SMOFKabiven Extra Nitrogen emulsion for infusion

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

SmofKabiven extra Nitrogen emulsion for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What SmofKabiven extra Nitrogen is and what it is used for
2. What you need to know before you use 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 into your blood through an intravenous drip (intravenous infusion). The product contains amino acids (components used in protein formation), glucose (carbohydrates), lipids (fat), and salts (electrolytes), all contained in a plastic bag, and can be administered to adults and children aged 2 years and older.

A healthcare professional will administer SmofKabiven extra Nitrogen to you when other forms of nutrition are insufficient or not possible.

2. What you need to know before starting to use SmofKabiven extra Nitrogen

Do not use SmofKabiven extra Nitrogen:

• if you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6)
• if you are allergic to fish or eggs
• if you are allergic to peanuts or soybeans, you should not use this product. SmofKabiven extra Nitrogen contains soybean oil
• if you have too many lipids in your blood (hyperlipidemia)
• if you have severe liver disease
• if you have blood clotting disorders (coagulation abnormalities)
• if your body has problems utilizing amino acids
• if you have severe kidney disease without possibility of dialysis
• if you are in acute shock
• if you have high blood sugar (hyperglycemia) that is not controlled
• if you have high levels in your blood (serum) of the salts (electrolytes) contained in SmofKabiven extra Nitrogen
• if you have fluid in your lungs (acute pulmonary edema)
• if you have too much fluid in your body (hyperhydration)
• if you have untreated heart failure
• if you have a defect in your blood clotting system (hemophagocytic syndrome)
• if you are in an unstable condition, such as after severe trauma, uncontrolled diabetes mellitus, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance leading to excess acid in your blood), severe infection (severe sepsis), coma, or if you do not have enough fluid in your body (hypotonic dehydration)
• in newborns or children under 2 years of age

Warnings and precautions

Talk to your doctor before starting to use SmofKabiven extra Nitrogen if you have:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothyroidism (thyroid problems)
• sepsis (severe infection)

If during the infusion you develop fever, skin rash, swelling, difficulty breathing, chills, sweating, nausea, or vomiting, inform your healthcare professional immediately, as these symptoms could be due to an allergic reaction or because you are receiving too much of the medicine.

Your doctor will need to regularly monitor your blood through tests assessing 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 aged 2 to 16/18 years.

Use of SmofKabiven extra Nitrogen with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There is no information available on the use of SmofKabiven extra Nitrogen during pregnancy or breastfeeding. Therefore, SmofKabiven extra Nitrogen should only be administered to pregnant or breastfeeding women if considered necessary by the doctor. However, the use of SmofKabiven extra Nitrogen may be considered during pregnancy and breastfeeding if advised by your doctor.

Driving and using machines

Not applicable, as this medicine is administered in a hospital setting.

3. How to use SmofKabiven extra Nitrogen

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor again.

Your doctor will determine the dose for you individually, depending on your body weight and your condition. SmofKabiven extra Nitrogen will be administered to you by a healthcare professional.

If you use more SmofKabiven extra Nitrogen than you should

It is highly unlikely that you will receive too much medicine, as SmofKabiven extra Nitrogen will be administered by a healthcare professional.

4. Possible adverse effects

Like all medicines, SmofKabiven extra Nitrogen may cause adverse effects, although not all people will experience them.

Frequent (may affect up to 1 in 10 patients): a slight increase in body temperature.

Uncommon (may affect up to 1 in 100 patients): elevated blood (plasma) levels of liver components, loss of appetite, nausea, vomiting, chills, dizziness, and headache.

Rare (may affect up to 1 in 1,000 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, hives (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Bluish discoloration of lips and skin (due to lack of oxygen in the blood). Pain in the neck, back, bones, chest, and lumbar region.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SmofKabiven extra Nitrogen

Keep this medicine out of the sight and reach of children.

Store in the overpouch. Do not store above 25°C. Do not freeze.

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 indicated.

6. Contents of the pack and other information

SmofKabiven extra Nitrogen contains

The other components are: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (pH adjustment), sodium oleate, glacial acetic acid (pH adjustment), hydrochloric acid (pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Glucose and amino acid solutions are clear, colourless or slightly yellow, and free from particles. The lipid emulsion is white and homogeneous.

Pack sizes:

1 x 506 ml, 6 x 506 ml
1 x 1012 ml, 4 x 1012 ml
1 x 1518 ml, 4 x 1518 ml
1 x 2025 ml, 4 x 2025 ml
1 x 2531 ml, 3 x 2531 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.
C/ Marina 16-18
08005 Barcelona (Spain)

Manufacturer

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden

Date of the most recent review of this summary: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Warnings and special precautions for use

To avoid risks associated with excessively rapid infusion rates, continuous and well-controlled infusion is recommended, preferably using an infusion pump.

Since the use of a central vein is associated with a high risk of infection, strict aseptic precautions must be taken to prevent contamination during catheter insertion and handling.

Serum glucose, electrolytes, and osmolarity, as well as fluid balance, acid-base balance, and liver enzyme levels should be monitored.

If any sign or symptom of anaphylactic reaction occurs (such as fever, chills, skin rash, or dyspnea), infusion must be stopped immediately.

SmofKabiven extra Nitrogen should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.

Method of administration

Intravenous use, infusion into a central vein.

To provide complete parenteral nutrition, trace elements, vitamins, and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven extra Nitrogen) should be added to SmofKabiven extra Nitrogen according to the patient's needs.

Dosage

Adults

Dosage:

A dosage range of 13–31 ml of SmofKabiven extra Nitrogen/kg body weight/day provides 0.14–0.32 g of nitrogen/kg body weight/day (equivalent to 0.85–2.0 g of amino acids/kg body weight/day) and 12–28 kcal/kg body weight/day of total energy (8–19 kcal/kg body weight/day of non-protein energy).

Infusion rate:

The maximum infusion rate for glucose is 0.25 g/kg body weight/h, for amino acids 0.1 g/kg body weight/h, and for lipids 0.15 g/kg body weight/h.

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/h). The recommended infusion period is 14–24 hours.

Maximum daily dose:

The maximum daily dose varies depending on the patient's clinical condition and may even change from day to day. The recommended maximum daily dose is 31 ml/kg body weight/day.

Paediatric population

Children (2–11 years)

Dosage:

Doses up to 31 ml/kg body weight/day should be regularly adjusted according to the varying requirements of paediatric patients, which differ more than in adult patients.

Infusion rate:

The maximum infusion rate is 1.8 ml/kg body weight/h (corresponding to 0.12 g amino acids/kg/h, 0.15 g glucose/kg/h, and 0.05 g lipids/kg/h). At the recommended maximum infusion rate, infusion periods longer than 17 hours should not be used except in exceptional cases and under close monitoring.

The recommended infusion period is 12–24 hours.

Maximum daily dose:

The maximum daily dose varies with the patient's clinical condition and may even change from day to day. The maximum daily dose is 31 ml/kg body weight/day.

Adolescents (12–16/18 years)

SmofKabiven extra Nitrogen may be used in adolescents in the same way as in adults.

Disposal precautions

Do not use if the packaging is damaged.

Use only if the amino acid and glucose solutions are clear, colourless or slightly yellow, and if the lipid emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use, and before any addition through the additive port. After opening the peel seals, the bag should be inverted several times to ensure a homogeneous mixture without evidence of phase separation.

For single use only. Any unused mixture must be discarded after infusion.

Compatibility

Compatibility data are available for the branded products Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adult/Infant, and Soluvit lyophilisate in defined quantities, as well as for electrolyte solutions at defined concentrations. When adding electrolytes, the amounts already present in the bag must be taken into account according to the patient's clinical needs. The generated data support additions to the activated bag according to the following table:

Stable compatibility range for 7 days, i.e., 6 days of storage at 2–8°C followed by 24 hours at 20–25°C.

1includes quantities of all products.

Note: This table indicates compatibility. It is not a dosing guideline.

For products with brand names, consult the approved product information before prescribing.

Data are available on compatibility with other additives and on the shelf life of various mixtures; these are available upon request.

Additions must be made aseptically.

Shelf life after mixing the chambers of the bag

Physical and chemical stability of the mixed three-chamber bag has been demonstrated for 48 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time prior to use and the storage conditions are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the mixing was carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additives

In-use physicochemical stability of the mixed three-chamber bag with additives (see section 6.6) has been demonstrated for up to 7 days, i.e., 6 days at 2–8°C followed by 24 hours at 20–25°C, including the duration of administration. From a microbiological standpoint, the product should be used immediately after additives are added. If not used immediately, the storage time prior to use and the storage conditions are the responsibility of the user. Storage time should normally not exceed 24 hours at 2–8°C, unless the addition of supplements was performed under controlled and validated aseptic conditions.

Instructions for use of SmofKabiven extra Nitrogen

The bag

506 ml, 1012 ml, 1518 ml, 2025 ml, 2531 ml

1. Notches on the overpouch

2. Handle

3. Hanging hole

4. Breakable seals

5. Blind port (used only during manufacturing)

6. Addition port

7. Infusion port

8. Oxygen absorber

9. Opening the overpouch

• To remove the overpouch, hold it horizontally and tear along the notch towards the ports along the upper edge (A).
• Then simply tear along the package; separate and discard the overpouch together with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Roll the bag from the hanger end toward the port end, first with the right hand, then applying constant pressure with the left hand until the vertical peel seals have opened. The vertical peel seals open due to liquid pressure. The peel seals may also be opened before removing the overpouch.

Note: Liquids mix easily even if the horizontal seal remains closed.

506 ml, 1012 ml, 1518 ml, 2025 ml, 2531 ml

• Mix the contents of the three chambers by inverting the bag three times until the components are completely mixed.

3. Completion of preparation:

• Place the bag again on a flat surface. Shortly before injecting additives, break the white addition port at the arrow mark (A).

Note: The membrane of the additive port is sterile.

• Hold the base of the additive port. Insert the needle and inject additives (of known compatibility) into the center of the injection site (B).
• Mix thoroughly after each addition by inverting the bag three times. Use syringes with needles of gauge 18–23 and a maximum length of 40 mm.

• Shortly before inserting the infusion set, break the blue infusion port at the arrow mark (A).

Note: The membrane of the infusion port is sterile.

• Use a non-vented infusion set or close the air inlet of a vented infusion set.
• Hold the base of the infusion port.
• Insert the spike through the infusion port. The spike must be fully inserted to ensure retention.

Note: The inner part of the infusion port is sterile.

4. Hanging the bag

• Hang the bag by the ring located beneath the hanger