Smofkabiven efg

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• 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.

Contents of the leaflet

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

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

SmofKabiven EF is an infusion emulsion administered to the patient via intravenous infusion (IV infusion). The medicine comes in a plastic bag containing amino acids (components necessary for protein formation), glucose (carbohydrates), and fats (lipids). The medicine may be used in adult patients and children aged 2 years and above.
SmofKabiven EF is administered by trained medical personnel when other methods of nutrition are insufficient or not possible.

2. Important information before using SmofKabiven EF

Do not use SmofKabiven EF if the patient has:

• hypersensitivity to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• allergy to fish or egg protein;
• allergy to peanuts or soya (SmofKabiven EF contains soybean oil);
• excessively high levels of fats in the blood (hyperlipidemia);
• severe liver dysfunction;
• blood clotting disorders;
• amino acid metabolism disorders;
• severe kidney disease without possibility of dialysis;
• acute shock;
• uncontrolled elevated blood glucose levels (hyperglycemia);
• fluid in the lungs (acute pulmonary edema);
• excess fluid in the body (overhydration);
• untreated heart failure;
• coagulation system 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 EF should not be used in children under 2 years of age.
Warnings and precautions
Before starting treatment with SmofKabiven EF, discuss with 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 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 EF is not intended for administration to neonates or children under 2 years of age.
SmofKabiven EF may be administered to children aged 2 to 16/18 years.
SmofKabiven EF and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
There are no data available on the use of SmofKabiven EF during pregnancy or breastfeeding.
SmofKabiven EF may be administered to pregnant or breastfeeding women only if considered necessary by the doctor. SmofKabiven EF may be given during pregnancy and breastfeeding on the advice of a doctor.
Driving and operating machinery
Not applicable, as SmofKabiven EF is administered in a hospital setting.

3. How to use SmofKabiven EF

This medicine should always be used as directed by the physician. If in doubt, consult the
physician.
The physician determines the individual dose according to body weight and clinical condition of the patient. SmofKabiven
EF is administered only by trained medical personnel.
Administration of a higher than recommended dose of SmofKabiven EF
It is unlikely that a patient would receive an excessive dose of SmofKabiven EF, 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):
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). Feeling hot or cold. Pallor. Mild cyanosis of lips and skin (related to blood oxygen deficiency). Pain in the neck, back, bones, chest and lower back.

Reporting of adverse reactions
If any adverse reactions occur, including any 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
Tel: +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 this medicine.

5. How to store SmofKabiven EF

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 the cardboard box.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What SmofKabiven EF 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
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
refined soybean oil 11.4
medium-chain triglycerides 11.4
refined olive oil 9.5
fish oil rich in omega-3 fatty acids 5.7

The 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 EF 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 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 medical professionals:

Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended rate, continuous and appropriately controlled administration 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 procedures 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 performance of 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 EF 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, electrolytes and vitamins should be added to SmofKabiven EF according to the individual patient's needs.

Dosage
Adult patients
Recommended dosage
The dosage range is 13 to 31 ml of SmofKabiven EF/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 dosage 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 situations requiring careful 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 from day to day. The recommended maximum daily dose is 35 ml/kg body weight/day.
Adolescents aged 12–16/18 years
In adolescents, SmofKabiven EF can be dosed as in adult patients.

Special precautions for disposal and preparation of the medicinal product for administration
Do not use if the packaging is damaged.
Use only when 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 via the designated port.
After removing the protective seals, 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 portions 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, their existing amounts already present in the bag must be taken into account to meet the patient's clinical requirements. 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.

Note: This table is intended to demonstrate compatibility. It does not constitute dosing guidelines.
Before prescribing the above-mentioned drugs, please consult the approved package inserts.
Information regarding compatibility with other additives and storage times for various mixtures is
available upon request.
All additives must be combined with the drug under aseptic conditions.

Shelf life after mixing the contents of the bag chambers
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 standpoint, the product should be used immediately. Otherwise, responsibility for the storage duration during use and storage conditions prior to administration lies with the user. This period should not generally 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
Physicochemical 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 standpoint, the product should be used immediately after addition of other components. Otherwise, responsibility for the storage duration during use and storage conditions prior to administration lies with the user. This period should not generally exceed 24 hours at 2–8 °C, unless mixing was carried out under controlled and validated aseptic conditions.

SmofKabiven EF – Instructions for preparing the bag for use
Bag
493 ml, 986 ml, 1477 ml, 1970 ml, 2463 ml

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

1. Removal of the external pouch

• To remove the outer bag, lay it flat and, starting from the slit near the ports, tear along the top edge (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 continuously pressing with the left hand, until the vertical seals break. 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.

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

• Mix the contents of the three compartments by turning the bag over three times, which should ensure thorough mixing of the components.

3. Final preparation procedures

• Place the bag back on a flat, even surface. Just before administration of additional substances, remove the single-use closure cap marked with an arrow, protecting 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 the additional substances (with known compatibility) through the center of the injection site (B).
• After adding each component, mix the contents of the bag thoroughly by rotating the bag three times. Use syringes with needles of 18 to 23 G diameter and a maximum length of 40 mm.

• Just before connecting the infusion set, remove the single-use closure 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 proper securement of the spike, 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.