Medication info

Tetraspan Injection 10%

Prescription medicationApproval withdrawn
Ingredient · strength
Hydroxyethyl Starch›Strength being verifiedSodium Chloride›Strength being verifiedPotassium Chloride›Strength being verifiedCalcium Chloride Hydrate›Strength being verifiedMagnesium Chloride Hexahydrate›Strength being verifiedSodium Acetate Hydrate›Strength being verifiedMalic Acid›Strength being verified
Manufacturer / importer
비브라운코리아(주)
Appearance
A colorless to slightly yellow transparent liquid in a colorless transparent polyethylene plastic container or colorless transparent plastic bag (plastic bag made of Nexcel pharmaceutical M312 film) for injection
Packaging
Bag - 500 milliliters/bag
Approval status
Approval withdrawn

MFDS item code 200903975 · Approved 2009.06.08

This product's status changed to Approval withdrawn on 2023.07.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of blood volume reduction and effective rapid hemodilution therapy
Who uses it
Adults
Adult dosage
Administer by intravenous drip, initially infusing 10-20 mL while closely monitoring the patient. Daily dose and infusion rate are determined based on the amount of blood loss, maintenance or restoration of hemodynamic parameters, and blood dilution, and may be repeated over several days depending on the condition. The duration of administration is determined based on the duration and degree of blood volume reduction, hemodynamic effects, and blood dilution. The maximum daily dose is 30 mL per kg of body weight.

Ingredients

Importer
비브라운코리아(주)

Efficacy & effects

Treatment and prevention of blood volume reduction and effective rapid hemodilution therapy

  • Blood volume reduction
View approved original text

This medication is used to treat and prevent blood volume reduction when other treatments are not appropriate. It is also applicable for rapid normovolemic hemodilution (ANH) to improve the patient's condition.

Dosage and Administration

Adult dosage

Administer by intravenous drip, initially infusing 10-20 mL while closely monitoring the patient. Daily dose and infusion rate are determined based on the amount of blood loss, maintenance or restoration of hemodynamic parameters, and blood dilution, and may be repeated over several days depending on the condition. The duration of administration is determined based on the duration and degree of blood volume reduction, hemodynamic effects, and blood dilution. The maximum daily dose is 30 mL per kg of body weight.

Precautions

This drug may increase the risk of mortality, kidney damage, and excessive bleeding, so it should only be used when other treatment options are inappropriate. It is not safe to use in patients with sepsis, kidney damage, or severe conditions. In patients with hypovolemia who are at risk for renal or hepatic dysfunction, careful evaluation is required, and the use of colloids should be prioritized. Additionally, when administering this drug with calcium-containing intravenous preparations, precipitate may form, so different infusion apparatus should be used, and the infusion line must be thoroughly cleaned. It should not be administered to specific patient populations, such as those with severe liver disease, heart failure, coagulation disorders, dehydration, and those undergoing dialysis. In neonates, particularly when used in combination with ceftriaxone, it should not be co-administered due to risks. Dose adjustment and careful administration are necessary in patients with a history of liver disease or coagulation disorders, severe dehydration, and compromised kidney and liver function. This drug can rarely cause allergic reactions or side effects such as itching, coagulation abnormalities, headache, and vomiting, so careful monitoring should be conducted during administration. In case of overdose, circulatory overload may occur, so especially in heart failure patients, the dose must be adjusted, and serum electrolytes and kidney function should be regularly checked. If severe allergic reactions such as anaphylaxis occur, administration should be stopped immediately, and emergency treatment should be provided. Do not mix this drug with other medications, and use immediately after opening; any remaining drug should be discarded. During pregnancy, the risks to the fetus and therapeutic benefits must be carefully considered before use, and safety data regarding lactating women is unavailable. During administration of this drug, caution should be exercised as it may affect pancreatic disease diagnosis in blood tests. In cases of overdose, signs of circulatory overload such as pulmonary edema may occur, so administration must be stopped immediately, and appropriate treatment should be provided as needed. This drug is for intravenous use only, and should be stored below 25 degrees Celsius without freezing and out of reach of children. Before use, ensure that the solution is clear and the packaging is intact, and do not use products that have expired.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
  • Coagulation disorders → severe swelling or urinary abnormalities
  • Pulmonary edema → respiratory problems
  • Circulatory overload and pulmonary edema due to overdose
  • Severe coagulopathy such as thrombocytopenia and hemophilia
  • Severe kidney damage
  • Anaphylactic reaction
  • In case of anaphylaxis reaction during infusion, discontinue immediately and provide emergency care

Mild side effects

  • Influenza-like symptoms
  • bradycardia
  • tachycardia
  • bronchospasm
  • non-cardiogenic pulmonary edema
  • rash
  • itching
  • vomiting
  • chills
  • fever
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  • headache
  • increased serum α-amylase concentration

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

Storage

This drug should be stored in a sealed container at temperatures between 1 and 30 degrees Celsius to prevent freezing. Therefore, it is important not to keep it in too cold or too hot places.

Appearance and packaging

Appearance

A colorless to slightly yellow transparent liquid in a colorless transparent polyethylene plastic container or colorless transparent plastic bag (plastic bag made of Nexcel pharmaceutical M312 film) for injection

Package unit

Bag - 500 milliliters/bag

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.