Medication info

GC Wellbeing Neuramin Solution

Prescription medicationInjectionsApproval withdrawn
Ingredient · strength
L-Isoleucine›0.6775g / 100mLL-Leucine›0.8275g / 100mLL-Lysine Hydrochloride›0.6934g / 100mLL-Methionine›0.045g / 100mLL-Phenylalanine›0.06g / 100mLL-Threonine›0.3375g / 100mLL-Tryptophan›0.0375g / 100mLL-Valine›0.63g / 100mLL-Arginine›0.45g / 100mLL-Histidine›0.1875g / 100mLL-Alanine›0.5475g / 100mLGlycine›0.675g / 100mLL-Proline›0.6g / 100mLL-Serine›0.345g / 100mLAcetylcysteine›0.0337g / 100mL
Manufacturer / importer
(주)녹십자웰빙
Appearance
A colorless to light yellow transparent liquid filled in a colorless or transparent glass vial for injection.
Packaging
100 milliliters/bottle, 200 milliliters/bottle, 250 milliliters/bottle, 500 milliliters/bottle, 1000 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 201907901 · Notified 2019.11.13

This product's status changed to Approval withdrawn on 2024.11.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hepatic encephalopathy due to acute and chronic liver disorder and supply of amino acids
Who uses it
Adults · Children
Adult dosage
The maximum dosage for adults is 1 to 1.5 g of total amino acids per kg of body weight administered intravenously by drip per day. The infusion rate should ideally allow for a total amino acid concentration of about 10 g over 60 minutes, with the principle of a drip rate of 30 to 40 drops per minute.
Children's dosage
In pediatric patients, the dosage and infusion rate should be appropriately adjusted.

Ingredients

Manufacturer
(주)녹십자웰빙

Efficacy & effects

Improvement of hepatic encephalopathy due to acute and chronic liver disorder and supply of amino acids

  • Encephalopathy due to acute and chronic liver disorders
View approved original text

This drug is used to improve encephalopathy caused by acute and chronic liver disorders and to supply the necessary amino acids for patients with impaired liver function.

Dosage and Administration

Adult dosage

The maximum dosage for adults is 1 to 1.5 g of total amino acids per kg of body weight administered intravenously by drip per day. The infusion rate should ideally allow for a total amino acid concentration of about 10 g over 60 minutes, with the principle of a drip rate of 30 to 40 drops per minute.

Children's dosage

In pediatric patients, the dosage and infusion rate should be appropriately adjusted.

Precautions

This drug must be used strictly according to a doctor's instructions. It should not be administered to patients with severe renal impairment or hyperazotemia, patients with metabolic disorders of amino acids other than liver disease, and metabolic disorder patients that have problems with nitrogen utilization. Use should also be avoided in patients with heart failure or pulmonary edema, patients with oliguria or anuria, and in cases where sodium or chloride ions are present, it should not be given to patients with hypernatremia, hyperchloremia, or alkalosis. If magnesium ions are included, it should not be given to patients with atrioventricular block or myasthenia gravis, and caution is needed for patients with fluid overload. Patients with severe acidosis, congestive heart failure, or severe heart failure, patients with edema due to sodium retention, patients with hyperkalemia or potassium retention, and patients with renal impairment should be administered carefully. This medication contains sodium pyrosulfite, which can cause allergic reactions or asthma attacks, so asthmatic patients or those with sulfite sensitivity should exercise caution. Hypersensitivity reactions such as rashes may occur, and if symptoms appear, administration should be immediately discontinued. Gastrointestinal symptoms such as nausea and vomiting, chest discomfort, palpitations, rapid heartbeat, increased blood pressure, chills, fever, headaches, peripheral vascular dilation, metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, osmotic diuresis, dehydration, rebound hypoglycemia, elevated liver enzymes, vitamin deficiencies and excesses, electrolyte imbalances, pediatric hyperammonemia, increased BUN, serum amino acid imbalance, metabolic alkalosis, systemic azotemia, and hyperammonemia may occur. Rapid administration in large amounts can lead to acidosis and even serious symptoms such as chills, fever, headache, respiratory distress, and shock. If magnesium ions are present, peripheral vasodilation may occur. Various metabolic complications such as metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, and dehydration can occur, thus caution is needed. Patients with impaired liver or kidney function should have specific blood levels monitored periodically since levels may rise. When large amounts of this medication are administered or used with electrolyte-containing fluids, careful attention to electrolyte balance is necessary. Excessive administration can cause metabolic alkalosis; therefore, formulations containing acetate ions should be used with caution. Patients with a history of kidney disease, lung diseases, or heart conditions should avoid excessive fluid administration. Diabetic patients should check their blood sugar frequently, and those with hyponatremia or liver and kidney failure should carefully monitor their dosage and manage their fluid and electrolyte status. Interactions may occur when combined with other medications, especially when used with tetracyclines, calcium salts, or vitamin B1, hence caution is required. Pregnant women should only take this medication when the therapeutic benefits outweigh the risks, as its safety has not been established. In children, the dosage should be reduced, and blood ammonia levels should be checked frequently as their liver function may be immature. Elderly patients may have decreased physiological functions, so it is recommended to administer slowly and adjust the dosage accordingly. This drug contains electrolytes, so always check the electrolyte balance during administration, and infusions should be slow. Rapid infusion can cause chills or vomiting and increase the loss of amino acids through the kidneys. Before use, ensure the solution is clear; do not use if the solution is cloudy or discolored. Store in a sealed container to prevent air or moisture from entering, and it is advisable to keep it at a temperature between 1 to 30 degrees Celsius. Proper storage maintains the drug's effectiveness and prevents degradation. The syringe and preparation process must maintain aseptic conditions, and thorough hygiene practices are needed to reduce the risk of infection. It is safer not to use this drug in patients with a history of myocardial infarction.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, asthma attacks, respiratory distress, respiratory failure, shock, bronchospasm, urinary tract spasms, severe edema accompanied by increased blood pressure, jaundice due to liver failure, sudden and very severe headaches, confusion, visual disturbances, paralysis

Mild side effects

  • Rash
  • nausea
  • vomiting
  • chest discomfort
  • palpitations
  • tachycardia
  • increased blood pressure
  • chills
  • fever
  • headache
Show 17 more
  • peripheral vascular dilation
  • metabolic acidosis
  • hypophosphatemia
  • alkalosis
  • hyperglycemia
  • diabetes
  • osmotic diuresis and dehydration
  • rebound hypoglycemia
  • elevated liver enzymes
  • vitamin deficiencies and excesses
  • electrolyte imbalances
  • pediatric hyperammonemia
  • increased BUN
  • serum amino acid imbalance
  • metabolic alkalosis
  • systemic azotemia
  • hyperammonemia

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

A colorless to light yellow transparent liquid filled in a colorless or transparent glass vial for injection.

Package unit

100 milliliters/bottle, 200 milliliters/bottle, 250 milliliters/bottle, 500 milliliters/bottle, 1000 milliliters/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.