Smofkabiven extra nitrogen

Package leaflet: Information for the user

SmofKabiven extra Nitrogen, emulsion for infusion
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

1. What SmofKabiven extra Nitrogen is and what it is used for

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

2. Important information before using SmofKabiven extra Nitrogen

Do not use SmofKabiven extra Nitrogen 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 soy (SmofKabiven extra Nitrogen contains soybean oil);
• excessively high levels of fats in the blood (hyperlipidemia);
• severe liver function disorders;
• blood clotting problems (coagulation disorders);
• amino acid metabolism disorders;
• severe kidney disease without possibility of dialysis;
• acute shock;
• uncontrolled increased blood glucose levels (hyperglycemia);
• increased blood (serum) levels of any of the electrolytes contained in SmofKabiven extra Nitrogen;
• fluid in the lungs (acute pulmonary edema);
• excess fluid in the body (overhydration);
• untreated heart failure;
• coagulation system disorder (hemophagocytic syndrome);
• unstable clinical 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 extra Nitrogen should not be used in newborns and children under 2 years of age.
Warnings and precautions
Before starting treatment with SmofKabiven extra Nitrogen, 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 must 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 and other parameters.
Children and adolescents
SmofKabiven extra Nitrogen is not intended for use in newborns or children under 2 years of age. SmofKabiven extra Nitrogen may be administered to children and adolescents aged 2 to 16/18 years.
SmofKabiven extra Nitrogen and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those available without prescription.
Pregnancy and breastfeeding
There are no data on the use of SmofKabiven extra Nitrogen during pregnancy or breastfeeding. SmofKabiven extra Nitrogen may be administered to women during pregnancy or breastfeeding only if considered necessary by the physician. SmofKabiven extra Nitrogen may be administered during pregnancy and breastfeeding under medical supervision.
Driving and operating machinery
Not applicable, as this medicine is administered in a hospital setting.

3. How to use SmofKabiven extra Nitrogen

This medicine should always be used 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 extra Nitrogen is administered only by trained medical personnel.
Use of a higher than recommended dose of SmofKabiven extra Nitrogen
It is unlikely that a patient would receive an excessive dose of SmofKabiven extra Nitrogen,
since this medicine is administered by trained medical personnel.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Common adverse reactions (may occur in not more than 1 in 10 patients): slight increase in body temperature.
Uncommon adverse reactions (may occur in not more than 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 not more than 1 in 1000 patients): low or high blood pressure, breathing difficulties, increased heart rate (tachycardia). Hypersensitivity reactions (which may present symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters (elevated red areas), redness, headache). Sensation of heat and cold. Pallor. Mild cyanosis of lips and skin (related to blood hypoxia). Pain in neck, back, bones, chest, and lumbar region.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 the medicine.

5. How to store SmofKabiven extra Nitrogen

Keep this medicine out of the 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 package and other information

What SmofKabiven extra Nitrogen contains
The active substances are:
g per 1000 ml
alanine 9.2
arginine 7.9
glycine 7.2
histidine 2.0
isoleucine 3.3
leucine 4.8
lysine (as acetate) 4.3
methionine 2.8
phenylalanine 3.3
proline 7.3
serine 4.3
taurine 0.65
threonine 2.9
tryptophan 1.3
tyrosine 0.26
valine 4.1
calcium chloride (as dihydrate) 0.28
sodium glycerophosphate (as 0.61
monohydrate)
magnesium sulfate (as heptahydrate) 2.3
potassium chloride 2.3
sodium acetate (as trihydrate) 1.6
zinc sulfate (as heptahydrate) 0.0066
glucose (as monohydrate)
refined soybean oil 8.7
medium-chain triglycerides 8.7
refined olive oil 7.2
fish oil enriched with omega-3 fatty acids 4.3

The other ingredients (excipients) are: glycerol, purified egg yolk 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 extra Nitrogen looks like and contents of the pack
Glucose and amino acid solutions are clear, colourless to slightly yellowish, and free from solid particles.
The fat emulsion is white and homogeneous.

Pack sizes:
1 × 506 ml, 6 × 506 ml
1 × 1012 ml, 4 × 1012 ml
1 × 1518 ml, 4 × 1518 ml
1 × 2025 ml, 4 × 2025 ml
1 × 2531 ml, 3 × 2531 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

Information intended exclusively for medical professionals:

Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended speed, continuous and appropriately controlled administration is recommended, preferably using a volumetric pump.
Since the use of a central vein for infusion carries an increased risk of infection, strict adherence to aseptic procedures during catheter insertion and handling is advised 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 occur (such as fever, chills, rash, or dyspnea), the infusion must be stopped immediately.
SmofKabiven extra Nitrogen 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 electrolytes already present in SmofKabiven extra Nitrogen) should be added to SmofKabiven extra Nitrogen according to the patient's individual needs.

Dosage
Adult patients
Recommended dosage
The dosage range is 13 to 31 ml of SmofKabiven extra Nitrogen/kg body weight/day, providing 0.14 to 0.32 g nitrogen/kg body weight/day (0.85 to 2.0 g amino acids/kg body weight/day) and 12 to 28 kcal/kg body weight/day total energy (8 to 19 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 lipids/kg body weight/hour.
The infusion rate should not exceed 1.5 ml/kg body weight/hour (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 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 even from day to day. The recommended maximum daily dose is 31 ml/kg body weight/day.

Children and adolescents
Children aged 2–11 years
Recommended dosage
The dose of up to 31 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 1.8 ml/kg body weight/hour (corresponding to 0.12 g amino acids/kg body weight/hour, 0.15 g glucose/kg body weight/hour, and 0.05 g lipids/kg body weight/hour).
Except in special circumstances requiring careful monitoring, when the recommended maximum infusion rate is used, the infusion duration should not exceed 17 hours. 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 31 ml/kg body weight/day.

Adolescents aged 12–16/18 years
In adolescents, SmofKabiven extra Nitrogen can be dosed as in adults.

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 should be mixed before use, as well as before adding any other substances via the designated port.
After removing the protective covers, the bag should be inverted several times to ensure thorough mixing of all components and to obtain a homogeneous mixture without visible signs of phase separation.
For single use only. Any unused remnants of the medicinal product remaining after infusion must be discarded.

Compatibility
Compatibility data are available for Dipeptiven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant, and Soluvit N, in specified quantities and with electrolytes at specified concentrations. When adding electrolytes, the amounts already present in the bag must be taken into account to meet the patient's clinical requirements. Available data confirm the possibility of adding the above-mentioned medicinal products to the activated bag according to the table below:
Compatibility range: stable for 7 days, i.e., 6 days stored at 2–8 °C, followed by 24 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 drugs, please consult the approved package inserts.
Information regarding compatibility with other additives and storage times of various mixtures is available upon request.
All additives must be combined with the product under aseptic conditions.

Shelf life after mixing the contents of the bag compartments
Physical and chemical stability of the mixed contents of the three-compartment bag has been demonstrated for 48 hours at a temperature of 20–25 °C. From a microbiological standpoint, the 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 generally exceed 24 hours at 2–8 °C unless mixing was performed under controlled and validated aseptic conditions.

Shelf life after mixing with additional substances
Physicochemical stability of the mixed contents of the three-compartment bag with additional substances has been demonstrated for up to 7 days: 6 days at 2–8 °C followed by 24 hours at 20–25 °C, including infusion duration. From a microbiological standpoint, the product should be used immediately after addition of other components. Otherwise, the user is responsible for the in-use storage duration and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8 °C unless mixing was performed under controlled and validated aseptic conditions.

SmofKabiven extra Nitrogen Instructions for preparing the bag for use

1. Cut in the outer bag
2. Bag handle
3. Bag hanging hole
4. Seals separating individual bag compartments
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 flat horizontally and, starting from the cut 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 toward the ports, first using the right hand, then applying steady pressure with the left hand until the vertical seals rupture. These seals open under fluid pressure. The seals may also be opened before removing the outer bag. Note: mixing occurs easily even if the horizontal seal remains intact.

• Mix the contents of the three compartments thoroughly by inverting the bag three times, which should ensure adequate mixing of 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 additive port (A). Note: the membrane of the additive port is sterile.
• Hold the base of the additive port. Insert the needle and inject the additional substances (with known compatibility) into the center of the injection site (B).
• After each addition, mix the bag contents thoroughly by inverting the bag 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 infusion set spike fully into the infusion port to ensure secure attachment. Note: the inner surface of the infusion port is sterile.

4. Hanging the bag

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