Medication info

Amiserfol Injection

Prescription medicationInjections
Ingredient · strength
L-Isoleucine›1.04g / 100mLL-Leucine›1.309g / 100mLL-Lysine Acetate›0.971g / 100mLL-Methionine›0.11g / 100mLAcetylcysteine›0.07g / 100mLL-Phenylalanine›0.088g / 100mLL-Threonine›0.44g / 100mLL-Tryptophan›0.07g / 100mLL-Valine›1.008g / 100mLL-Arginine›1.072g / 100mLL-Histidine›0.28g / 100mLGlycine›0.582g / 100mLL-Alanine›0.464g / 100mLL-Proline›0.573g / 100mLL-Serine›0.224g / 100mL
Manufacturer / importer
삼성제약(주)
Appearance
An injection filled in a colorless transparent glass container with a colorless transparent solution
Packaging
100 mL/bottle, 250 mL/bottle
Approval status
Active

MFDS item code 200710940 · Notified 2007.10.01

Summary

Main use
Treatment of severe liver dysfunction and hepatic coma
Who uses it
Adults
Adult dosage
Generally administered as a maximum intravenous infusion of 1.5 g per kg of body weight per day as total amino acids (for a body weight of 70 kg, this corresponds to 1300 mL per day). The administration rate should be a maximum of 1.25 mL per kg over 60 minutes.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Treatment of severe liver dysfunction and hepatic coma

  • Brain function impairment
  • severe liver dysfunction
  • hepatic coma
View approved original text

This medication is used for the treatment of severe liver dysfunction, particularly when accompanied by or without brain function impairment, and hepatic coma. It helps provide necessary nutrition in situations where liver function is significantly impaired, protects brain function, and alleviates symptoms of hepatic coma. Therefore, it effectively improves liver health and neurological function in cases of liver disease or related symptoms.

Dosage and Administration

Adult dosage

Generally administered as a maximum intravenous infusion of 1.5 g per kg of body weight per day as total amino acids (for a body weight of 70 kg, this corresponds to 1300 mL per day). The administration rate should be a maximum of 1.25 mL per kg over 60 minutes.

Precautions

This medication must be used strictly according to a doctor's instructions, and should not be taken or administered based on personal judgment. It should not be used in patients with poor kidney function or high blood nitrogen levels, nor in individuals with amino acid metabolic disorders related to liver dysfunction. In addition, patients with metabolic disorders that make nitrogen utilization difficult, those with weak heart function, patients with pulmonary edema, and patients with severely impaired kidney function may also be at risk when using this medication. It should not be administered to patients with acidosis, those who have been excessively hydrated, patients with a history of myocardial infarction, those with low blood sodium levels, or those in shock or lacking oxygen supply. Patients with edema due to sodium retention or those with a history of kidney disease, lung disease, heart disease, and diabetics should use this medication with caution. It may cause allergic reactions, so special caution is required for asthmatics. This medication can rarely cause hypersensitivity reactions such as skin rashes, so if any abnormal symptoms occur, administration should be stopped immediately. Gastrointestinal symptoms may include nausea or vomiting, while cardiovascular symptoms may include chest discomfort, palpitations, rapid pulse, and elevated blood pressure. Administration in large quantities or rapidly can lead to acidosis, indicating the need for caution. Additionally, various side effects may occur, including chills, fever, headache, difficulty breathing, shock, bronchial constriction, and urinary tract spasms. Metabolic abnormalities such as acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, dehydration, and imbalances in vitamin levels due to liver dysfunction should be monitored. In patients with kidney failure, blood urea nitrogen (BUN) levels can rise, and serum ammonia levels may vary according to treatment effects, necessitating regular examinations. When this medication is administered in large amounts or used with other electrolyte-containing solutions, careful observation of electrolyte balance is necessary, especially since overload can lead to metabolic alkalosis. Care should be taken with patients having kidney disease, lung disease, or severe heart disease to avoid excessive fluid volume. Diabetic patients should frequently check blood glucose levels, and regular monitoring of blood electrolytes, fluid balance, acid-base balance, blood glucose, serum proteins, creatinine, and liver function is required. When administered via peripheral veins, it is advisable to frequently check the injection site to reduce the risk of thrombophlebitis. This medication may reduce the protein-sparing effect when used in combination with specific antibiotics, so it is essential to inform the doctor of any concurrent medications. Moreover, due to the risk of microbial contamination, this medication should not be mixed with other treatments and should only be combined with non-oral nutrition products. For women who are pregnant or breastfeeding, the safety of this medication has not been established; it should only be used if the doctor deems the therapeutic benefit to outweigh the risk. When administering to children, concentrations should be reduced due to potential immature liver function, and blood ammonia levels should be frequently checked for abnormalities. Elderly patients may have reduced bodily functions, so caution is needed to administer at a slow rate and reduce the dosage. This medication contains electrolytes, so attention should be given to electrolyte balance during large doses, and it should be slowly infused intravenously, as rapid infusion can cause chills or vomiting. Furthermore, the medication should be administered close to body temperature, and preparation and management should be conducted under aseptic conditions to reduce infection risk. Do not use if the solution is cloudy or discolored, and any remaining solution should be promptly discarded, ensuring use within 24 hours if stored in the refrigerator. When storing, do not open the packaging, and do not use if there are any leaks or abnormalities in the packaging. Also, avoid use if the cap is damaged and ensure accurate measurement of the container scale for administration.

Side effects and when to seek care immediately

Serious side effects

Difficulty breathing, respiratory arrest, shock, bronchial constriction (corresponding to severe allergic reactions and respiratory problems)

Mild side effects

  • Rarely, symptoms of hypersensitivity such as rash
  • Nausea, vomiting
  • Chest discomfort, palpitations, rapid pulse, elevated blood pressure
  • Acidosis with rapid large doses
  • Chills, fever, headache
  • Urinary tract spasms
  • Metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, osmotic diuresis and dehydration, rebound hypoglycemia, liver enzyme elevation, vitamin deficiency and excess, electrolyte imbalance
  • Elevation of BUN
  • Changes in serum ammonia levels

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

Storage

This medication should be stored in a sealed container to prevent contact with air, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Storing it this way will help preserve the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

An injection filled in a colorless transparent glass container with a colorless transparent solution

Package unit

100 mL/bottle, 250 mL/bottle

Same-ingredient medicines

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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.

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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.