TRISOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRISOL (TRISOL)

Composition:

Active substances: sodium chloride, potassium chloride, sodium bicarbonate;

1 ml of solution contains 5 mg of sodium chloride, 1 mg of potassium chloride, 4 mg of sodium bicarbonate;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid;

ionic composition per 1000 ml of the product: Na+ – 133.16 mmol, K+ – 13.41 mmol, Cl¯ – 98.96 mmol, HCO3¯ – 48.42 mmol;

theoretical osmolarity 293 mOsm/L; pH 8.1–8.9.

Pharmacotherapeutic group. Solutions used for correction of electrolyte balance disorders. Electrolytes. ATC code B05B B01.

Pharmacological Properties

Pharmacodynamics

An electrolyte plasma-substituting solution exerting a detoxifying effect. Prevents blood thickening and the development of metabolic acidosis, reduces hypovolemia, improves microcirculation, and the functional state of the heart and kidneys, enhances diuresis.

Pharmacokinetics

The drug remains in the vascular bed for a short period, rapidly passing into the interstitial space. It is excreted by the kidneys, enhancing diuresis.

Clinical characteristics.

Indications.

Correction of fluid and electrolyte imbalances in acute intestinal infections and other conditions caused by isotonic and hypotonic dehydration and intoxication of various origins.

Contraindications.

Hypersensitivity, hyperkalemia, hypernatremia, severe renal and/or cardiac insufficiency, hyperhydration, cerebral or pulmonary edema, metabolic alkalosis, impaired renal excretory function or risk of its development.

Interaction with other medicinal products and other types of interactions.

No adverse effects have been observed in interactions with other medicinal products, except for those incompatible with sodium chloride as a solvent.

Special precautions.

Before use, warm the solution to 36–38°C. Monitor laboratory parameters of electrolyte balance during administration. If hyperkalemia develops, replace Trisol with Disol until electrolyte balance is normalized. Assess the balance between fluid loss and administered Trisol solution every 6 hours. The total volume of infused solution should correspond to the degree of dehydration.

Use during pregnancy or breastfeeding.

There is no experience with the use of this medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Data on the effect of the medicinal product on the ability to drive vehicles or operate machinery are lacking, as the drug is used exclusively under inpatient conditions.

Administration and Dosage.

Trisol solution is administered intravenously either as a bolus or by drip infusion. Before administration, warm the solution to 36−38°C. In severe forms of pathological conditions, administer initially as a bolus, followed by intravenous drip infusion (40−120 drops per minute over 24−48 hours). In emergency rehydration therapy for hypovolemic shock, administer Trisol solution as a bolus infusion over 1−3 hours. The total volume administered should correspond to the volume of fluid lost. However, during the first hour, the volume administered should typically equal 7−10% of body weight.

The drug should be used under monitoring of laboratory parameters and hemodynamic status. The maximum daily dose is 3 L.

In children, the solution is administered intravenously (bolus or drip) in volumes necessary to restore lost fluid volume.

Children.

Trisol, infusion solution, should be administered to children under medical supervision in emergency conditions based on vital indications.

Overdose.

Hyperkalemia, hypernatremia, hyperhydration, alkalosis.

Administration of large volumes of the solution may lead to impaired kidney function, hypervolemia, hyperkalemia (paresthesia, confusion, paralysis, sudden cardiac arrest), hypernatremia, alkalosis, hyperhydration, and cerebral edema.

Treatment. Discontinue administration and initiate symptomatic therapy: administration of glucose solutions, sodium bicarbonate-containing solutions, calcium. Remove the drug via hemodialysis. Hyperkalemia is managed by preventing hypercatabolism, discontinuing potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, heparin, and beta-blockers, and avoiding dietary potassium and potassium-containing medications. Hyperhydration is managed by administering diuretics: high doses of furosemide (up to 100 mg per day parenterally) with continuous monitoring of electrolyte levels.

Side effects.

Hypersensitivity reactions and dyspeptic disorders may occur in case of individual intolerance to any component of the drug.

Hyperkalemia, hypernatremia, alkalosis, hypervolemia, hyperhydration.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging.

200 ml and 400 ml in glass bottles.

Prescription status. Prescription only.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.