Smofkabiven extra Nitrogen Ef

Leaflet accompanying the packaging: information for the user

SmofKabiven extra Nitrogen EF, emulsion for infusion

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

SmofKabiven extra Nitrogen EF is an emulsion for infusion, administered to the patient through a drip (intravenous infusion). The packaging of the medicine is a plastic bag that contains amino acids (essential components for creating proteins), glucose (carbohydrates) and fats (lipids). The medicine can be used in adult patients and children aged 2 years and above.
Medical professionals administer SmofKabiven extra Nitrogen EF when other methods of nutrition are insufficient or impossible.

2. Important information before using SmofKabiven extra Nitrogen EF

Do not use SmofKabiven extra Nitrogen EF if the patient has:

• allergy to active substances or any of the other ingredients of this medicine (listed in section 6);
• allergy to fish protein or egg;
• allergy to peanuts or soy (SmofKabiven extra Nitrogen EF contains soybean oil);
• too high a level of fats in the blood (hyperlipidemia);
• severe liver function disorders;
• blood clotting problems (coagulation disorders);
• amino acid metabolism disorder;
• severe kidney disease, without the possibility of dialysis;
• acute shock;
• uncontrolled, increased blood glucose levels (hyperglycemia);
• fluid in the lungs (acute pulmonary edema);
• too much fluid in the body (overhydration);
• untreated heart failure;
• hemophagocytic syndrome (a disorder of the blood clotting system);
• unstable general condition, e.g. severe post-traumatic condition, uncontrolled diabetes, acute myocardial infarction, stroke, thrombosis, metabolic acidosis (a disorder characterized by too much acidic substance in the blood), severe infection (severe sepsis), coma, fluid deficiency (hypotonic dehydration).

Do not use SmofKabiven extra Nitrogen EF in newborns and children under 2 years of age.

Warnings and precautions

Before starting treatment with SmofKabiven extra Nitrogen EF, discuss with your doctor if the patient has:

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

If during infusion the patient experiences fever, rash, swelling, difficulty breathing, chills, sweating, nausea or vomiting, they should immediately inform the medical staff, as these symptoms may be caused by an allergic reaction or too high a dose of the medicine.
The doctor may recommend regular blood tests to determine liver function tests and other values.

Children and adolescents

SmofKabiven extra Nitrogen EF is not intended for administration to newborns or children under 2 years of age. SmofKabiven extra Nitrogen EF can be administered to children aged 2 to 16/18 years.

SmofKabiven extra Nitrogen EF and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Pregnancy and breastfeeding

There is no data on the use of SmofKabiven extra Nitrogen EF during pregnancy or breastfeeding. SmofKabiven extra Nitrogen EF is administered to pregnant or breastfeeding women only if the doctor considers it necessary. SmofKabiven extra Nitrogen EF during pregnancy and breastfeeding may be administered on the doctor's instructions.

Driving and using machines

This does not apply, as the medicine is used in a hospital.

3. How to use SmofKabiven extra Nitrogen EF

This medicine should always be used as directed by the doctor. In case of doubts, please consult a doctor.
The doctor selects an individual dose depending on the patient's body weight and clinical condition. SmofKabiven extra Nitrogen EF is administered only by medical professionals.

Using a higher dose of SmofKabiven extra Nitrogen EF than recommended

It is unlikely that the patient will receive too high a dose of SmofKabiven extra Nitrogen EF, as the medicine is administered by medical professionals.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may occur in up to 1 in 10 patients):
mild increase in body temperature.
Uncommon side effects(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 side effects(may occur in up to 1 in 1000 patients): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia).
Hypersensitivity reactions (which may cause symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters, redness, headache). Feeling of heat and cold. Paleness. Slight cyanosis of the lips and skin (related to hypoxia). Pain in the neck, back, bones, chest and lumbar region.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SmofKabiven extra Nitrogen EF

The medicine should be stored 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 the carton.
The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What SmofKabiven extra Nitrogen EF contains

The active substances of the medicine are:
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
glucose (in the form of a monohydrate compound)
85
purified soybean oil
8.7
triglycerides of saturated fatty acids with medium chain length
8.7
purified olive oil
7.2
fish oil rich in omega-3 fatty acids
4.3
The other ingredients (excipients) are: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (to adjust pH), sodium oleate, glacial acetic acid (to adjust pH), hydrochloric acid (to adjust pH) and water for injections.

What SmofKabiven extra Nitrogen EF looks like and what the pack contains

The glucose and amino acid solutions are clear, colorless to slightly yellow, particle-free. 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 authorization holder and manufacturer

Fresenius Kabi AB
Rapsgatan 7
751 74 Uppsala
Sweden
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the leaflet:09.06.2023
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Information intended for healthcare professionals only:

Warnings and precautions for use

In order to avoid the risks associated with infusion at a rate higher than recommended, it is recommended to perform it continuously and under appropriate control, if possible using a volumetric pump.
Since the use of a central vein for infusion is associated with an increased risk of infection, when inserting and handling the catheter, it is recommended to strictly follow the principles of aseptic procedure to avoid any infection.
It is recommended to monitor glucose and electrolyte levels in serum, osmolality and fluid balance and acid-base balance, as well as to perform liver enzyme tests.
In case of any signs or symptoms of anaphylactic reaction (such as fever, chills, rash or shortness of breath), the infusion should be stopped immediately.
SmofKabiven extra Nitrogen EF should not be administered simultaneously with blood in the same infusion set, due to the risk of pseudoagglutination.

Method of administration

Intravenous administration, central vein infusion.
In order to ensure complete parenteral nutrition, it is recommended to add micronutrients, electrolytes and vitamins to SmofKabiven extra Nitrogen EF, according to the patient's needs.

Dosage

Adult patients
Recommended dosage
The dose range is from 13 to 31 ml of SmofKabiven extra Nitrogen EF/kg body weight/day, which provides from 0.14 to 0.32 g of nitrogen/kg body weight/day (from 0.85 to 2.0 g of amino acids/kg body weight/day) and from 12 to 28 kcal/kg body weight/day of total energy (from 8 to 19 kcal/kg body weight/day of non-protein energy).
Infusion rate
The maximum infusion rate of glucose is usually 0.25 g/kg body weight/hour, amino acids 0.1 g/kg body weight/hour, and fats 0.15 g/kg body weight/hour.
The infusion rate should not exceed 1.5 ml/kg body weight/hour (which corresponds to 0.13 g of glucose, 0.10 g of amino acids and 0.04 g of fats/kg body weight/hour). The recommended infusion time is from 14 to 24 hours.
Intradialytic parenteral nutrition (IDPN)
In clinically stable adult patients undergoing chronic renal replacement therapy, the maximum infusion rate during intradialytic parenteral nutrition (IDPN) is 3.0 ml/kg body weight/hour (which corresponds to 0.20 g/kg body weight/hour of amino acids, 0.25 g/kg body weight/hour of glucose and 0.09 g/kg body weight/hour of fats). The infusion volume in IDPN should be dependent on the difference between oral food intake and recommended nutrient intake, unavoidable loss of nutrients due to renal replacement therapy, as well as individual metabolic tolerance of the patient. The infusion time in IDPN usually lasts from 3 to 5 hours, depending on the patient's needs and the planned duration of the renal replacement therapy session. The maximum recommended daily dose remains unchanged
Maximum daily dose
The maximum daily dose depends on the patient's clinical condition and may change 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 should be up to 31 ml/kg body weight/day and should be regularly adjusted to the needs of the pediatric patient, which may vary significantly more than in adult patients.
Infusion rate
The recommended maximum infusion rate is 1.8 ml/kg body weight/hour (which corresponds to 0.12 g of amino acids/kg body weight/hour, 0.15 g of glucose/kg body weight/hour and 0.05 g of fats/kg body weight/hour).
Except in special situations requiring careful monitoring, when using the recommended maximum infusion rate, the infusion time should not exceed 17 hours.
The recommended infusion time is from 12 to 24 hours.
Maximum daily dose
The maximum daily dose is variable depending on the patient's clinical condition and may change even 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 EF can be dosed as in adult patients.

Special precautions for disposal and preparation of the medicine 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, particle-free, and the fat emulsion is white and homogeneous. .The contents of the three separate chambers should be mixed before use, as well as before adding other substances through the dedicated port.
After removing the protective covers, the bag should be turned over several times to mix all the components of the medicine and obtain a homogeneous mixture, in which no signs of phase separation are visible. The medicine is for single use only. Any unused residue of the medicine remaining after infusion should be destroyed.
Compatibility
Compatibility data are available for Dipeptiven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant and Soluvit N in specified quantities and at specified electrolyte concentrations.
When adding electrolytes, their quantities already present in the bag should be taken into account to meet the patient's clinical needs. Available data confirm the possibility of adding the above-mentioned medicines to the activated bag in accordance with the table below:
Compatibility range: stable for 7 days, i.e. 6 days stored at a temperature of 2-8 °C, and then 24 hours at a temperature of 20-25 °C.
Information on compatibility with other additives and storage times of different mixtures will be available on request.
Any additives should be mixed with the medicine 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 a temperature of 20-25 °C. From a microbiological point of view, the medicine should be used immediately.
Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not normally exceed 24 hours at a temperature of 2-8 °C, unless mixing took place in controlled and validated aseptic conditions.
Shelf life after mixing with additional substances
Physical and chemical stability of the mixed contents of the three-chamber bag with additional substances has been demonstrated for up to 7 days, i.e. 6 days at a temperature of 2-8 °C, and then 24 hours at a temperature of 20-25 °C, including the infusion time. From a microbiological point of view, the medicine should be used immediately after adding other components. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not normally exceed 24 hours at a temperature of 2-8 °C, unless mixing took place in controlled and validated aseptic conditions.

SmofKabiven extra Nitrogen EF Instructions for preparing the bag for use

• 1. Notch in the outer bag
• 2. Bag handle
• 3. Hole for hanging the bag
• 4. Welds separating the individual chambers of the bag
• 5. Blind port (used only in production)
• 6. Port for administering additional substances
• 7. Infusion port
• 8. Oxygen absorber

1. Removing the outer bag

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

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, roll the bag firmly towards the ports, first with the right hand, and then, applying constant pressure, with the left hand, until the vertical welds break. They open under the pressure of the liquid. The welds can also be opened before removing the outer bag. Note:the liquid mixes easily, even though the horizontal weld remains intact.

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

3. Final preparation steps

• Place the bag on a flat, even surface again. Just before administering additional substances, remove the labeled plug that protects the white port for administering additional substances (A).

Note:the membrane of the port for administering additional substances is sterile.

• Hold the base of the port for administering additional substances. Introduce the needle and inject the additional substances (with known compatibility) through the center of the injection site (B).
• Mix the contents of the bag thoroughly after adding each component by turning the bag over three times after each addition. Use syringes with needles with a diameter of 18 to 23 G and a maximum length of 40 mm.

• Just before connecting the infusion set, remove the plug that protects 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.
• Hold the base of the infusion port.
• Insert the spike of the infusion set into the infusion port. To ensure good fixation of the spike, insert it to its full length. Note:the inner surface of the infusion port is sterile.

4. Hanging the bag

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