Smofkabiven extra Nitrogen

Package Leaflet: Information for the User

SmofKabiven extra Nitrogen, infusion emulsion

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 through a drip (intravenous infusion). The packaging of the medicine consists of a plastic bag containing amino acids (components necessary for protein production), glucose (carbohydrates), fats (lipids), and salts (electrolytes). The medicine can be used in adult patients and children over 2 years of age.
SmofKabiven extra Nitrogen is administered by medical professionals when other methods of nutrition are insufficient or impossible.

2. Important information before using SmofKabiven extra Nitrogen

Do not use SmofKabiven extra Nitrogen if you have:

• allergy to active substances or any other component of this medicine (listed in section 6);
• allergy to fish protein or egg;
• allergy to peanuts or soy (SmofKabiven extra Nitrogen contains soybean oil);
• too high a level of fat in the blood (hyperlipidemia);
• severe liver dysfunction;
• 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);
• increased levels of any of the electrolytes contained in SmofKabiven extra Nitrogen in the blood (serum);
• 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 overall condition, e.g. severe post-traumatic condition, uncontrolled diabetes, acute myocardial infarction, stroke, thrombosis, metabolic acidosis (a condition characterized by too much acidic substance in the blood), severe infection (severe sepsis), coma, fluid deficiency (hypotonic dehydration).

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

Warnings and precautions

Before starting SmofKabiven extra Nitrogen, discuss with your doctor if you have:

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

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

Children and adolescents

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

SmofKabiven extra Nitrogen and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use SmofKabiven extra Nitrogen

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will choose an individual dose based on your body weight and clinical condition.
SmofKabiven extra Nitrogen is administered only by medical professionals.

Using more than the recommended dose of SmofKabiven extra Nitrogen

It is unlikely that you will receive too much SmofKabiven extra Nitrogen, 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 affect up to 1 in 10 people): slight increase in body temperature.
Uncommon side effects(may affect up to 1 in 100 people): high levels of liver enzymes in the blood, loss of appetite, nausea, vomiting, chills, dizziness, and headache.
Rare side effects(may affect up to 1 in 1000 people): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia). Allergic reactions (which can cause symptoms such as swelling, fever, drop in blood pressure, rash, blisters, redness, headache). Feeling hot and cold. Paleness. Slight cyanosis of the lips and skin (related to hypoxia). Neck, back, bone, chest, and lumbar pain.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Store the 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 carton. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What SmofKabiven extra Nitrogen 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
calcium chloride (as dihydrate)
0.28
sodium glycerophosphate (as monohydrate)
2.3
magnesium sulfate (as heptahydrate)
0.61
potassium chloride
2.3
sodium acetate (as trihydrate)
1.6
zinc sulfate (as heptahydrate)
0.0066
glucose (as monohydrate)
soybean oil purified
8.7
medium-chain triglycerides
8.7
olive oil purified
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 (for pH adjustment), sodium oleate, glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection.

What SmofKabiven extra Nitrogen looks like and contents of the pack

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

Fresenius Kabi AB
Rapsgatan 7
751 74 Uppsala
Sweden
For further information, please contact the marketing authorization holder's representative:
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 package 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 greater than recommended, it is recommended to perform it continuously and under proper 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 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, vitamins, and electrolytes (taking into account the electrolytes already present in SmofKabiven extra Nitrogen) to the medicine, according to the patient's needs.

Dosage

Adult patients
Recommended dosage
The dose range is from 13 to 31 ml of SmofKabiven extra Nitrogen/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 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.
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
A dose of up to 31 ml/kg body weight/day 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 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, and the fat emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use and before adding any other substances through the designated port.
After removing the protective covers, roll the bag several times to mix all the components of the medicine and obtain a homogeneous mixture in which no signs of phase separation are visible.
For single use only. Any unused 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 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 following table:
Compatibility range: stable for 7 days, i.e. 6 days stored at 2-8 °C, and then 24 hours at 20-25 °C.

Note: This table is intended to demonstrate compatibility. It does not provide dosage guidelines.
Before prescribing the above-mentioned medicines, read the approved package leaflets.
Information on compatibility with other additives and storage times of different mixtures is available on request.
Any additives should be combined 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 triple-chamber bag has been demonstrated for 48 hours at 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 exceed 24 hours at 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 triple-chamber bag with additional substances has been demonstrated for up to 7 days, i.e. 6 days at 2-8 °C, and then 24 hours at 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 exceed 24 hours at 2-8 °C, unless mixing took place in controlled and validated aseptic conditions.

SmofKabiven extra Nitrogen 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 tear it along the top edge, starting from the notch near the ports (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 with the left hand, applying steady pressure until the vertical welds open. 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. Just before administering additional substances, remove the labeled plug from 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. Insert 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 from 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 its entire 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.