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Ionoplasm (Solution) Instructions for Use

Marketing Authorization Holder

IST-Pharm, LLC (Russia)

Manufactured By

IST-Pharm, LLC (Russia)

Or

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

B05BB01 (Electrolytes)

Dosage Form

Bottle Rx Icon Ionoplasm Solution for infusion: bottles 250 mL or 500 mL

Dosage Form, Packaging, and Composition

Solution for infusion transparent, from colorless to brownish-yellow.

1 ml
Potassium chloride 0.37 mg
Magnesium chloride hexahydrate 0.3 mg
Sodium acetate trihydrate 3.68 mg
Sodium gluconate 5.02 mg
Sodium chloride 5.26 mg
Ionic composition:
   sodium 140 mmol/l (mEq/l)
   potassium 5 mmol/l (mEq/l)
   magnesium 1.5 mmol/l (3 mEq/l)
   chloride 98 mmol/l (mEq/l)
   acetate 27 mmol/l (mEq/l)
   gluconate 23 mmol/l (mEq/l)
Theoretical osmolarity 295 mOsm/l
PH 6.5-8.0

Excipients : hydrochloric acid solution 1 M or sodium hydroxide solution 1 M – to pH 6.5-8.0, water for injection – up to 1 ml.

250 ml – polyethylene bottles (1) – cardboard boxes.
500 ml – polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Electrolyte balance restoring agent

Pharmacological Action

A means for rehydration and detoxification. It corrects the acid-base state, replenishes the deficiency of fluid and electrolytes, enhances diuresis, has an antiplatelet property, reduces metabolic acidosis, improves microcirculation, and has a detoxifying, anti-shock effect.

Indications

As a component of infusion therapy as part of complex treatment in adults and children: shock; thermal injury; acute blood loss; hypotonic and isotonic forms of hypohydration and metabolic acidosis in severely ill patients; for the correction of water-salt balance in acute diffuse peritonitis and intestinal obstruction; patients with intestinal fistulas; decompensation of electrolyte disorders; patients with acute intestinal infections; dehydration; metabolic acidosis.

The volemic effect is short-lived; in the treatment of severe hypovolemia, a combination with colloidal solutions, as well as blood and its components, is recommended.

ICD codes

ICD-10 code Indication
A00 Cholera
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)
E87.2 Acidosis
K56.6 Other and unspecified intestinal obstruction
K63.2 Fistula of intestine
K65.0 Acute peritonitis (including abscess)
R57.1 Hypovolemic shock
R57.2 Septic shock
R57.8 Other types of shock
R58 Hemorrhage, not elsewhere classified
T30 Burns and corrosions of unspecified body region
T79.4 Traumatic shock
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
1A0Z Bacterial intestinal infections, unspecified
1A1Z Bacterial foodborne intoxications, unspecified
1A2Z Viral intestinal infections, unspecified
1A40.Z Infectious gastroenteritis or colitis, unspecified
1G41 Sepsis with septic shock
5C70.Z Decrease of volume of fluid [hypovolemia], unspecified
5C73.Z Acidosis, unspecified
DA91.Z Unspecified obstruction of small intestine
DA92.0 Fistula of small intestine
DB30.Z Unspecified obstruction of large intestine
DB31.0 Fistula of large intestine
DC50.0 Primary peritonitis
DC50.2 Peritoneal abscess
DC50.Z Peritonitis, unspecified
DE2Z Diseases of the digestive system, unspecified
ME24.1 Fistula of digestive system
MG27 Hemorrhage, not elsewhere classified
MG40.1 Hypovolemic shock
MG40.Z Shock, unspecified
NE11 Burn of unspecified body region
NF0A.4 Traumatic shock, not elsewhere classified

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.

IV, the dose depends on the age, body weight and condition of the patient.

In severe forms of diseases – IV bolus, in mild forms – IV drip.

Before administration, the solution is heated to body temperature. The initial dose is 5-10 drops, then a break is taken for 2-3 minutes to assess the results of the biological test, after which 30 drops are administered, followed by a break for 2-3 minutes. In the absence of individual intolerance, they switch to drip or jet administration in quantities necessary to restore the volume of fluid lost with feces, vomiting, urine, and sweat.

Adverse Reactions

Possible anaphylactoid reactions (tachycardia, decreased blood pressure, itching, skin hyperemia, shortness of breath, hyperthermia), hyperkalemia; allergic reactions.

Contraindications

Hyperkalemia; chronic renal failure; pulmonary edema; chronic heart failure grade II-III; arterial hypertension; hypertensive crisis; traumatic brain injury with increased intracranial pressure.

With caution

Diabetes mellitus (for solution with dextrose).

Use in Renal Impairment

Contraindication — chronic renal failure.

Special Precautions

In patients with renal, cardiac, or hepatic insufficiency, it is necessary to monitor the level of electrolytes in the plasma.

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

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