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SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION [SIN16135P]

Active ingredients: SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

Last updated 26 October 2025

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Product Info
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications

Product Info

SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

[SIN16135P]

Product information

Active Ingredient and Strength

CALCIUM CHLORIDE DIHYDRATE EQV. CALCIUM CHLORIDE - 0.28 G/1,000 ML
FISH OIL, RICH IN OMEGA-3 ACIDS - 4.3 G/1,000 ML
GLUCOSE MONOHYDRATE EQV. GLUCOSE - 85 G/1,000 ML
GLYCINE - 7.2 G/1,000 ML
L-ALANINE - 9.2 G/1,000 ML
L-ARGININE - 7.9 G/1,000 ML
L-HISTIDINE - 2 G/1,000 ML
L-ISOLEUCINE - 3.3 G/1,000 ML
L-LEUCINE - 4.8 G/1,000 ML
L-LYSINE ACETATE EQUV. L-LYSINE - 4.3 G/1,000 ML
L-METHIONINE - 2.8 G/1,000 ML
L-PHENYLALANINE - 3.3 G/1,000 ML
L-PROLINE - 7.3 G/1,000 ML
L-SERINE - 4.3 G/1,000 ML
L-THREONINE - 2.9 G/1,000 ML
L-TRYPTOPHAN - 1.3 G/1,000 ML
L-TYROSINE - 0.26 G/1,000 ML
L-VALINE - 4.1 G/1,000 ML
MAGNESIUM SULFATE HEPTAHYDRATE AS MAGNESIUM SULFATE - 0.61 G/1,000 ML
OLIVE OIL, REFINED - 7.2 G/1,000 ML
POTASSIUM CHLORIDE - 2.3 G/1,000 ML
SODIUM ACETATE TRIHYDRATE AS SODIUM ACETATE - 1.6 G/1,000 ML
SODIUM GLYCEROPHOSPHATE HYDRATED AS SODIUM GLYCEROPHOSPHATE - 2.3 G/1,000 ML
SOY-BEAN OIL, REFINED - 8.7 G/1,000 ML
TAURINE - 0.65 G/1,000 ML
TRIGLYCERIDES, MEDIUM-CHAIN - 8.7 G/1,000 ML
ZINC SULFATE HEPTAHYDRATE AS ZINC SULFATE - 0.0066 G/1,000 ML

Dosage Form

INJECTION, EMULSION

Manufacturer and Country

FRESENIUS KABI AB, SITE UPPSALA - SWEDEN

Registration Number

SIN16135P

Licence Holder

FRESENIUS KABI (SINGAPORE) PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

B05BA10

4.1 Therapeutic indications

Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

4.2 Posology and method of administration

Posology

The appearance of the product after mixing the 3 chambers is a white emulsion.

The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake.

The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).

Adults

The requirements are 0.10‐0.15 g nitrogen/kg bw/day (0.6‐0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15‐0.25 g nitrogen/kg bw/day (0.9‐1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.

Dosage:
The dosage range of 13‐31 ml SmofKabiven extra Nitrogen/kg bw/day corresponds to 0.14‐0.32 g nitrogen/kg bw/day (0.85‐2.0 g amino acids/kg bw/day) and 12‐28 kcal/kg bw/day of total energy (8‐19 kcal/kg bw/day of non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.

Infusion rate:
The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.

The infusion rate should not exceed 1.5 ml/kg bw/h (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 g lipids/kg bw/h). The recommended infusion period is 14‐24 hours.

Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2.0 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

Paediatric population

Children (2‐11 years)

Dosage:
The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.

Infusion rate:
The recommended maximum infusion rate is 1.8 ml/kg bw/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, do not use an infusion period longer than 17 hours, except in exceptional cases and with careful monitoring.

The recommended infusion period is 12–24 hours.

Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

Adolescents (12–16/18 years)

In adolescents, SmofKabiven extra Nitrogen can be used as in adults.

Method of administration

Intravenous use, infusion into a central vein.

The five different package sizes of SmofKabiven extra Nitrogen are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to SmofKabiven extra Nitrogen according to the patients need.

For instructions on preparation of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

  • Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

  • Severe hyperlipidemia

  • Severe liver insufficiency

  • Severe blood coagulation disorders

  • Congenital errors of amino acid metabolism

  • Severe renal insufficiency without access to hemofiltration or dialysis

  • Acute shock

  • Uncontrolled hyperglycaemia

  • Pathologically elevated serum levels of any of the included electrolytes

  • General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency

  • Hemophagocytotic syndrome

  • Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma)

  • Neonates and infants under 2 years of age