Anticoagulant and preservative solution for human blood

INSTRUCTIONS for medical use of the medicinal product Anticoagulant and preservative solution for human blood

Composition:

Active substances: 1 l of solution contains sodium citrate 22.0 g, citric acid monohydrate 8.0 g or anhydrous citric acid 7.3 g, glucose monohydrate 24.5 g or anhydrous glucose 22.3 g;

Excipient: water for injections.

Pharmaceutical form. Anticoagulant and preservative solution for blood.

Main physicochemical properties: clear, colorless or pale yellow liquid, free from mechanical particles.

Pharmaco-therapeutic group.

Haematological transfusion aid. ATC code V07A C.

Pharmacological Properties.

Pharmacodynamics.

An anticoagulant and preservative solution for human blood – a sterile, pyrogen-free solution that prevents blood coagulation and provides essential nutrients to enhance metabolism and stabilize cells during blood collection and storage. As with other living systems, the integrity of blood cells during storage depends on the precise biochemical balance of several substances, particularly glucose, hydrogen ions (pH), and adenosine triphosphate (ATP). To maintain continuous ATP production via glycolysis, glucose must be present in sufficient quantity. The amounts of citric acid and sodium citrate are sufficient to bind ionized calcium present in whole blood. Citrate prevents blood coagulation by inhibiting several calcium-dependent steps in the coagulation cascade.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Prevention of clotting of donor blood and storage of blood or its components.

Contraindications.

Blood transfusion with administration of Anticoagulant and preservative solution for human blood is contraindicated in case of hypersensitivity to the components of the medicinal product. Increased bleeding due to disorders of the anticoagulant system.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

There is a risk of complications associated with rapid transfusion of large volumes of blood containing anticoagulant and blood preservative solution in patients with impaired liver or kidney function, or with heart disease (hypokalemia may lead to epileptic seizures and cardiac disturbances). In such cases, serum potassium levels should be closely monitored.

To prevent hypothermia as a complication, blood should be warmed to 37°C using a blood-warming device during transfusion.

The container with solution should be removed from the outer packaging immediately before use.

The container is for single use only; any unused portion should be discarded.

Use only if the solution is clear and the container is undamaged.

After removing the protective overwrap, check the container for leaks by firmly squeezing it for one minute. If leakage is detected, discard the solution, as sterility may be compromised.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is permissible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate when driving or operating machinery.

Patients should refrain from driving or operating machinery during treatment with this medicinal product.

Method of Administration and Dosage.

Do not use the solution for direct intravenous injection!

The solution is intended for use only in plasmapheresis equipment. Blood collection and processing of its components must be performed according to the equipment instructions, strictly observing aseptic techniques. Depending on the type of equipment and blood processing protocol, the blood to Anticoagulant and Blood Preservative Solution ratio ranges from 6.5:1 to 12:1; thus, 8–15 mL of anticoagulant solution should be added per 100 mL of blood.

Preserved donor or autologous erythrocyte concentrate can be stored at a temperature of 2 °C to 6 °C for up to 30 days.

Children.

Due to the lack of experience with the use of this product in children, it should be administered only in exceptional cases, after carefully weighing the benefit/risks ratio.

Overdose.

Not observed.

Side effects.

Immune system disorders: fever, chills.

Allergic reactions: urticaria; however, rarely dyspnea and angioneurotic edema may occur.

Very rare but serious adverse reactions may include anaphylactoid reactions, severe dyspnea, pulmonary edema and/or laryngeal edema, bronchospasm and/or laryngospasm.

Blood and lymphatic system disorders: when blood is administered rapidly or large volumes of blood are transfused, circulatory overload may occur, leading to pulmonary edema. Elderly patients and those with severe chronic anemia are at greatest risk.

Cardiac disorders: rapid infusion of a large volume of cold blood may reduce the patient's body temperature, potentially leading to cardiac arrhythmia and even cardiac arrest.

Nervous system disorders: in isolated cases – paresthesia, mostly around the mouth, as well as muscle twitching, epileptic seizures.

In patients with severe liver or kidney disease, citrate toxicity may occur, reflected by decreased levels of ionized calcium due to the presence of a large amount of citrate anticoagulant in circulation. Rapid administration of citrate-containing blood may quickly reach the heart and provoke ventricular arrhythmia. To detect physiologically significant changes in calcium levels, ECG monitoring and measurement of plasma ionized calcium levels are required.

In patients with impaired circulation or metabolism, acidosis or alkalosis, as well as hyperkalemia or hypokalemia, may occur.

General disorders: rarely – nausea, vomiting; very rarely – headache.

Shelf life.

2 years.

Storage conditions.

Store in a dry, protected from light place at temperature not exceeding 25°C.

Do not overheat! Do not freeze!

Keep out of reach of children.

Incompatibility.

Should not be mixed with other medicinal products.

Use only in plasmapheresis equipment.

Packaging.

250 ml in PVC containers.

40 containers per cardboard box.

Prescription category.

For use only in specialized medical facilities with plasmapheresis equipment.

Manufacturer.

State Enterprise "Farmatreyd"

Manufacturer's address and location of business activity.

82100, Ukraine, Drohobych, Lviv region, Sambirska St., 85.