Smofkabiven nutribase

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What SmofKabiven Nutribase is and what it is used for

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

2. Important information before using SmofKabiven Nutribase

Do not use SmofKabiven Nutribase if the patient has:

• hypersensitivity to the active substances or any of the other ingredients of this medicine (listed in section 6);
• allergy to fish or egg protein;
• allergy to peanuts or soy (SmofKabiven Nutribase contains soy oil);
• excessively high levels of fats in the blood (hyperlipidemia);
• severe liver function disorders;
• severe coagulation disorders (severe blood clotting problems);
• inherited amino acid metabolism disorder;
• severe kidney disease without possibility of dialysis or hemofiltration;
• acute shock (severe circulatory disturbances);
• uncontrolled high blood glucose levels (hyperglycemia);
• increased blood (serum) concentration of any of the electrolytes contained in SmofKabiven Nutribase;
• fluid in the lungs (acute pulmonary edema);
• excess fluid in the body (overhydration);
• untreated heart failure;
• coagulation disorder (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 Nutribase should not be used in newborns and children under 2 years of age.
Warnings and precautions
Before starting treatment, discuss with the 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 must be informed immediately, as these symptoms may be caused by 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 Nutribase is not intended for administration to newborns or children under 2 years of age. SmofKabiven Nutribase may be administered to children and adolescents aged 2 to 18 years.
SmofKabiven Nutribase and other medicines
Inform the doctor about all medicines currently used or recently used by the patient, as well as any medicines the patient plans to use, including those available without prescription.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
There are no data available on the use of SmofKabiven Nutribase during pregnancy. SmofKabiven Nutribase should be administered to pregnant women only if considered necessary by the physician. SmofKabiven Nutribase may be given during pregnancy under medical supervision.
There are no available data on the use of SmofKabiven Nutribase in breastfeeding women. Components and metabolites of parenteral nutrition, such as SmofKabiven Nutribase, pass into human milk. Parenteral nutrition may be necessary during breastfeeding. SmofKabiven Nutribase may be administered to breastfeeding women only after careful consideration by the physician of the potential risks and benefits.
Driving and operating machinery
Not applicable, as SmofKabiven Nutribase is administered in a hospital setting.

3. How to use SmofKabiven Nutribase

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the
doctor.
The doctor will determine the individual dose according to body weight and clinical condition of the patient. SmofKabiven
Nutribase is administered by trained medical personnel.
Use of a higher than recommended dose of SmofKabiven Nutribase
It is unlikely that a patient would receive too high a dose of SmofKabiven Nutribase, since
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):
High levels of liver enzymes in the 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 present symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters (raised red areas), redness, headache). Sensation of heat and cold. Pallor. Mild cyanosis of lips and skin (related to blood oxygen deficiency). Pain in the 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 may 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 Nutribase

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze. Store in the outer bag.
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 Nutribase contains
The active substances in the medicine are: g per 1000 ml

Other ingredients (excipients) are: glycerol, purified egg phospholipids,
all- rac -α-tocopherol, sodium hydroxide (for pH adjustment), sodium oleate, glacial acetic acid
(for pH adjustment) and water for injections.
What SmofKabiven Nutribase looks like and contents of the pack
SmofKabiven Nutribase, emulsion for infusion, is available in triple-chamber bags, in which one
chamber contains glucose solution, the second contains amino acids, and the third contains the fat emulsion. The glucose and amino acid solutions are clear, colourless to slightly yellow, free from solid particles. The fat emulsion is white and homogeneous.
Pack sizes:
1 x 1026 ml, 4 x 1026 ml
1 x 1539 ml, 4 x 1539 ml
1 x 2052 ml, 4 x 2052 ml
1 x 2565 ml, 3 x 2565 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi AB
Rapsgatan 7
751 74 Uppsala
Sweden
For further information, please 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
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Austria pending
Belgium SmofKabiven Nutribase emulsie voor infusie
SmofKabiven Nutribase émulsion pour perfusion
SmofKabiven Nutribase Emulsion zur Infusion
Bulgaria СмофКабивен Централ Нутрибейз инфузионна емулсия
Croatia SmofKabiven Nutribase emulzija za infuziju
Cyprus SmofKabiven Nutribase
Denmark SmofKabiven Nutribase
Estonia SmofKabiven Nutribase
Finland SmofKabiven Nutribase
France SmofKabiven Nutribase émulsion pour perfusion
Greece pending
Spain SmofKabiven Nutribase emulsión para perfusión
Netherlands SmofKabiven Nutribase emulsie voor infusie
Ireland SmofKabiven Nutribase
Iceland SmofKabiven Nutribase innrennslislyf, fleyti
Lithuania pending
Luxembourg pending
Latvia SmofKabiven Nutribase emulsija infūzijām
Germany pending
Norway SmofKabiven Nutribase infusjonsvæske, emulsjon
Poland SmofKabiven Nutribase
Portugal SmofKabiven Nutribase
Czech Republic SmofKabiven Nutribase
Romania SmofKabiven Nutribase emulsie perfuzabilă
Slovakia SmofKabiven Nutribase
Slovenia SmofKabiven Nutribase emulzija za infundiranje
Sweden SmofKabiven Nutribase
Hungary SmofKabiven Nutribase emulziós infúzió
United Kingdom SmofKabiven Nutribase

Information intended exclusively for medical professionals (for further information, please refer to the Summary of Product Characteristics).
Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended rate, continuous and appropriately controlled infusion is recommended, 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, osmolarity, fluid balance and acid-base equilibrium, as well as liver enzyme tests, is recommended.
If any signs or symptoms of an anaphylactic reaction (such as fever, chills, rash or dyspnoea) occur, the infusion must be stopped immediately.
SmofKabiven Nutribase must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
Method of administration
Intravenous administration, infusion into a central vein.
To ensure complete parenteral nutrition, microelements, vitamins and, if necessary, electrolytes (taking into account the electrolytes already present in SmofKabiven Nutribase) should be added to SmofKabiven Nutribase according to the patient's needs. Mixing components within the SmofKabiven Nutribase bag should only be performed if compatibility has been demonstrated; see section: Special precautions for disposal and preparation for use.
Dosage
Adult patients
Recommended dosage
The dosage range is 18 to 40 ml of SmofKabiven Nutribase per kg body weight per day, providing 0.10 to 0.22 g nitrogen/kg body weight/day (0.6 to 1.4 g amino acids/kg body weight/day) and 16 to 35 kcal/kg body weight/day total energy (13 to 30 kcal/kg body weight/day non-protein energy).
Infusion rate
The maximum infusion rate is 0.25 g glucose/kg body weight/hour, 0.1 g amino acids/kg body weight/hour, and 0.15 g fat/kg body weight/hour.
The infusion rate should not exceed 2.8 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acids and 0.11 g fat per kg body weight per hour).
The recommended duration of infusion is 6.5 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 40 ml/kg body weight/day.
Children and adolescents
Children aged 2 to 11 years
Recommended dosage
The dose of up to 40 ml/kg body weight/day should be regularly adjusted to meet the requirements of paediatric patients, which vary more significantly than in adult patients.
Infusion rate
The infusion rate should not exceed 3.4 ml/kg body weight/hour (corresponding to 0.30 g glucose, 0.12 g amino acids and 0.13 g fat per kg body weight per hour).
The recommended duration of infusion is 5 to 24 hours. Except in special circumstances and with careful monitoring, when the recommended maximum infusion rate is used, the infusion duration should not exceed 11 hours and 45 minutes.
Maximum daily dose
The maximum daily dose varies depending on the patient's clinical condition and may change from day to day. The maximum recommended daily dose is 40 ml/kg body weight/day.
Adolescents aged 12 to 18 years
In adolescents, SmofKabiven Nutribase may be dosed as in adult patients.
Special precautions for disposal and preparation for use
Do not use if the packaging is damaged.
Use only if the amino acid and glucose solutions are clear, colourless to slightly yellow, and the fat emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use, as well as before adding any other substances through the designated port.
After removing the safety seals, the bag should be inverted three times to thoroughly mix all components and obtain a homogeneous mixture without visible signs of phase separation.
For single use only. Any unused portions of the medicinal product remaining after infusion must be discarded.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.
Compatibility
The following compatibility table shows the possibilities of adding the medicinal products Dipeptiven, Supliven, Vitalipid N Adult/Infant and Soluvit N (lyophilisate). Available data confirm that the above-mentioned medicinal products can be added to the activated bag according to the table below:

Warning: This table is intended to show compatibility only. It does not provide dosing guidelines.
All additives must be combined with the medicinal product under aseptic conditions.

Stability after mixing
Physical and chemical stability of the mixed contents of the triple-chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view, the medicinal product should be used immediately. Otherwise, the user is responsible for the in-use storage duration and storage conditions prior to use. This period should not normally exceed 24 hours at 2–8°C.

Stability after mixing with additional substances
From a microbiological point of view, the medicinal product should be used immediately after addition of other components.

SmofKabiven Nutribase Instructions for preparing the bag for use

1. Cut in the outer bag
2. Bag handle
3. Hanger 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. Removal of the outer bag

• To remove the outer bag, lay it flat and starting from the cut near the ports, tear along the upper edge (A).
• Then tear the outer bag along the long edge, remove it and dispose of 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. The seals open under fluid pressure. The seals may also be opened before removing the outer bag. Note: The liquid mixes easily even though the horizontal seal remains intact.

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

3. Final preparation steps

• Place the bag again on a flat, level surface. Immediately 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 (with known compatibility) through the center of the injection site (B).
• After each addition, mix the contents of the bag thoroughly by inverting the bag three times. Use syringes with needles sized 18 to 23 G and a maximum length of 40 mm.

• Immediately 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 infusion set spike into the infusion port. To ensure secure attachment, insert the full length of the spike. Note: The inner surface of the infusion port is sterile.

4. Hanging the bag

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