Medication info

Custodial Solution

Prescription medicationSolution주사
Ingredient · strength
Tryptophan›40.85mg / 100mLHistidine›2792.89mg / 100mLL-Histidine Hydrochloride›377.33mg / 100mLPotassium Hydrogen 2-Ketoglutarate›18.42mg / 100mLMagnesium Chloride›81.32mg / 100mLMannitol›546.51mg / 100mLCalcium Chloride›0.22mg / 100mLPotassium Chloride›67.1mg / 100mLSodium Chloride›87.66mg / 100mL
Manufacturer / importer
(주)제니스팜
Appearance
A pale yellow transparent solution
Packaging
6 packs/box [(1000ml/pack)], 2 packs/box [(5000ml/pack)]
Approval status
Active

MFDS item code 200511666 · Notified 2005.05.13 · Insurance code 660300030,660300040

Summary

Main use
Cardioprotection, liver and kidney protection (organ protection and surface cooling), and protection of vascular grafts
Who receives it
Adults
Adult administration
1) Heart For adults, this medication should be cooled to 5 ~ 8 ℃ and administered via hydrostatic pressure (the initial height of the bag should be placed 140 cm above the heart - 100 mmHg) or given in a consistent amount by a pump for coronary artery infusion. After cardiac arrest (within the first minute after the start of infusion), the height of the bag should be lowered to 50 ~ 70 cm above the heart to achieve a pressure of 40 ~ 50 mmHg.

Ingredients

Importer
(주)제니스팜

Efficacy & effects

Cardioprotection, liver and kidney protection (organ protection and surface cooling), and protection of vascular grafts

  • Cardiac arrest
View approved original text

This medication is used to prevent cardiac arrest that may occur during heart surgery, to protect organs during transport from organ donors to recipients, and for surface cooling during in-situ organ surgeries. It is also used to protect vascular grafts such as in coronary artery bypass surgery. For these purposes, this medication helps reduce organ damage during surgeries and improves transplant success rates.

How it is given

Adult administration

1) Heart For adults, this medication should be cooled to 5 ~ 8 ℃ and administered via hydrostatic pressure (the initial height of the bag should be placed 140 cm above the heart - 100 mmHg) or given in a consistent amount by a pump for coronary artery infusion. After cardiac arrest (within the first minute after the start of infusion), the height of the bag should be lowered to 50 ~ 70 cm above the heart to achieve a pressure of 40 ~ 50 mmHg.

Precautions

This medication should not be used for direct injection into veins or arteries. It is to be used only when the heart has stopped or for selective perfusion of the kidneys and liver, and for the purpose of cooling organ surfaces during the transport of organs from donors to recipients or preserving vascular grafts. This medication should never be used for systemic circulation, as it is not suitable for that purpose. There have been no reported adverse reactions in human or animal studies, clinical trials, or academic literature related to this medication, and no adverse reactions associated with it were found in a domestic survey conducted on 716 people over six years. However, since the components of this medication may alter electrolyte concentrations in the bloodstream when it enters systemic circulation, it is essential to carefully monitor calcium, sodium, potassium, and magnesium levels and adjust as necessary. It should be stored out of reach of children and is not suitable for replenishing systemic circulation or as an amino acid and electrolyte substitute. No interactions have been reported with some medications used during surgery or hospitalization, but caution should be exercised. Since there is no experience using this medication in pregnant or breastfeeding women, the risks and benefits should be carefully evaluated, and in emergencies, efforts should be made to ensure that it is completely eliminated from the heart. This medication should not be mixed with other drugs, and especially when used on the heart, the solution must be adequately cooled. Improper cooling may lead to a phenomenon known as calcium paradox, which can result in damage to cardiac muscle cells.

Storage

This medication should be stored in a cool place away from direct sunlight, at a temperature between 8 to 15 degrees Celsius. This helps safely maintain the efficacy of the medication.

Appearance and packaging

Appearance

A pale yellow transparent solution

Package unit

6 packs/box [(1000ml/pack)], 2 packs/box [(5000ml/pack)]

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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.