Duozhen Medium and Long Chain Fat Emulsion Amino Acids (16) and Glucose (36%) Injection

1. Indications and Usage
Parenteral Nutrition: For adult and pediatric patients (≥2 years) with moderate to severe catabolism who cannot take or tolerate oral/enteral nutrition.
Metabolic Support: Provides energy, essential fatty acids, and amino acids required for protein synthesis and metabolic homeostasis.
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Adults: Maximum daily dose is 35-40 mL/kg (approx. 1.28-2.0 g amino acids/kg, 2.56-5.04 g glucose/kg, 1.4-1.6 g fat/kg).
Pediatrics: Dosage varies by age (e.g., 2-4 years: 25 mL/kg; 5-13 years: 17.5-30 mL/kg).
Critical Administration Instructions:
Mixing: This is a triple-chamber bag; squeeze to mix the three compartments (Fat Emulsion, Amino Acids, and Glucose) before hanging.
Infusion Rate: Start slowly for the first 30 minutes. The maximum infusion rate is generally 1.7 to 2.5 mL/kg/hour.
Filtration: Use a 1.2 μm inline filter is recommended during infusion.
3. Mechanism of Action
Energy Supply: Glucose provides rapid energy; medium-and-long chain triglycerides (MCT/LCT) offer a balanced energy source with efficient metabolism and reduced organ deposition.
Nitrogen Source: Amino acids (16-type) supply essential and non-essential amino acids to support muscle protein synthesis and prevent catabolism.
4. Safety and Warnings
Contraindications: Severe lipid metabolism disorders, severe liver or renal dysfunction, acute shock, decompensated heart failure, and known hypersensitivity to egg or soybean protein.
Hyperglycemia: High glucose concentration requires careful blood glucose monitoring; may need exogenous insulin.
Hyperlipidemia: Serum triglycerides must be monitored and should not exceed 3 mmol/L during infusion.
DEHP Leaching: Avoid using PVC tubing containing DEHP to prevent plasticizer leaching into the lipid emulsion.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Fat overload syndrome (fever, hepatosplenomegaly, anemia), hyperglycemia, electrolyte imbalances, and infusion site reactions (phlebitis).
Hypersensitivity: Rare cases of anaphylactic shock, rash, and dyspnea have been reported.
Clinical Research Highlights: Clinical studies demonstrate that this triple-chamber formulation effectively maintains nitrogen balance and improves clinical outcomes in catabolic patients.
6. Drug Interactions
Electrolytes and Vitamins: Compatible with standard parenteral nutrition additives (electrolytes, vitamins, trace elements) when prepared according to compatibility guidelines.
Heparin: May cause brief release of lipoprotein lipase, leading to transient changes in fat clearance.
Insulin: May interfere with the body’s lipase system; blood glucose monitoring is essential.
7. Pharmaceutical Information
Chemical Composition: Active Ingredients: Medium-and-long chain fat emulsion, Amino Acids (16), and Glucose (36%).
Appearance: The mixed composite injection is a white or off-white milky emulsion.
Packaging: Triple-chamber bag (e.g., 625 mL or 1250 mL per bag).
Storage: Store at controlled room temperature (usually ≤25°C). Once mixed, it can be stored at 2-8°C for up to 24 hours.