, i.e., 6 days stored at 2–8 °C, followed by 48 hours at 20–25 °C.

Warning: This table is intended to demonstrate compatibility only. It does not provide dosing guidelines.
Before prescribing the above-mentioned medicinal products, please consult the approved package leaflets.
Information regarding compatibility with other additives and storage times for various mixtures is available upon request.
All additives must be combined with the medicinal product under aseptic conditions.

Shelf life after mixing the contents of the bag
Physical and chemical stability of the mixed contents of the 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. Otherwise, the user is responsible for the in-use storage period and storage conditions prior to use. This period should not normally exceed 24 hours at 2–8°C, unless mixing was carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additional substances
Physico-chemical stability of the mixed contents of the three-chamber bag with additional substances has been demonstrated for up to 8 days: 6 days at 2–8°C followed by 48 hours at 20–25°C, including infusion duration. From a microbiological point of view, the product should be used immediately after addition of other components. Otherwise, the user is responsible for the in-use storage period and storage conditions prior to use. This period should not normally exceed 24 hours at 2–8°C, unless mixing was carried out under controlled and validated aseptic conditions.

SmofKabiven Instructions for preparing the bag for use

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

1. Perforation in the outer bag
2. Bag handle
3. Hanging hole
4. Seals separating individual chambers of the bag
5. Blind port (used only during manufacturing)
6. Port for administration of additional substances
7. Infusion port
8. Oxygen absorber

1. Removing the outer bag

• To remove the outer bag, lay it horizontally and tear along the upper edge starting from the perforation near the ports (A).
• Then tear the outer bag along the long edge, remove it, and discard it together with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, firmly roll the bag towards the ports, first with the right hand, then applying steady pressure with the left hand, until the vertical seals rupture. They open under fluid pressure. The seals may also be opened before removing the outer bag. Note: The liquid mixes easily even if the horizontal seal remains intact.

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

• Mix the contents of the three chambers by inverting the bag three times, which should ensure thorough mixing of the components.

3. Final preparation steps

• Place the bag again on a flat, level surface. Just before adding additional substances, remove the single-use cap marked with an arrow, which protects the white port for administration of additional substances (A). Note: The membrane of the port for administration of additional substances is sterile.
• Hold the base of the port for administration of additional substances. Insert the needle and inject additional substances (known to be compatible) through the center of the injection site (B).
• After each addition, thoroughly mix the contents of the bag by inverting it three times. Use syringes with needles 18 to 23 G in diameter and a maximum length of 40 mm.

• Just before connecting the infusion set, remove the single-use cap protecting the blue infusion port (A). Note: The membrane of the infusion port is sterile.
• Use infusion sets without an air vent or close the air vent if present.
• Hold the base of the infusion port.
• Insert the spike of the infusion set into the infusion port. To ensure secure fixation, insert the entire length of the spike. Note: The inner surface of the infusion port is sterile.

4. Hanging the bag

• Suspend the bag using the hole located below the handle.