Relbinor^® (Solution) Instructions for Use

Marketing Authorization Holder

Amedart LLC (Russia)

ATC Code

B05XA16 (Cardioplegic solutions)

Dosage Forms

	Relbinor®	Solution for perfusion 500 ml
		Solution for perfusion 1000 ml
		Solution for perfusion 2000 ml
		Solution for perfusion 5000 ml

Dosage Form, Packaging, and Composition

Solution for perfusion

500 ml – bags (10 pcs.) – cardboard boxes – for hospitals

Solution for perfusion green.

1000 ml – bags (6 pcs.) – cardboard boxes – for hospitals

Solution for perfusion

2000 ml – bags (4 pcs.) – cardboard boxes – for hospitals

Solution for perfusion

5000 ml – bags (2 pcs.) – cardboard boxes – for hospitals

Clinical-Pharmacological Group

Cardioplegic agent

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; electrolyte solutions; cardioplegic solutions

Pharmacological Action

It prolongs organ resistance to hypoxia through two main mechanisms: (1) the electrolytes included in this agent provide a blockade of the initiation of energy-consuming processes, reducing the organ’s energy requirements to a minimum level; (2) the histidine buffer inhibits glycolysis, which leads to the formation of lactic acid, slows down the decrease in pH in tissues that occurs under conditions of organ ischemia and causes an increase in the proportion of energy released via the anaerobic mechanism during glycolysis.

It provides effective protection of the heart from ischemic damage under conditions of general moderate hypothermia lasting up to 180 minutes after a single administration, as well as protection of human organs during their transplantation.

Potassium alpha-ketoglutarate participates in oxidative processes with energy release during the initial stages of cardioplegia and upon resumption of cardiac activity.

Tryptophan contributes to the protection of cell membranes from destruction.

Mannitol protects cells from edema.

The osmolality of this agent is somewhat lower than the osmolality of blood plasma and the intracellular space.

Depending on the type and duration of the surgical operation, the methodological features of its performance, and the patient’s body weight, the volume of this solution entering the blood circulation system can range from 100 ml to 3.0 L.

Pharmacokinetics

Potassium ketoglutarate is metabolized mainly in the citric acid cycle.

Mannitol, being practically non-metabolized, is excreted by the kidneys.

Within the first 24 hours after the application of this solution, the concentrations of tryptophan and histidine may be elevated compared to normal values, but these amino acids are metabolized quite rapidly – predominantly in the liver, but are also excreted by the kidneys.

Indications

Cardiac surgery under conditions of cold cardioplegia using a heart-lung machine; protection of the heart from ischemic damage; protection of donor organs (kidneys, liver, heart, lungs, pancreas) from ischemia during transplantation; preservation of transplantable organs; storage of venous and arterial grafts.

ICD codes

Dosage Regimen

Administer this cardioplegic solution exclusively in a hospital setting under direct medical supervision.

Use only for perfusion during cardiac surgery or organ preservation; it is not for intravenous or intra-arterial injection.

Select the solution volume (500 ml, 1000 ml, 2000 ml, or 5000 ml) based on the patient’s body weight, the type and duration of the surgical procedure, and specific methodological requirements.

For cardiac surgery using a heart-lung machine, administer as a single dose to induce cold cardioplegia and provide myocardial protection for up to 180 minutes under general moderate hypothermia.

For organ transplantation, use the solution for the protection, preservation, and storage of donor organs, including the heart, lungs, liver, kidneys, and pancreas, as well as for venous and arterial grafts.

Adjust the total administered volume, which can range from 100 ml to 3.0 liters, according to the clinical situation and the patient’s individual characteristics.

Strictly adhere to aseptic techniques when connecting the solution bag to the perfusion system.

Adverse Reactions

No adverse reactions have been detected.

Contraindications

Hypersensitivity to the active substances included in the used drug.

Use in Pregnancy and Lactation

It is not recommended for use during pregnancy and breastfeeding.

Use is possible if the benefit to the mother outweighs the potential risk to the fetus.

Use in Hepatic Impairment

Approved for use in patients with impaired liver function.

Use in Renal Impairment

Approved for use in patients with impaired renal function.

Pediatric Use

Approved for use in children and adolescents under 18 years of age

Geriatric Use

Approved for use in elderly patients

Special Precautions

The solution is not intended for intravenous or intra-arterial administration.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.