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SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

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About the medicine

How to use SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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 further 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.

Contents of the pack:

  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. Storage of 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 emulsion for infusion that is administered into your blood through a drip (intravenous infusion). The product contains amino acids (components used in the formation of proteins), glucose (carbohydrates), lipids (fat), and salts (electrolytes), in a plastic bag and can be administered to adults and children from 2 years of age.

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

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you 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 soy, you should not use this product. SmofKabiven extra Nitrogen contains soybean oil
  • if you have too much fat in your blood (hyperlipidemia)
  • if you have severe liver disease
  • if you have blood coagulation problems (coagulation disorders)
  • if your body has problems using amino acids
  • if you have severe kidney disease without the possibility of dialysis
  • if you are in acute shock
  • if you have too much sugar in your blood (hyperglycemia) that is not controlled
  • if you have high levels of salts (electrolytes) in your blood (serum) included in SmofKabiven extra Nitrogen
  • if you have fluid in your lungs (acute pulmonary edema)
  • if you have too much fluid in your body (overhydration)
  • if you have untreated heart failure
  • if you have a defect in your blood coagulation system (hemophagocytic syndrome)
  • if you are in an unstable situation, such as after severe trauma, uncontrolled diabetes mellitus, acute heart attack, stroke, blood clot, metabolic acidosis (a condition that leads to too much acid in your blood), severe infection (sepsis), coma, and if you do not have enough fluid in your body (hypotonic dehydration)
  • in newborn babies or children under 2 years of age

Warnings and precautions

Consult 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 experience fever, rash, swelling, difficulty breathing, chills, sweating, nausea, or vomiting, inform your healthcare professional immediately, as these symptoms could be caused by an allergic reaction or because you are receiving too much of the medicine.

Your doctor will need to regularly check your blood through liver function tests and other values.

Children and adolescents

SmofKabiven extra Nitrogen is not intended for newborn babies or children under 2 years of age.

SmofKabiven extra Nitrogen can be administered to children from 2 to 16/18 years of age.

Using SmofKabiven extra Nitrogen with other medicines

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

Pregnancy and breastfeeding

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

Driving and using machines

This is not relevant, as this medicine is administered in the hospital.

3. How to use SmofKabiven extra Nitrogen

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

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

If you use more SmofKabiven extra Nitrogen than you should

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, SmofKabiven extra Nitrogen can cause side effects, although not everybody gets them.

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

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

Rare(may affect up to 1 in 1000 people): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia). Hypersensitivity reactions (which can cause symptoms such as swelling, fever, drop in blood pressure, skin rash, hives, redness, headache). Feelings of cold and heat. Paleness. Blue discoloration of the lips and skin (due to lack of oxygen in the blood). Pain in the neck, back, bones, chest, and lumbar region.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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.

Keep in the outer bag. Do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the bag and carton. The expiry date is the last day of the month stated.

6. Container Content and Additional Information

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 hydrate)

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)

85

Refined soybean oil

8.7

Medium-chain triglycerides

8.7

Refined olive oil

7.2

Fish oil rich in omega-3 fatty acids

4.3

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 injectable preparations.

Appearance of the Product and Container Content

The glucose and amino acid solutions are transparent, colorless, or slightly yellow and particle-free. The lipid emulsion is white and homogeneous.

Container 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 Last Revision of this Leaflet: March 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

------------------------------------------------------------------------------------------------------------------------

This information is intended exclusively for healthcare professionals:

Special Warnings and Precautions for Use

To avoid the risks associated with too rapid perfusion rates, it is recommended to use continuous and well-controlled perfusion, if possible using a perfusion pump.

Since the use of a central vein is associated with a high risk of infection, strict aseptic precautions should be taken to avoid any 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.

Upon any sign or symptom of anaphylactic reaction (such as fever, shivering, skin rash, or dyspnea), perfusion should be immediately discontinued.

SmofKabiven extra Nitrogen should not be administered simultaneously with blood in the same perfusion equipment due to the risk of pseudoagglutination.

Method of Administration

Intravenous route, perfusion in a central vein.

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

Posology

Adults

Dosage:

The dose range of 13-31 ml SmofKabiven extra Nitrogen/kg body weight/day will provide 0.14 – 0.32 g of nitrogen/kg body weight/day (corresponding 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).

Perfusion Rate

The maximum perfusion 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 perfusion rate should not exceed 1.5 ml/kg body weight/hour (corresponding to 0.13 g of glucose, 0.10 g of amino acids, and 0.04 g of lipids/kg body weight/h). The recommended perfusion period is 14 – 24 hours.

Maximum Daily Dose:

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

Pediatric Population

Children (2-11 years)

Dosage:

The dose of up to 31 ml/kg body weight/day should be adjusted regularly according to the pediatric patient's requirements, which vary more than in adult patients.

Perfusion Rate:

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

The recommended perfusion 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 can be used in adolescents in the same way as in adults.

Disposal Precautions

Do not use if the container is damaged.

Use only if the amino acid and glucose solutions are transparent and colorless or slightly yellow, and if the lipid emulsion is white and homogeneous. The contents of the three separate chambers should be mixed before use and before making any additions through the additive port. After opening the peel-type seals, the bag should be inverted several times to ensure a homogeneous mixture, which does not show evidence of phase separation.

For single use. Any remaining mixture should be discarded after perfusion.

Compatibility

Compatibility data are available for the products Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adult/Infant, and Soluvit lyophilized in defined quantities and solutions with electrolytes in defined concentrations. When adding electrolytes, the amounts already present in the bag should 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

Units

Maximum Total Content

Size of the SmofKabiven Extra Nitrogen bag

ml

506

1012

1518

2025

2531

Additive

Volume

Dipeptiven

ml

0-150

0 - 300

0 - 300

0 - 300

0 - 300

Supliven

ml

0 - 10

0 - 20

0 - 20

0 - 20

0 - 20

Soluvit

vial

0 - 1

0 - 2

0 - 2

0 - 2

0 - 2

Vitalipid Adult/Infant

ml

0 - 10

0 - 20

0 - 20

0 - 20

0 - 20

Electrolyte Limits1

Concentration

Sodium

mmol

≤ 150

≤ 150

≤ 150

≤ 150

≤ 150

Potassium

mmol

≤ 150

≤ 150

≤ 150

≤ 150

≤ 150

Calcium

mmol

≤ 5

≤ 5

≤ 5

≤ 5

≤ 5

Magnesium

mmol

≤ 5

≤ 5

≤ 5

≤ 5

≤ 5

Organic phosphate (Glycophos)

mmol

≤ 30

≤ 30

≤ 30

≤ 30

≤ 30

Zinc

mmol

≤ 0.2

≤ 0.2

≤ 0.2

≤ 0.2

≤ 0.2

Selenium

µmol

≤ 2

≤ 2

≤ 2

≤ 2

≤ 2

1includes the amounts ofall products.

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

In the case of products with a trade name, before prescribing them, consult the approved technical sheet.

There are data on compatibility with other additives and the shelf life of the different mixtures, available upon request.

Additions should be made aseptically.

Validity Period after Mixing the Bag Chambers

The physical and chemical stability of the mixed three-chamber bag has been demonstrated for 48 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time until use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixture has been made under controlled and validated aseptic conditions.

Validity Period after Mixing with Additives

Physical and chemical stability has been demonstrated for the mixed three-chamber bag with additives (see section 6.6) 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 point of view, the product should be used immediately after making the additions. If not used immediately, the storage time until use and the conditions prior to use are the responsibility of the user. The storage time should not normally exceed 24 hours at 2-8°C, unless the addition of supplements has been made under controlled and validated aseptic conditions.

Instructions for the Use of SmofKabiven extra Nitrogen

The Bag

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

Diagram of medical device with numbered connections from 1 to 8, showing tubes and valves connected to a main container

  1. Notches on the overbag
  2. Handle
  3. Hole for hanging the bag
  4. Breakable seals
  5. Blind port (used only during manufacturing)
  6. Additive port
  7. Perfusion port
  8. Oxygen absorber
  1. Opening the overbag

Hands holding an auto-injector device with arrows indicating direction of injection in thigh and abdomen

  • To remove the overbag, hold it in a horizontal position and tear along the notch towards the ports along the top edge (A)
  • Then, simply tear along the container; separate the overbag and discard it along with the oxygen absorber (B).
    1. Mixing

Hand holding a medical device with connected tubes and adjustment valves for oxygen administration

Hands holding a device with two tubes and a Y-shaped connection for drug administration

Hands holding a medical device with connected tubes and a small cylinder

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

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

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

Hand holding a device with curved arrows indicating movement and a button pressed at the base

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

Hand holding a device with cylinder and plunger connecting a needle to a transparent cartridge

  • Place the bag back on a flat surface. Just before injecting the additives, break the white additive port by the arrow mark (A).

Note:The additive port membrane is sterile.

  • Hold the base of the additive port. Insert the needle, inject the additives (of known compatibility) through the center of the injection point (B).
  • Mix completely between each addition, inverting the bag three times. Use syringes with 18-23 gauge needles and a maximum length of 40 mm.

Auto-injector device with inserted cartridge and hand pressing activation button in two stages

  • Just before inserting the perfusion set, break the blue perfusion port by the arrow mark (A).

Note:The perfusion port membrane is sterile.

  • Use non-vented perfusion equipment or close the air inlet of the vented equipment.
  • Hold the base of the perfusion port.
  • Insert the spike through the perfusion port. The spike should be fully inserted to ensure its retention.

Note:The inside of the perfusion port is sterile.

  1. Hanging the bag

Needle entering the skin with a visible suture knot under the skin surface and a thread end protruding

  • Hang the bag by the ring under the hanger
  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Alternatives to SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION
    Dosage form:  INJECTABLE PERFUSION, 3.92 g / 1.26 g / 7.21 g / 3.36 g / 4.2 g / 5.11 g / 2.94 g / 2.8 g / 4.76 g / 5.07 g / 4.06 g / 14.49 g / 0.28 g / 8.05 g / 3.5 g / 200 g
    Active substance:  combinations
    Manufacturer:  Baxter S.L.
    Prescription required
    Dosage form:  INJECTABLE INFUSION, 3.5 g / 200 g / 5.22 g / 1.88 g / 3.92 g / 1.26 g / 7.21 g / 3.36 g / 4.2 g / 5.11 g / 2.94 g / 2.8 g / 662 mg / 1.02 g / 4.76 g / 5.15 g / 5.07 g / 4.06 g / 14.49 g / 0.28 g / 8.05 g
    Active substance:  combinations
    Manufacturer:  Baxter S.L.
    Prescription required
    Dosage form:  INJECTABLE PERFUSION, 4.25 g / 300 g / 5.22 g / 1.54 g / 4.76 g / 1.53 g / 8.76 g / 4.08 g / 5.1 g / 6.2 g / 3.57 g / 3.4 g / 662 mg / 1.02 g / 5.78 g / 5.94 g / 6.16 g / 4.93 g / 17.6 g / 0.34 g / 9.78 g
    Active substance:  combinations
    Manufacturer:  Baxter S.L.
    Prescription required

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

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  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Lina Travkina

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Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Frequently Asked Questions

Is a prescription required for SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION?
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION?
The active ingredient in SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION is combinations. This information helps identify medicines with the same composition but different brand names.
Who manufactures SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION?
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION?
Other medicines with the same active substance (combinations) include CLINIMIX N12G20 SOLUTION FOR INFUSION, CLINIMIX N12G20E SOLUTION FOR INFUSION, CLINIMIX N14G30E SOLUTION FOR INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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