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Ringer-Acetate (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

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 that eliminates metabolic acidosis and normalizes the acid-base and water-electrolyte composition of the blood.

The therapeutic effect of the drug is due to a temporary increase in the volume of circulating blood, replenishment of the deficiency of sodium, potassium, and calcium, as well as the conversion of the acetate ion into bicarbonate.

Indications

Shock; thermal injury; acute blood loss; hypohydration (isotonic and hypotonic forms); metabolic acidosis; acute diffuse peritonitis; intestinal obstruction (to correct water and salt balance); decompensation of electrolyte disturbances in patients with intestinal fistulas; therapeutic plasmapheresis (dialysis-filtration method).

ICD codes

ICD-10 code Indication
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)
R57.0 Cardiogenic shock
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
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
MG40.0 Cardiogenic shock
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.

Administer the solution by intravenous infusion only.

Determine the dosage and infusion rate individually based on the patient’s condition, degree of fluid and electrolyte deficit, age, and body weight.

For adults, the typical daily dose is 5-20 ml/kg of body weight.

In cases of severe fluid loss or shock, increase the adult dose to 30-40 ml/kg daily.

For pediatric patients, the daily dose is 5-10 ml/kg.

Adjust the infusion rate for children to 30-60 drops per minute; control the rate carefully to avoid circulatory overload.

In severe hypovolemia, use this solution as part of a combined therapy with colloidal solutions or blood products.

When administering large volumes or for prolonged therapy, monitor the patient’s clinical status, electrolyte levels in plasma and urine, acid-base balance, and renal function.

Do not administer if the solution is discolored or contains particulate matter.

Adverse Reactions

Systemic reactions: allergic reactions, when large volumes of solution are administered: hyperhydration, chloride acidosis, hypernatremia, hypokalemia.

Contraindications

Hypersensitivity; alkalosis; extracellular hyperhydration; hypertonic dehydration; hypernatremia; conditions in which the administration of large volumes of fluid is contraindicated: severe chronic heart failure, cerebral edema, pulmonary edema, anuria.

With caution

Heart failure, arterial hypertension, renal and/or hepatic insufficiency, oliguria.

Use in Hepatic Impairment

With caution in hepatic insufficiency.

Use in Renal Impairment

With caution in renal insufficiency.

Pediatric Use

The daily dose for children is 5-10 ml/kg, the rate of administration is 30-60 drops/min.

Special Precautions

When treating severe hypovolemia, simultaneous therapy with colloidal solutions, blood and its components is recommended (due to the short duration of action of the drug).

When administering large doses of the solution for a long time, it is advisable to monitor electrolytes in plasma and urine.

Drug Interactions

Increased sodium retention in the body is possible with simultaneous use of NSAIDs, androgens, estrogens, anabolic hormones, corticotropin, mineralocorticoids, vasodilators or ganglioblockers.

When taken with potassium-sparing diuretics – the development of hyperkalemia.

Calcium in combination with cardiac glycosides increases the likelihood of their toxic effects.

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

IST-Pharm, LLC (Russia)

Manufactured By

IST-Pharm, LLC (Russia)

Or

Pharmasintez-Tyumen, LLC (Russia)

Dosage Form

Bottle Rx Icon Ringer-Acetate Solution for infusion: bot. 250 ml or 500 ml

Dosage Form, Packaging, and Composition

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

1 L
Sodium chloride 5.91 g
Sodium acetate calculated as anhydrous 2.82 g
Potassium chloride 0.3 g
Calcium chloride calculated as anhydrous 0.22 g
Magnesium chloride calculated as anhydrous 0.095 g
Ionic composition
   Sodium ion 135 mmol
   Potassium ion 4 mmol
   Calcium ion 2 mmol
   Magnesium ion 1 mmol
   Chloride ion 108 mmol
   Acetate ion 34 mmol

Excipients: water for injection – up to 1 L.

Theoretical osmolarity: 284 mOsmol/L.

250 ml – bottles (1) – cardboard boxes.
500 ml – bottles (1) – cardboard boxes.
250 ml – bottles (1) – sealed bags (1) – cardboard boxes.
500 ml – bottles (1) – sealed bags (1) – cardboard boxes.

Marketing Authorization Holder

KFK Medpolymer, LLC (Russia)

Dosage Form

Bottle Rx Icon Ringer-Acetate Solution for infusion: containers 100 ml, 250 ml, 500 ml or 1000 ml.

Dosage Form, Packaging, and Composition

Solution for infusion 1 L
Potassium chloride 300 mg
Calcium chloride 220 mg
Magnesium chloride 95 mg
Sodium acetate 2.82 g
Sodium chloride 5.91 g

100 ml – polymer containers (1) – polymer bags.
250 ml – polymer containers (1) – polymer bags.
500 ml – polymer containers (1) – polymer bags.
1000 ml – polymer containers (1) – polymer bags.

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