Smofkabiven Central 986ml Infusion

Smofkabiven Central 986ml Infusion is a multi-chambered emulsion containing amino acids, glucose, lipids, and electrolytes. It is used for parenteral nutrition in adults and children aged 2 years and above when oral or enteral feeding is not possible, insufficient, or contraindicated.

Benefits

This infusion provides complete nutritional support, offering a balanced mixture of carbohydrates, proteins, and lipids, along with essential electrolytes. It is particularly beneficial for patients experiencing malnutrition, those with gastrointestinal diseases that hinder adequate nutrient absorption, or individuals in critical conditions requiring controlled energy and macronutrient intake. The unique lipid profile, known as SMOFlipid, aims to deliver a well-balanced fatty acid composition and may support liver function.

Uses and Indications

• Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient, or contraindicated.
• Nutritional support for patients undergoing major surgery, critically ill individuals, or those with specific conditions such as oncology, bone marrow transplant, or liver transplant requiring parenteral nutrition.
• Patients who require immunomodulating and anti-inflammatory nutritional treatment.
• Patients with high nitrogen requirements or those at risk of, or with already increased, liver parameters.

The Smofkabiven Central 986ml Infusion contains:

• Amino acid solution (500ml) with Alanine (7.0g), Arginine (6.0g), Glycine (5.5g), Histidine (1.5g), Isoleucine (2.5g), Leucine (3.7g), Lysine (as acetate) (3.3g), Methionine (2.2g), Phenylalanine (2.6g), Proline (5.6g), Serine (3.2g), Taurine (0.50g), Threonine (2.2g), Tryptophan (1.0g), Tyrosine (0.20g), Valine (3.1g).
• Glucose 42% (298ml), providing Glucose (monohydrate) (125g).
• Lipid emulsion (188ml) comprising Soya-bean oil, refined (11.3g), Medium-chain triglycerides (11.3g), Olive oil, refined (9.4g), and Fish oil, rich in omega-3-acids (5.6g).
• Electrolytes, including sodium, potassium, calcium, magnesium, phosphate, and chloride.
• Other ingredients: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide, sodium oleate, glacial acetic acid, hydrochloric acid, and water for injections.

Dosage and Administration

1. Smofkabiven Central 986ml Infusion is administered intravenously into a central vein by a healthcare professional.
2. The dose is individualized based on the patient's clinical condition, body weight, and nutritional requirements.
3. For adults, the recommended infusion period is typically 14-24 hours, with an infusion rate not exceeding 2.0 ml/kg body weight/hour.
4. For children aged 2-11 years, the recommended infusion period is 12-24 hours, and the infusion rate should not exceed 2.4 ml/kg body weight/hour.

Storage and Disposal

• Store the medicine in its overpouch below 25°C.
• Do not freeze the product.
• Keep Smofkabiven Central 986ml Infusion out of the sight and reach of children.
• Any unused solution remaining after infusion should be discarded.

Precautions and Safety

• Smofkabiven Central 986ml Infusion requires strict medical oversight due to potential risks.
• Monitor triglyceride levels; they should not exceed 3 mmol/L during infusion.
• Use with caution in patients with impaired lipid metabolism, such as those with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, or sepsis.
• Strict aseptic precautions are essential during catheter insertion and manipulation to prevent infection.
• Regular monitoring of serum glucose, electrolytes, osmolarity, fluid balance, acid-base status, and liver enzyme tests is necessary.
• The infusion must be stopped immediately if any signs of an anaphylactic reaction (e.g., fever, shivering, rash, difficulty breathing) occur.
• Smofkabiven Central 986ml Infusion should not be given simultaneously with blood in the same infusion set.
• This product is not suitable for children younger than 2 years of age.
• In severely malnourished patients, parenteral nutrition should be initiated slowly and carefully to avoid refeeding syndrome, which can cause dangerous shifts in electrolytes.

Side Effects and Risks

• Common side effects may include a slightly raised body temperature.
• Uncommon side effects can include high blood levels of liver compounds, lack of appetite, nausea, vomiting, chills, dizziness, and headache.
• Rare side effects reported are low or high blood pressure, difficulty in breathing, fast heart beat, hypersensitivity reactions (swelling, fever, skin rashes), sensations of hot and cold, paleness, light blue coloured lips and skin, and pain in the neck, back, bones, chest, and loins.
• Serious side effects requiring immediate medical attention include sepsis (infection of the central venous catheter), fat overload syndrome, refeeding syndrome, anaphylactic shock, pulmonary embolism/precipitates, and liver failure.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.