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
Active Ingredients
Strength: 2.8g/1000ml
Strength: 8.7g/1000ml
Strength: 3.3g/1000ml
Strength: 2.3g/1000ml
Strength: 0.61g/1000ml
Strength: 3.3g/1000ml
Strength: 7.2g/1000ml
Strength: 4.3g/1000ml
Strength: 7.2g/1000ml
Strength: 2.3g/1000ml
Strength: 4.3g/1000ml
Strength: 8.7g/1000ml
Strength: 4.1g/1000ml
Strength: 0.65g/1000ml
Strength: 0.26g/1000ml
Strength: 0.28g/1000ml
Strength: 0.0066g/1000ml
Strength: 85g/1000ml
Strength: 4.3g/1000ml
Strength: 1.3g/1000ml
Strength: 9.2g/1000ml
Strength: 7.3g/1000ml
Strength: 2.9g/1000ml
Strength: 2g/1000ml
Strength: 1.6g/1000ml
Strength: 7.9g/1000ml
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.