Description

SMOFKABIVEN NTENSE is a specialized emulsion designed for intravenous infusion, providing essential parenteral nutrition for adult patients and children aged two years and above. It is particularly beneficial when oral or enteral nutrition is not feasible, insufficient, or contraindicated. Administered by healthcare professionals, this product is infused via a central vein, ensuring precise nutritional support tailored to individual needs.

Formulation

The product is supplied in a multi-chamber bag system, crafted from Biofine film, complete with an overpouch and oxygen absorber. The chambers contain:

• Amino Acid Solution with Electrolytes
• Glucose Solution
• Lipid Emulsion

The lipid component, SMOFlipid, comprises soya oil, medium chain triglycerides, olive oil, and fish oil, offering a rich source of omega-3 fatty acids.

Composition

Each 1012 mL bag typically includes:

• Amino Acids: 6.5%
• Lipids: 2.9%
• Glucose: 8.5%
• Electrolytes: 0.7%

The active ingredients encompass a comprehensive range of amino acids, electrolytes, and glucose, alongside excipients such as glycerol, egg lecithin, and dl-α-tocopherol.

Physical Characteristics

Before mixing, the glucose and amino acid solutions are clear and colourless to slightly yellow, while the lipid emulsion is white and homogeneous. After mixing, the emulsion remains white and homogeneous, with an osmolality of approximately 1800 mOsm/kg water and a pH of around 5.6.

Packaging

Available in various sizes, including 1.012 L and 2.025 L bags, SMOFKABIVEN NTENSE is provided in packs of one or four bags, depending on market availability.

Administration

The infusion is tailored to the patient's clinical condition, body weight, and nutritional requirements, with a maximum recommended daily dose of 35 mL per kg body weight. It is not suitable for neonates or infants under two years of age.

Contraindications

Contraindications include hypersensitivity to fish, egg, soya, peanut protein, or corn, severe hyperlipidaemia, and certain metabolic disorders. Careful monitoring is advised for patients with specific health conditions, and the product should not be infused simultaneously with blood in the same set.

Storage

SMOFKABIVEN NTENSE should be stored below 25°C, protected from light, and not frozen. The shelf life is 24 months before mixing, with stability maintained for up to 36 hours at 25°C after mixing.

Regulatory Information

This prescription-only medicine is not scheduled as a controlled substance in Australia and is intended for use under medical supervision only. Proper handling ensures safe and effective nutritional support for those in need.