Numeta G19iJu

Adult dosage

The dosage should be determined based on the patient's condition, caloric expenditure, body weight, age, metabolic capacity, and any additional calories or protein supplied orally or via the gastrointestinal tract. The maximum recommended amount should not be exceeded. The maximum infusion rate and daily dosage are as follows: Max infusion rate (mL/kg/hour) 4.6 Max infusion volume (mL/kg/day) 83.6 The undiluted drug can only be administered via central venous route.

This medication should be used cautiously in premature infants and low-birth-weight infants, as it may increase plasma free fatty acid levels, leading to fat accumulation in pulmonary vessels and reported mortality, especially in premature infants with severe respiratory diseases. It should not be administered to patients with allergies to eggs, soybeans, peanuts, or hypersensitivity to any components of this medication. Furthermore, it is contraindicated in patients with congenital amino acid metabolism disorders, those with abnormally high blood levels of sodium, potassium, magnesium, calcium, or phosphorus, severe hyperglycemia, hyperlipidemia, or severe lipid metabolism disorders. In patients with pulmonary edema, heart failure, renal failure, severe hepatic failure, endocrine and metabolic disorders, and severe blood coagulation disorders, close monitoring of fluid balance, electrolyte status, liver function, blood cell counts, etc., is necessary during administration. Care is particularly important if the nutritional supply does not match the patient's needs or if metabolic capacity is uncertain, as metabolic disorders may occur. In clinical trials, adverse reactions such as hypophosphatemia, hyperglycemia, hypercalcemia, hypertriglyceridemia, biliary disorders, and so on have been commonly reported, along with the possibility of skin necrosis or soft tissue damage. Serious side effects such as fat overload syndrome or breathing difficulties due to pulmonary vascular deposits can occur from improper administration. If allergic reactions occur, administration must be stopped immediately, and this medication contains corn-derived glucose, requiring caution in patients allergic to corn. Additionally, this medication should not be administered concurrently with calcium-containing intravenous solutions, as precipitates may form. When using intravenous catheters, there is a risk of infection and sepsis; thus, aseptic techniques and careful catheter management are essential. The possibility of fat overload syndrome and refeeding syndrome must also be considered when adjusting the nutritional supply carefully. This medication must be properly diluted and administered through central veins; peripheral venous administration carries a risk of tissue damage due to extravasation. Blood glucose, electrolytes, liver and kidney function, blood cell counts, and coagulation status should be periodically monitored during administration, and any signs of abnormalities should be addressed immediately. There is insufficient safety data for pregnant and breastfeeding women, so risks and benefits should be carefully evaluated before administration. In the case of overdose, symptoms like vomiting, tremors, electrolyte imbalances, fluid overload, and acidosis may appear, necessitating immediate cessation of administration and proper emergency care. No specific antidote exists, and in severe cases, treatment such as hemodialysis may be required. This medication is for single use only; any unused portion remaining after opening should not be stored. To prevent air embolism during the administration process, bags should not be connected continuously, and the mixed solution should be stored shielded from light.

Serious side effects

In premature and low-birth-weight infants, fat accumulation in the pulmonary vessels and mortality cases due to increased plasma free fatty acid levels; severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor); severe skin reactions (severe rash, blistering, skin peeling, pain of mucous membranes in mouth/eyes accompanied by fever); respiratory problems (shortness of breath or difficulty breathing, asthma attacks, cough with fever).

Mild side effects

• Hypophosphatemia
• hyperglycemia
• hypercalcemia
• hypertriglyceridemia
• hyperlipidemia
• hyponatremia
• biliary disorders
• cholestasis
• extravasation
• tissue damage due to extravasation

This medication should be stored in a sealed container to avoid contact with air, and should be kept in a cool place between 1 and 25 degrees Celsius. It is also important to avoid freezing. Proper storage will help maintain the efficacy of the medication.

Appearance

The amino acid and sugar solutions are transparent liquids that are colorless to slightly yellow, while the fat solution is a homogeneous cloudy liquid, separated into three spaces by two membranes within a single transparent parenteral plastic bag.

Package unit

1000 ml (Amino Acid Solution 392ml, Sugar Solution 383ml, Fat Solution 225ml) / Bag