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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for infusion 5 g+1 g+4 g/l: fl. 200 ml or 400 ml
Marketing Authorization Holder
Kursk Biofactory – Firm "BIOK", FKP (Russia)
Dosage Form
| 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).
Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml 1 or 28 pcs., 400 ml 1 or 15 pcs.
Marketing Authorization Holder
Mosfarm LLC (Russia)
Dosage Form
| 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.
Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml, 400 ml
Marketing Authorization Holder
Nesvizh Medical Products Plant OJSC (Republic Of Belarus)
Dosage Form
| 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.
Solution for infusion 5 g+1 g+4 g/1 l: fl. 200 ml, 400 ml
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
| 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.
Solution for infusion 5 g+1 g+4 g/1 l: bot. 100 ml, 200 ml, 250 ml, 400 ml or 500 ml.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Dosage Form
| 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.
