CONCENTRATED POLYELECTROLYTE SOLUTION WITHOUT POTASSIUM MONICO
CONCENTRATE FOR INFUSION SOLUTION
PHARMACOTHERAPEUTIC CATEGORY
Electrolyte solutions.
THERAPEUTIC INDICATIONS
Treatment of hyponatremia due to loss or inadequate intake of sodium.
Treatment of mild or moderate, but not severe, metabolic acidosis.
CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients;
hypernatremia;
hydro-saline plethora;
lactic acidosis;
impaired oxidative processes preventing lactate utilization (e.g., shock, hypoxemia);
severe hepatic insufficiency (inability to metabolize acetate ion);
metabolic and respiratory alkalosis.

PRECAUTIONS FOR USE
Due to the presence of sodium, use with caution in patients with congestive heart failure, severe renal
insufficiency, and in clinical conditions associated with edema and salt retention; in patients receiving
cardiotonic inotropic drugs or corticosteroid or corticotropin drugs, and in patients with metabolic or
respiratory alkalosis.
Sodium salts should be administered cautiously in patients with hypertension, heart failure, peripheral or
pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium
retention (see Interactions).
Continuous administration without potassium supplementation may lead to hypokalemia.
Due to the presence of acetate, use with caution in patients with metabolic or respiratory alkalosis and in
conditions characterized by increased levels or inadequate utilization of this ion, such as severe hepatic
insufficiency.
During infusion, it is advisable to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base
equilibrium.
INTERACTIONS
Inform the physician or pharmacist if you have recently taken any other medicinal products, including those
not requiring a prescription.
Corticosteroids are associated with sodium and water retention, leading to edema and hypertension:
therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see
Precautions for Use).
SPECIAL WARNINGS
The solution must be clear, colorless, and free from visible particles. Use immediately after opening the
container. The container is intended for single, uninterrupted administration; any residual solution must not
be used.
Pregnancy and Lactation
Consult your physician or pharmacist before taking any medicinal product.
No data are available regarding potential adverse effects of the medicinal product when administered during
pregnancy or lactation, or on reproductive capacity.
Therefore, the medicinal product should not be used during pregnancy or lactation unless absolutely
necessary and only after careful assessment of the risk/benefit ratio.
Effects on the ability to drive and use machines
The medicinal product does not affect the ability to drive or operate machinery.
DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
The medicinal product must not be injected undiluted but should be administered cautiously by intravenous
infusion only after dilution or mixing with compatible solutions (see at the end of this section) and at a
controlled infusion rate.
Dosage depends on the patient's age, weight, and clinical condition in relation to the calculated sodium deficit.
In cases of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia,
administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1–2 mmol/L/hour.
Ensure that correction does not exceed 10–12 mmol/L in 24 hours and 18 mmol/L in 48 hours.
The safety and efficacy of concentrated polyelectrolyte solution without potassium have not been established
in children.
Incompatibilities with Concentrated Polyelectrolyte Solution without Potassium MONICO
Not known.
Solutions suitable for dilution of Concentrated Polyelectrolyte Solution without Potassium MONICO
5% glucose solutions, 0.9% sodium chloride solutions (physiological saline), or other compatible solutions.
Dilute the solution immediately after opening the container; the diluted solution must be used immediately.
The diluted solution must be clear, colorless, and free from visible particles. It is intended for single,
uninterrupted administration; any residual solution must not be used.
Do not use the medicinal product if the solution is not clear and colorless or contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
OVERDOSE
Symptoms
Excessive administration of concentrated polyelectrolyte solution without potassium may lead, depending on
the patient's clinical condition, to hypernatremia and/or hypervolemia.
Hypernatremia and excessive sodium retention, particularly when renal sodium excretion is impaired, may
cause dehydration of internal organs, especially the brain, and accumulation of extracellular fluid leading to
edema affecting the cerebral, pulmonary, and peripheral circulation, possibly resulting in pulmonary and
peripheral edema.
Accumulation of chloride ions reduces bicarbonate ion concentration, leading to acidosis.
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions
and, if necessary, restore acid-base balance (see Precautions for Use).
The patient should be closely monitored for any signs or symptoms related to the administered medicinal
product, with appropriate symptomatic and supportive measures provided as needed.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions
(which are effectively hypotonic in hypernatremic patients) is recommended.
In cases of marked hypernatremia, loop diuretics may be used.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.
In case of accidental ingestion/overdose of Concentrated Polyelectrolyte Solution without Potassium MONICO,
contact a physician immediately or go to the nearest hospital.
If you have any doubts about the use of Concentrated Polyelectrolyte Solution without Potassium MONICO,
consult your physician or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, Concentrated Polyelectrolyte Solution without Potassium may cause adverse
reactions, although not everyone experiences them.
The following are the adverse reactions associated with Concentrated Polyelectrolyte Solution without
Potassium. Sufficient data are not available to determine the frequency of individual listed reactions.
Gastrointestinal disorders
Thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain.
Nervous system disorders
Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death.
Cardiac disorders
Tachycardia.
Psychiatric disorders
Somnolence, confusion.
Respiratory, thoracic and mediastinal disorders
Dyspnea, respiratory arrest, pulmonary edema.
Eye disorders
Reduced lacrimation.
Renal and urinary disorders
Renal failure.
Vascular disorders
Hypertension, peripheral edema.
Disorders of water and electrolyte balance
Hypernatremia, hypervolemia, hypoosmolarity, hypokalemia, hyperchloremia.
Systemic disorders and administration site conditions
Fever, infusion site infection, pain or local reaction, venous irritation, thrombosis or phlebitis extending from
the infusion site, extravasation, tissue necrosis.
Following the instructions in the package leaflet reduces the risk of adverse reactions.
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform
your physician or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in unopened packaging, stored correctly.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of unused medicinal products. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
COMPOSITION
Each vial (10 ml) contains:
Active substances: sodium lactate 60% 0.934 g
sodium chloride 1.17 g
sodium acetate trihydrate 0.68 g
Excipients: water for injections q.s.
mEq/10 ml Na 30
Cl 20
lactate as HCO₃⁻ 5
acetate as HCO₃⁻ 5
pH: 7.0 ÷ 7.8
PHARMACEUTICAL FORM AND CONTENT
Sterile, pyrogen-free concentrate for infusion solution.
Carton containing 5 vials of pharmaceutical glass, 10 ml each.
MARKETING AUTHORIZATION HOLDER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE
MANUFACTURER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE
8 March 2013

Concentrated polysaline solution without potassium