Gelatinol (Solution) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

B05AA06 (Gelatin preparations)

Active Substance

Gelatin (Ph.Eur. European Pharmacopoeia)

Dosage Form

Gelatinol

Infusion solution (in sodium chloride 0.9% solution) 8 g/100 ml: fl. 450 ml 15 pcs.

Dosage Form, Packaging, and Composition

450 ml – blood substitute bottles (15) – cardboard boxes.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Gelatinol is a hypertonic colloidal solution and has an anti-shock effect.

The therapeutic effect of Gelatinol is associated with the high colloid-osmotic pressure (220-290 mm H2O) it creates in the lumen of the blood vessels.

The increase in circulating plasma volume (more than 1.5 times the initial value) and the increase in blood pressure occur not only due to the administered solution but also due to the additional influx of interstitial fluid into the vascular bed.

Gelatinol increases the erythrocyte sedimentation rate, which normalizes on average by the 20th day; it does not impair the protein, carbohydrate, and pigment functions of the liver and improves microcirculation.

Pharmacokinetics

Gelatinol rapidly leaves the bloodstream, which is explained by the presence of a large number of low-molecular fractions (after 2 hours, about 20% of the administered drug remains in the blood).

The main part of the drug is excreted from the body by the kidneys (about 40% of the drug on the first day, 1% on the second).

The remaining part penetrates from the vascular bed into the tissues, where it is exposed to tissue enzymes – proteases and is included in protein metabolism.

Indications

• As a plasma-substituting agent in the treatment of shock (traumatic, burn, hemorrhagic, and toxic of 1-2 degree);
• For filling the artificial circulation apparatus;
• For detoxification in burns and other conditions accompanied by intoxication.

ICD codes

Dosage Regimen

The drug is administered intravenously or intra-arterially, regardless of blood group.

In acute blood loss and shock, rapid intravenous injection is recommended, followed by a switch to drip infusion (50-60 drops per minute) to maintain blood pressure at a physiological level.

The dose of the drug depends on the patient’s condition.

If necessary, Gelatinol may be prescribed repeatedly.

No more than 2 liters of solution can be administered simultaneously.

For children – at a dose of no more than 15-25 mg/kg of body weight.

For extracorporeal circulation, Gelatinol is used together with donor erythrocytes in various ratios and with the addition of other solutions.

Adverse Reactions

Albuminuria (for 1-2 days after administration).

In very rare cases, allergic reactions of varying severity may occur.

It should be borne in mind the danger of developing anaphylactic shock in patients at risk, with a history of drug intolerance, including sera, vaccines, as well as intravenous infusions of protein preparations, plasma-substituting drugs, including dextran preparations.

If adverse reactions occur, the infusion should be stopped immediately and, without removing the needle from the vein, administer antihistamines, vasoconstrictors and glucocorticosteroids, vasopressor agents used in the treatment of anaphylactic shock.

Contraindications

• Hypersensitivity to the drug;
• Acute and chronic nephritis.

Use in Renal Impairment

The drug is contraindicated in patients with acute and chronic nephritis.

Special Precautions

Before transfusion of Gelatinol, the physician should visually inspect the bottles intended for infusion.

The drug is considered suitable for use provided the closure integrity is maintained and there are no cracks on the bottles.

The drug must be transparent and free of suspension.

The results of the visual inspection of the bottles and the label data (drug name, manufacturer, batch number) must be recorded in the patient’s medical history.

When using Gelatinol, a biological test must be performed: after the first 5 drops are administered, the infusion is stopped for 3 minutes, then another 30 drops are administered and the infusion is stopped again for 3 minutes; if no adverse reaction occurs, the administration of the drug is continued.

The test results must be recorded in the medical history.

Drug Interactions

It is compatible with nitrogen-containing preparations for parenteral nutrition, vitamins, glucose solution in various ratios, blood and its components.

Storage Conditions

Store at 8°C (46°F) to 15°C (59°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.