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Trisol (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substances

Sodium chloride (Ph.Eur.)

Potassium chloride (Ph.Eur.)

Sodium bicarbonate (BP)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions affecting water-electrolyte balance

Pharmacological Action

Plasma-substituting agent. Reduces hypovolemia, increases diuresis, reduces blood thickening and metabolic acidosis, improves capillary circulation, and has a detoxifying effect.

Indications

  • Correct dehydration and manage intoxication occurring concurrently with fluid and electrolyte loss.
  • Specifically indicated for severe infectious diarrheal diseases including cholera and acute shigellosis.
  • Employ for food toxicoinfection (bacterial food poisoning) where significant dehydration is a primary clinical concern.

ICD codes

ICD-10 code Indication
A00 Cholera
A03 Shigellosis
A05 Other bacterial food poisonings, not elsewhere classified
A08 Viral and other specified intestinal infections
A09 Other and unspecified gastroenteritis and colitis of infectious origin
ICD-11 code Indication
1A00 Cholera
1A02 Intestinal infections due to Shigella
1A1Z Bacterial foodborne intoxications, unspecified
1A2Z Viral intestinal infections, unspecified
1A40.Z Infectious gastroenteritis or colitis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer strictly by intravenous route, either as a bolus injection or as a controlled infusion.

Determine the dosing regimen individually for each patient, based on the specific indication, the degree of dehydration, and the clinical context.

Continuously monitor laboratory parameters during therapy, including serum electrolyte levels, acid-base status, and renal function, to guide the rate and volume of administration.

Adverse Reactions

Monitor for signs of fluid overload and electrolyte disturbances, including the development of peripheral or pulmonary edema.

Observe for systemic reactions such as tachycardia and chills during or following the infusion.

Assess for hyperkalemia, a potentially serious adverse effect, particularly in patients with compromised renal function; monitor for corresponding ECG changes.

Contraindications

  • Do not use in patients with known hypersensitivity to any of the active substances or excipients.
  • Avoid administration in the presence of alkalosis, hyperkalemia, or renal failure due to the risk of exacerbating these conditions.
  • Contraindicated for patients with chronic heart failure and in any clinical situation where the introduction of large fluid volumes is contraindicated.

Use in Pregnancy and Lactation

Used during pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding should be avoided due to the lack of relevant clinical data.

Use in Renal Impairment

Contraindicated in renal failure.

Special Precautions

In case of hyperkalemia development, this combination should be replaced with a sodium acetate/sodium chloride solution until the electrolyte balance normalizes. Before administration, warm the solution to 36-38°C (96.8-100.4°F).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Kursk Biofactory – Firm "BIOK", FKP (Russia)

Dosage Form

Bottle Rx Icon Trisol Solution for infusion 5 g+1 g+4 g/l: fl. 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion colorless transparent liquid.

1 l
Sodium chloride 5 g
Potassium chloride 1 g
Sodium bicarbonate 4 g

Excipients : water for injections – up to 1 l.

Ionic composition sodium ion – 133.2 mmol, potassium ion – 13.4 mmol, chloride ion – 99 mmol, bicarbonate ion – 47.6 mmol; theoretical osmolarity – 293 mOsm/l.

200 ml – glass bottles for blood with a capacity of 250 ml (1) – cardboard packs.
400 ml – glass bottles for blood with a capacity of 450 ml (1) – cardboard packs.
200 ml – glass bottles for blood with a capacity of 250 ml (20) – cardboard boxes (for hospitals).
200 ml – glass bottles for blood with a capacity of 250 ml (24) – cardboard boxes (for hospitals).
200 ml – glass bottles for blood with a capacity of 250 ml (28) – cardboard boxes (for hospitals).
400 ml – glass bottles for blood with a capacity of 450 ml (15) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Bottle Rx Icon Trisol Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml 1 or 28 pcs., 400 ml 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 5 g
Potassium chloride 1 g
Sodium bicarbonate 4 g

Excipients : water for injections – 1 l.

200 ml – bottles for blood substitutes (40) – cardboard boxes.
400 ml – bottles for blood substitutes (24) – cardboard boxes.
200 ml – bottles for blood substitutes (28) – cardboard boxes.
400 ml – bottles for blood substitutes (15) – cardboard boxes.

Marketing Authorization Holder

Nesvizh Medical Products Plant OJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Trisol Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 5 g
Potassium chloride 1 g
Sodium bicarbonate 4 g

200 ml – bottles for blood substitutes (40) – cardboard boxes.
400 ml – bottles for blood substitutes (24) – cardboard boxes.
400 ml – bottles for blood substitutes.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Trisol Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 5 g
Potassium chloride 1 g
Sodium bicarbonate 4 g

200 ml – bottles for blood substitutes (40) – cardboard boxes.
400 ml – bottles for blood substitutes (24) – cardboard boxes.
100 ml – bottles for blood and blood substitutes (56) – cardboard boxes.
200 ml – bottles for blood and blood substitutes (15) – cardboard boxes.
200 ml – bottles for blood and blood substitutes (28) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Trisol Solution for infusion 5 g+1 g+4 g/1 l: bot. 100 ml, 200 ml, 250 ml, 400 ml or 500 ml.

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 5 g
Potassium chloride 1 g
Sodium bicarbonate 4 g

200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.
250 ml – bottles (28) – cardboard boxes.
250 ml – bottles (1) – cardboard packs.
500 ml – bottles (15) – cardboard boxes.
500 ml – bottles (1) – cardboard packs.

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