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Disol (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substances

Sodium chloride (Ph.Eur.)

Sodium acetate (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

A combined drug for rehydration and detoxification. It restores the water-electrolyte balance and acid-base balance in the body during dehydration.

It prevents the development of metabolic acidosis and increases diuresis. It has plasma-substituting, detoxifying, and rehydrating effects.

Pharmacokinetics

It is excreted by the kidneys.

Indications

  • Restoration of fluid volume and correction of electrolyte imbalance in states of dehydration and volume depletion.
  • Treatment of hyperkalemia to lower elevated serum potassium levels.
  • Supportive detoxification therapy for intoxications accompanied by significant fluid loss, such as in cholera, acute dysentery, and other bacterial food poisonings.

ICD codes

ICD-10 code Indication
A00 Cholera
A02 Other salmonella infections
A03 Shigellosis
A04 Other bacterial intestinal infections
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
E86 Volume depletion (including dehydration, hypovolemia)
E87.5 Hyperkalemia
ICD-11 code Indication
1A00 Cholera
1A01 Intestinal infection caused by other Vibrio species
1A02 Intestinal infections due to Shigella
1A03.Z Intestinal infections caused by Escherichia coli, unspecified
1A09.Z Salmonella infection, unspecified
1A0Z Bacterial intestinal infections, unspecified
1A1Z Bacterial foodborne intoxications, unspecified
1A2Z Viral intestinal infections, unspecified
1A40.Z Infectious gastroenteritis or colitis, unspecified
5C70.Z Decrease of volume of fluid [hypovolemia], unspecified
5C76 Hyperkalemia

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 intravenously via bolus injection or continuous infusion. Determine the dosage, rate of administration, and total duration of therapy individually.

Base the regimen on the specific indication, the degree of fluid and electrolyte deficit, the patient’s age, body weight, and clinical condition. Continuously monitor hemodynamic status, electrolyte levels, and acid-base balance during infusion.

Adverse Reactions

Monitor for infusion-related reactions, including systemic manifestations such as chills and fever.

Observe the cardiovascular system for adverse effects like tachycardia, hypertension, or signs of fluid overload. Other potential reactions include localized or generalized edema due to sodium retention.

Contraindications

  • Hypersensitivity to any component of the formulation.
  • Patients with renal failure or severe renal impairment, due to the risk of electrolyte accumulation.
  • Individuals with chronic heart failure (CHF) or severe cardiac insufficiency, as the sodium load may exacerbate the condition.
  • Administration during pregnancy and the lactation period is contraindicated.

Exercise caution in patients with pre-existing hyperkalemia, as the formulation’s effect on potassium requires careful monitoring.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding). It is used during pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus.

Use in Renal Impairment

Contraindicated in renal failure.

Special Precautions

Therapy is carried out under the control of hematocrit and blood electrolyte concentrations.

Drug Interactions

Visually inspect for physical and chemical incompatibility when administering concomitantly with any other intravenous drug in the same line or container.

Be aware that the solution’s effect on electrolyte balance may alter the therapeutic or toxic potential of drugs affecting cardiac rhythm, such as antiarrhythmics or digitalis glycosides.

Overdose

Over-infusion may lead to hypervolemia, hyponatremia, hyperchloremia, or metabolic alkalosis due to the acetate component.

Discontinue the infusion immediately. Management is symptomatic and supportive, focusing on correcting fluid and electrolyte imbalances. Employ diuretics if significant fluid overload occurs. In severe cases, hemodialysis may be considered.

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

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

200 ml – bottles for blood and blood substitutes.
400 ml – bottles for blood and blood substitutes.

Marketing Authorization Holder

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 100ml, 200 ml, 400 ml, 2400 ml, 2800 ml, 4800 ml, 5600 ml, 6000 ml, 7500 ml, 12000 ml.

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

200 ml – bottles with a capacity of 250 ml (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
100 ml – bottles (56) – boxes.
200 ml – bottles (24) – boxes.
200 ml – bottles (28) – boxes.
400 ml – bottles (12) – boxes.
400 ml – bottles (15) – boxes.
100 ml – bags (56) – boxes.
200 ml – bags (24) – boxes.
200 ml – bags (28) – boxes.
400 ml – bags (12) – boxes.
400 ml – bags (15) – boxes.
500 ml – bags (15) – boxes.
500 ml – bags (12) – boxes.
1000 ml – bags (12) – boxes.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/l: 100 ml, 200 ml, 250 ml, 400 ml, 500 ml or 1000 ml bottle

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

Excipients : water for injection – up to 1 l.

100 ml – polypropylene bottles (1) – cardboard packs.
200 ml – polypropylene bottles (1) – cardboard packs.
250 ml – polypropylene bottles (1) – cardboard packs.
400 ml – polypropylene bottles (1) – cardboard packs.
500 ml – polypropylene bottles (1) – cardboard packs.
1000 ml – polypropylene bottles (1) – cardboard packs.
100 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).
200 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).
250 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).
400 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).
500 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).
1000 ml – polypropylene bottles (1-40) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion: bottle 200 ml, 250 ml, 400 ml or 450 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 ml
Sodium acetate trihydrate 2 mg
Sodium chloride 6 mg

Ionic composition (per liter): sodium ion – 117.3 mmol, chloride ion – 102.6 mmol, acetate ion – 14.7 mmol.
Excipients : water for injection – up to 1 ml.

Theoretical osmolarity 235 mOsm/l.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
450 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

200 ml – bottles (1) – cardboard packs (24) – cardboard boxes.
400 ml – bottles (1) – cardboard packs (12) – cardboard boxes.

Marketing Authorization Holder

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

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate 2 g

200 ml – bottles for blood and blood substitutes (1) – cardboard packs.
400 ml – bottles for blood and blood substitutes (1) – cardboard packs.

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

200 ml – bottles for blood substitutes (1) – cardboard packs (28) – cardboard boxes.
200 ml – bottles for blood substitutes (15) – cardboard boxes.
400 ml – bottles for blood substitutes (1) – cardboard packs (15) – cardboard boxes.

Marketing Authorization Holder

Nesvizh Medical Products Plant OJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion 1 l
Sodium chloride 6 g
Sodium acetate trihydrate 2 g

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

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

NPC Eskom, PJSC (Russia)

Or

KFK Mir, LLC (Russia)

Or

Medpolymer Firm, JSC (Russia)

Dosage Form

Bottle Rx Icon Disol Infusion solution 2 g+5 g+1 g/1 L: bottles or vials 25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL or 500 mL, containers 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, 750 mL, 800 mL or 1000 mL

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a colorless, transparent liquid.

1 l
Sodium acetate trihydrate 2 g
Sodium chloride 6 g
Ionic composition
   Sodium ion 127 mmol/l
   Chloride ion 103 mmol/l
   Acetate ion 24 mmol/l

Excipients : water for injection – up to 1 l.

Theoretical osmolarity 254 mOsm/l.

25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – bottles (1) – cardboard packs.
25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – vials (1) – cardboard packs.
25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – vials (1) – polymer bags.
50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 750 ml, 800 ml or 1000 ml – polymer containers for single-use infusion solutions (1) with SFC type injection ports (1) – bags (1) – cardboard boxes.
50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 750 ml, 800 ml or 1000 ml – polymer containers for single-use infusion solutions (1) with SFC type injection ports (2) – bags (1) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Disol Solution for infusion 6 g+2 g/1 l: bottle 100 ml, 200 ml, 250 ml, 400 ml, or 500 ml

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a colorless, transparent liquid.

1 l
Sodium acetate trihydrate 2 g
Sodium chloride 6 g
Ionic composition
   Sodium ion 127 mmol
   Chloride ion 103 mmol
   Acetate ion 24 mmol

Excipients : water for injection – up to 1 l.

Theoretical osmolarity 254 mOsm/l.

100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
500 ml – bottles (1) – cardboard packs.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (28) – cardboard boxes.
250 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.
500 ml – bottles (15) – cardboard boxes.
100 ml – polymer containers (72) – cardboard boxes.
250 ml – polymer containers (34) – cardboard boxes.
500 ml – polymer containers (22) – cardboard boxes.

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