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HSA Product

SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

Product approved by Health Sciences Authority (SG)

Basic Information

SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

INJECTION, EMULSION

Regulatory Information

SIN16135P

March 24, 2021

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

June 3, 2025

XB05BA10

Company Information

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Active Ingredients

L-Methionine

Strength: 2.8g/1000ml

Soy-bean oil, refined

Strength: 8.7g/1000ml

L-Isoleucine

Strength: 3.3g/1000ml

Potassium Chloride

Strength: 2.3g/1000ml

L-Phenylalanine

Strength: 3.3g/1000ml

Olive oil, refined

Strength: 7.2g/1000ml

L-Lysine acetate equv. L-Lysine

Strength: 4.3g/1000ml

Glycine

Strength: 7.2g/1000ml

L-Serine

Strength: 4.3g/1000ml

Triglycerides, medium-chain

Strength: 8.7g/1000ml

L-Valine

Strength: 4.1g/1000ml

Taurine

Strength: 0.65g/1000ml

L-Tyrosine

Strength: 0.26g/1000ml

Fish oil, rich in omega-3 acids

Strength: 4.3g/1000ml

L-Tryptophan

Strength: 1.3g/1000ml

L-Alanine

Strength: 9.2g/1000ml

L-Proline

Strength: 7.3g/1000ml

L-Threonine

Strength: 2.9g/1000ml

L-Histidine

Strength: 2g/1000ml

L-Arginine

Strength: 7.9g/1000ml

L-Leucine

Strength: 4.8g/1000ml

Detailed Information

Contraindications

**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

Indication Information

**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.

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