Medication info

Biosol F Injection

Prescription medicationInjections
Ingredient · strength
L-Isoleucine›384mg / 100mLL-Leucine›645mg / 100mLL-Lysine Acetate›599.4mg / 100mLL-Methionine›258mg / 100mLAcetylcysteine›51.78mg / 100mLL-Phenylalanine›274mg / 100mLL-Threonine›309mg / 100mLL-Tryptophan›110mg / 100mLL-Valine›425mg / 100mLL-Arginine›384mg / 100mLL-Histidine›248mg / 100mLGlycine›248mg / 100mLL-Alanine›430mg / 100mLL-Proline›971mg / 100mLL-Serine›542mg / 100mLN-Acetyl-L-Tyrosine›405mg / 100mL
Manufacturer / importer
한올바이오파마(주)
Appearance
A colorless to pale yellow transparent solution in a colorless transparent glass vial sealed with a rubber stopper for injection.
Packaging
250 milliliters per bottle
Approval status
Active

MFDS item code 202300488 · Notified 2023.02.08

Summary

Main use
Improvement of hypoproteinemia and undernutrition
Who uses it
Adults · Children
Adult dosage
Adults: Administer intravenously by infusion at a maximum dosage of 1 to 1.5 g of total amino acids per kg of body weight per day. Infusion rate: A concentration of approximately 10 g of total amino acids over 60 minutes is desirable, and it is recommended to infuse at a rate of 30-40 drops per minute.
Children's dosage
For pediatric patients, dosage and infusion rates should be adjusted accordingly.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Improvement of hypoproteinemia and undernutrition

  • Hypoproteinemia
  • undernutrition
View approved original text

Amino acid supplementation is used to maintain protein balance in the body and aid recovery in conditions such as hypoproteinemia, undernutrition, and pre-and post-operative states.

Dosage and Administration

Adult dosage

Adults: Administer intravenously by infusion at a maximum dosage of 1 to 1.5 g of total amino acids per kg of body weight per day. Infusion rate: A concentration of approximately 10 g of total amino acids over 60 minutes is desirable, and it is recommended to infuse at a rate of 30-40 drops per minute.

Children's dosage

For pediatric patients, dosage and infusion rates should be adjusted accordingly.

Precautions

This medication must be used strictly according to a doctor's instructions. It should not be administered to patients with hepatic coma or those at risk of hepatic coma, patients with severe renal impairment or hypernitrogenemia, or individuals with metabolic disorders affecting nitrogen usage. Additionally, it should not be used in patients with wasting cardiac failure, pulmonary edema, oligoanuria or anuria, hypernatremia and hyperchloremia or alkalosis, patients with atrioventricular block or severe myasthenia gravis, those receiving excessive fluid, or patients with acidosis. In patients with congestive heart failure, edema due to sodium retention, hyperkalemia or potassium retention, and those with liver or kidney dysfunction, it should be administered with caution. Rarely, hypersensitivity reactions such as rash may occur while using this medication, in which case it should be stopped immediately. Gastrointestinal symptoms such as nausea or vomiting, thoracic discomfort, palpitations, tachycardia, and increased blood pressure may occur. Rapid massive administration can lead to acidosis, requiring careful attention. Occasionally, serious side effects such as chills, fever, headache, dyspnea, respiratory arrest, shock, bronchospasm, and urinary colic may occur. Symptoms of peripheral vascular dilation may also be observed, necessitating caution. Various metabolic complications such as metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, dehydration, hypoglycemia, elevated liver enzymes, vitamin deficiencies or excesses, electrolyte imbalances, and hyperammonemia in children may arise. Patients with poor liver or kidney function may experience elevated blood urea nitrogen (BUN) levels. Patients with severely impaired liver function are at risk of serum amino acid imbalance, metabolic alkalosis, systemic nitrogen saturation, hyperammonemia, and coma. When given in large doses or in conjunction with electrolyte-containing solutions, attention must be paid to electrolyte balance. Excess dosage can cause metabolic alkalosis, so preparations containing acetate ions should be used cautiously. Patients with kidney disease, lung disease, or severe heart disease should be careful to avoid fluid overload. Diabetic patients should regularly monitor their blood glucose levels while using this medication. There are interactions with other medications; particularly, the protein-sparing effect may be reduced when used with tetracycline antibiotics, and intravenous calcium salts may precipitate magnesium. The safety for pregnant women has not been established, so it should only be administered when the therapeutic benefit outweighs the risks. In children, since liver function may be immature, the dosage concentration should be kept low, and blood ammonia levels should be checked frequently. Elderly patients often have decreased bodily functions, so the administration rate should be slower and the dosage should be reduced. This medication contains electrolytes; thus, care must be taken with electrolyte balance during massive administration, and it should be infused slowly intravenously. Rapid infusion may cause chills or vomiting, and losses of amino acids through the kidneys may increase. In colder conditions, the medication should be warmed to body temperature before use, and strict aseptic conditions must be maintained during administration. Do not use the solution if it is cloudy, discolored, or if there are defects in the packaging. When storing, soft bag products do not require venting, while vial products need to be vented just prior to use. Do not use if the solution is leaked or if there are droplets on the packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, respiratory distress, respiratory arrest, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly decreased urine output, severe generalized swelling accompanied by increased blood pressure.

Mild side effects

  • Rash
  • nausea
  • vomiting
  • thoracic discomfort
  • palpitations
  • tachycardia
  • increased blood pressure
  • acidosis
  • chills
  • fever
Show 18 more
  • headache
  • shock
  • bronchospasm
  • urinary colic
  • 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
  • elevated BUN
  • serum amino acid imbalance.

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

Storage

This medication should be stored in a sealed container to avoid contact with air and should ideally be stored at room temperature between 1°C and 30°C. This helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

A colorless to pale yellow transparent solution in a colorless transparent glass vial sealed with a rubber stopper for injection.

Package unit

250 milliliters per 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.

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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.