Description

SMOFKABIVEN NTENSE is a specialized emulsion designed for intravenous infusion, providing comprehensive parenteral nutrition. It is intended for adult patients and children aged two years and above, particularly when oral or enteral nutrition is not feasible. This product is essential in clinical settings where nutritional support is critical, offering a balanced formulation of amino acids, lipids, glucose, and electrolytes.

Formulation

• Amino Acids: Includes essential amino acids such as alanine, arginine, and lysine, supporting protein synthesis and metabolic functions.
• Lipids: Composed of soya oil, medium chain triglycerides, olive oil, and fish oil, rich in omega-3 fatty acids, aiding in energy provision and cellular health.
• Glucose: Serves as a primary energy source, available in concentrations ranging from 8.5% to 12.7%.
• Electrolytes: Contains essential minerals like calcium, magnesium, and potassium, crucial for maintaining physiological balance.

Packaging

The product is housed in a multi-chamber Biofine bag system, separating amino acids, glucose, and lipid emulsion until use. This design ensures stability and ease of administration. Each bag is supplied with an overpouch and oxygen absorber, and is latex-free. Available in various sizes, the bags are intended for single use, requiring aseptic mixing before administration.

Administration

SMOFKABIVEN NTENSE is administered via intravenous infusion into a central vein, tailored to individual patient needs. Healthcare professionals must manage the dosage and infusion rate, ensuring safe and effective delivery. It is crucial to discard any unused portions to maintain sterility.

Contraindications and Precautions

This product is not suitable for individuals with hypersensitivity to its components, such as fish, egg, or soya proteins. Other contraindications include severe liver insufficiency, uncontrolled hyperglycaemia, and certain metabolic disorders. Careful monitoring is advised for patients with conditions like renal failure, diabetes, or impaired lipid metabolism.

Storage Instructions

• Temperature: Store below 25°C and do not freeze.
• Light Protection: Keep in the original container to protect from light.
• Shelf Life: Before mixing, the shelf life is up to 24 months. After mixing, it remains stable for 36 hours at 25°C or up to 24 hours if refrigerated.

Additional Information

SMOFKABIVEN NTENSE does not contain common allergens such as gluten or lactose, nor does it include preservatives. Its osmolarity and pH levels are carefully balanced to align with physiological needs, ensuring compatibility and safety. As a prescription-only product, it must be used under medical supervision, aligning with regulatory standards to provide essential nutritional support in complex clinical scenarios.